Archive for the ‘Bone Marrow Stem Cells’ Category
It’s time for Kentucky to talk to expectant parents about benefits of cord blood banking – Courier Journal
Paula Grisanti, Opinion contributor Published 6:20 a.m. ET Nov. 9, 2020
This year, Nov.17 has been designated World Cord Blood Day, an annual event to raise awareness for the life-saving benefits of cord blood transplants while educating parents, health professionals and the general public about the need to preserve these precious cells.
Cord blood transplants are being used to treat more than 80 different diseases and conditions including blood cancers like leukemia and lymphoma, neuroblastoma (the most common cancer in infants), bone-marrow failure disorders, inherited blood disorders and rare immune system disorders. They are also showing new promise for conditions that have never had treatment options, like autism and brain injury.
The first cord blood stem cell transplant, an international effort between physicians in the U.S. and Europe, was performed in France in 1988. Stem cells collected from a newborns umbilical cord blood were used to save the life of her brother, a 5-year-old with Fanconi Anemia. Since then, there have been more than 40,000 cord blood transplants performed worldwide.
Now standard of care for cancers of the blood and a host of other life-threatening diseases, blood forming stem cells for transplantation can be collected from bone marrow, circulating bloodor a newborn babys umbilical cord blood. Some experts believe cord blood contains nearly 10 times the number of stem cells found in bone marrow.
Because umbilical cord stem cells are less mature than adult bone marrow stem cells, they are also less likely to be rejected and can be used when there isnt a perfect match.
Between these threeoptions, the easiest collection by far is from umbilical cord and placental tissue after a baby is born and the umbilical cord has been cut, at no risk to mother or child, in a process that typically takes 5 to 10 minutes. The cells are then frozen in liquid nitrogen and can be stored indefinitely in private or public cord blood banks.
To store your babys cord blood for use by your child and your family only, you make arrangements with a private cord blood bank ahead of delivery to collect and store the cells; the cost to you includes a collection fee of $1,500 to $2,000 and an annual storage fee of $100 to $125.
If you cant afford or dont wish to save your babys cord blood stem cells, you can donate them to a public cord blood bank at no cost to you or your family.
Its the equivalent of registering these potentially life-saving cells with the national bone marrow registry; they will be available to the families of other children who need to find a bone marrow match after a devastating diagnosis. Without information and education, however, 95% of all cord blood is discarded as medical waste.
Right now, there is no public cord banking option in Kentucky, although public cord blood banking is highly recommended by both the American Academy of Pediatrics (AAP) and the American Medical Association (AMA). There are fewer than 25 public or hybrid cord blood banks in the U.S., many limited to a specific geographic area. None of them include Kentucky.
The chances of finding a bone marrow match in your family are only about 25%, making the bone marrow and umbilical cord blood registries a lifeline in desperate situations. Odds are worse for African Americans and other ethnic minorities who are underrepresented on the registry and ethnicity matters in a bone marrow transplant.
Donating cord blood cells to a public bank adds to the library of cells that may save someones life and increases the chance of a match for all of us. Who benefits most? Children, patients with rare human leukocyte antigen (HLA) types and ethnic minorities.
We need to do two things: Make public cord blood banking an option in the commonwealth of Kentucky, and then encourage conversations between health care providers and expectant parents about preserving these life-saving cells.
There are 28 states with legislation that ask or mandates physicians to talk to expectant parents about cord blood banking. Kentucky is not one of them, but most of our surrounding states have such legislation in place.
Through a long-standing relationship between the National Stem Cell Foundationand world-renowned cord blood expert Dr. Joanne Kurtzberg, we have a path forward for training hospitals and collecting cells for storage at the Carolinas Cord Blood Bank (CCBB), one of the largest public cord blood banks in the world. Dr. Kurtzberg directs both the Pediatric Blood and Marrow Transplant (PBMT) program at Duke University and the CCBB.
She performed the worlds first unrelated cord blood transplant in 1993, paving the way for this now routine source of donor cells for children who need a bone marrow transplant and dont have a matched donor. She established the CCBB in 1998.
Paula Grisanti is CEO of the National Stem Cell Foundation.(Photo: provided)
While weve initiated discussions between Louisville hospital systems and the CCBB, we need to begin the process of education for parents, nursing and medical school students, residents, midwives, practicing OB-GYNs and the general public.
What a waste to discard these life-saving cells the future of current and developing therapies for disabling and life-threatening diseases depends on our ability to make sure that doesnt happen.
Dr. Paula Grisanti is CEO and a founding member of the National Stem Cell Foundation, headquartered in Louisville, Kentucky. She holds a D.M.D. and MBA from the University of Louisville and has been actively involved in new venture start-ups for most of her career.
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It's time for Kentucky to talk to expectant parents about benefits of cord blood banking - Courier Journal
Reynoldsburg man makes unusual birthday wish: ‘I wanted to save someone’s life’ – 10TV
Troy McKinley donated stem cells to help a stranger with blood cancer.
Think about your birthday wish this year? Did it involve saving someone's life?
A Reynoldsburg man's wish did.
Thirty-five-year-olf Troy McKinely wanted to make sure his birthday wish made a difference in someone else's life.
I wanted to do something big if possible. I've never donated blood before I don't even like needles, he said.
Two years ago, he decided he wanted to make his birthday more about gifts, and instead give the gift of life.
I thought it would be great to save a life so what can I do to help, he said
He found DKMS, the world's largest bone marrow and blood stem cell donor center.
The company sent him a swab kit and he waited to see if he would be a match. Two and a half years later, he was notified that his stem cells matched a patient who was diagnosed with blood cancer.
It was kind of like 'wow this is big. I don't know this person. I don't know anything about him or her.' It's kind of amazing feeling that it could be better for somebody else, he said.
McKinley said it only took a few hours to give the needed stem cells that doctors would later implant to the unknown patient.
I'm hoping that this gentleman I helped is feeling better for it and helped him in some way. Maybe it didn't give him everything back but he has some more time and we all want more time in the world so hopefully, it helped him, he said.
Time, we can all use more of it, but how many of us take the time to think about how we can give others more days on this earth.
It was a birthday wish McKinley says he'd do again knowing his kindness gave a stranger something more valuable than anything.
I think it's amazing to save someone's life. It's an incredible experience, he said.
About DKMS
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Reynoldsburg man makes unusual birthday wish: 'I wanted to save someone's life' - 10TV
Stanford coach’s quest to save his brother: ‘God, I hope this works’ – Scope
During a 2018 home game against Washington State University, David Shaw, Stanford's football coach, ambled slowly along the sideline, his joints aching.
Wanting to focus on the players and the game, he kept the reason for his lethargy to himself. But two years later, this past Saturday, the sports world learned the full story.
A College GameDay feature on ESPN revealed that the morning before the game, Shaw had been given stem-cell-inducing medication at Stanford Hospital. It was a first step in donating the cells to his brother, Eric Shaw, who was fighting a rare form of lymphoma.
In the opening of the six-minute video, Shaw says he thought, "'God, I hope this works, 'cause if it doesn't, I'm going to lose my brother.'"
Eric Shaw began noticing strange dark patches on his skin in 2011, the year his older brother became Stanford's head football coach. They were everywhere, from head to foot. Later, small tumors popped up all over his body.
"I would have itching attacks where I would end up actually tearing my skin," he says in the video. "I would still scratch at night and end up with bloody arms and legs."
Eric Shaw transferred his medical care to the Stanford Cancer Center in 2013. There, physicians told the financial services marketing professional that he needed to start radiation treatment immediately. It worked, but only briefly: Six months later, the cancer returned.
He was diagnosed with mycosis fungoides, a T cell lymphoma that affects fewer than four in a million people in the United States.
Shaw's physicians began discussing bone marrow transplant. David Shaw was tested as a donor, but he scored only 5 on a 10-point match scale. A worldwide search found closer matches, and Eric Shaw underwent radiation and chemotherapy to prepare for the transplant.
One attempt failed, then another.
"You think you've kind of pulled at the last thread, and there are no more threads, and all I could tell him was that I loved him and that I was there for him," David Shaw says in the video.
But the Stanford physicians had one last weapon: a haploidentical transplant. The recently developed technique uses stem cells, typically from a family member, that are less than a perfect match.
David Shaw underwent a five-day-long process at Stanford Hospital to donate the cells. He received medication that caused him to produce an abundance of stem cells, then gave blood from which the cells were extracted. Those cells were then transplanted into his brother.
This time, it worked.
After 52 days at Stanford Hospital, Eric Shaw finally went home on Nov. 25, 2018. The video shows him being wheeled out as medical staff members cheer him on.
Youn Kim, MD, who treated Eric and heads Stanford's multidisciplinary Cutaneous Lymphoma Clinic/Program, told ESPN: "If he didn't go for this risk, he wouldn't be here...He wouldn't be living."
As the article notes, Stanford physicians Wen-Kai Weng, MD, PhD, and Michael Khodadoust, MD, PhD, also were on the team treating Eric Shaw.
Today, nearly two years later, he remains cancer-free.
"Seven years of battling this disease, and it was over," he says in the video, tears running down his face. "A miracle."
David Shaw shares his brother's joy. As he told ESPN: "Every time I see him, I just smile, you know? Because he gets to be here."
Images of Eric Shaw, left, taken earlier this month, and his brother David Shaw, courtesy of the Shaw family, and Stanford Athletics
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Stanford coach's quest to save his brother: 'God, I hope this works' - Scope
Rheumatoid Arthritis Stem Cell Therapy Market to Ride on Increased Prevalence of Rheumatoid Arthritis – TMR Research Blog
Rheumatoid arthritis refers to an inflammatory disease of the supportive tissues of the body and the condition generally affects fingers and toes of human beings. This inflammation is caused by an abnormal response of the body to the normal functioning tissues. This leads to acute pain and malformed joints. Novel cells that are produced by regenerative centers of the body are called stem cells. These cells can be changed into any other type of cell in the body with just the right kind of stimulant. The growth of the global rheumatoid arthritis stem cell therapy market is likely to observe growth in its ability to demonstrate profound healing activity. It also helps in checking the arthritic condition. In addition to that, this therapy is capable of regenerating and reversing joint tissue in many cases, which is likely to pave way for rapid growth of the global rheumatoid arthritis stem cell therapy market in the years to come.
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Ability to Diminish Pain and Inflammation to Bolster Demand in the Market
In present times, human umbilical cord tissue (allogeneic mesenchymal stem cells), fat-derived or adipose stem cells, and bone marrow transplant are utilized for the purpose of the rheumatoid arthritis stem cell therapy. As the condition becomes worse, the body starts autoimmune response and keeps on attacking the cells of the body. The global rheumatoid arthritis stem cell therapy market is estimated to gather momentum from its growing importance and popularity in specialty clinics, ambulatory surgical centers, and hospitals. This therapy comes with the excellent healing capabilities that can treat the entire system causing inflammation and joint pain.
Extensive growth opportunities of the global rheumatoid arthritis stem cell therapy market are likely to be influenced by the multiple benefits offered by this therapy. However, this therapy comes with its own share of disadvantages as well and is not an infallible method for healing arthritis. All though, this therapy is capable of assisting in the stabilization of the body immune system and diminish inflammation.
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Rheumatoid Arthritis Stem Cell Therapy Market to Ride on Increased Prevalence of Rheumatoid Arthritis - TMR Research Blog
Stem Cell Banking Market To See Massive Growth By 2027| Cryo-Save AG, StemCyte India Therapeutics, SMART CELLS PLUS, Vita 34, LifeCell – PRnews Leader
Stem cell banking or preservation is a combined process of extraction, processing and storage of stem cells, so that they may be used for treatment of various medical conditions in the future, when required. Stem cells have the amazing power to get transformed into any tissue or organ in the body. In recent days, stem cells are used to treat variety of life-threatening diseases such as blood and bone marrow diseases, blood cancers, and immune disorders among others.
The study provides details such as the market share, Market Insights, Strategic Insights, Segmentation and key players in the Stem Cell Banking Market.
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The global stem cell banking market is segmented on the basis of source, service type, and application. The source segment includes, placental stem cells (PSCS), dental pulp-derived stem cells (DPSCS), bone marrow-derived stem cells (BMSCS), adipose tissue-derived stem cells (ADSCS), human embryo-derived stem cells (HESCS), and other stem cell sources. Based on service type the market is segmented into, sample processing, sample analysis, sample preservation and storage, sample collection and transportation. Based on application, the market is segmented as, clinical applications, research applications, and personalized banking applications.
Note The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries. This report on Stem Cell Banking Market provides the analysis on impact on Covid-19 on various business segments and country markets. The reports also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.
The researchers have analysed the competitive advantages of those involved in the industries or in the In Stem Cell Banking industry. While historical years were taken as 2020 2027, the base year for the study was 2020. Similarly, the report has given its projection for the year 2020 apart from the outlook for years 2020 2027.
Some of the Major Market Players Are:
Cordlife, ViaCord (A Subsidiary of PerkinElmer), Cryo-Save AG, StemCyte India Therapeutics Pvt. Ltd., Cryo-Cell International, Inc., SMART CELLS PLUS, Vita 34, LifeCell, Global Cord Blood Corporation, CBR Systems
The objective of the researchers is to find out the sales, value, and status of the In Stem Cell Banking industry at the international levels. While the status covers the years of 2020 2027, the forecast is for the period 2020 2027 that will enable market players to not only plan but also execute strategies based on the market needs.
The study wanted to focus on key manufacturers, competitive landscape, and SWOT analysis for the In Stem Cell Banking Market. Apart from looking into the geographical regions, the report concentrated on key trends and segments that are either driving or preventing the growth of the industry. Researchers have also focused on individual growth trends besides their contribution to the overall market.
An outline of the regional analysis:
In Stem Cell Banking market recent innovations and major events.
Additional highlights of the In Stem Cell Banking market report:
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Stem Cell Banking Market To See Massive Growth By 2027| Cryo-Save AG, StemCyte India Therapeutics, SMART CELLS PLUS, Vita 34, LifeCell - PRnews Leader
Impact Of Covid-19 on Stem Cell Banking Market 2020 Industry Challenges, by Key Players, Types, Applications, Countries, Market Size, Forecast to 2026…
Overview for Stem Cell Banking Market Helps in providing scope and definitions, Key Findings, Growth Drivers, and Various Dynamics.
The Stem Cell Banking market is expected to grow from USD X.X million in 2020 to USD X.X million by 2026, at a CAGR of X.X% during the forecast period. The global Stem Cell Banking market report is a comprehensive research that focuses on the overall consumption structure, development trends, sales models and sales of top countries in the global Stem Cell Banking market. The report focuses on well-known providers in the global Stem Cell Banking industry, market segments, competition, and the macro environment.
Under COVID-19 Outbreak, how the Stem Cell Banking Industry will develop is also analyzed in detail in Chapter 1.7 of the report., In Chapter 2.4, we analyzed industry trends in the context of COVID-19., In Chapter 3.5, we analyzed the impact of COVID-19 on the product industry chain based on the upstream and downstream markets., In Chapters 6 to 10 of the report, we analyze the impact of COVID-19 on various regions and major countries., In chapter 13.5, the impact of COVID-19 on the future development of the industry is pointed out.
A holistic study of the market is made by considering a variety of factors, from demographics conditions and business cycles in a particular country to market-specific microeconomic impacts. The study found the shift in market paradigms in terms of regional competitive advantage and the competitive landscape of major players.
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Key players in the global Stem Cell Banking market covered in Chapter 4:, Boyalife, StemCyte, Crioestaminal, Esperite, Americord, Cryo-cell, PBKM FamiCord, Beikebiotech, PacifiCord, RMS Regrow, Stemade Biotech, Krio, CCBC, Cordlife Group, Cellsafe Biotech Group, Vcanbio, Familycord, ViaCord, Cells4life, LifeCell, CBR, Cryo Stemcell
In Chapter 11 and 13.3, on the basis of types, the Stem Cell Banking market from 2015 to 2026 is primarily split into:, Placental Stem Cells (PSCs), Human Embryo-derived Stem Cells (HESCs), Bone Marrow-derived Stem Cells (BMSCs), Adipose Tissue-derived Stem Cells (ADSCs), Dental Pulp-derived Stem Cells (DPSCs), Other Stem Cell Sources
In Chapter 12 and 13.4, on the basis of applications, the Stem Cell Banking market from 2015 to 2026 covers:, Personalized Banking Applications, Clinical Applications, Hematopoietic Disorders, Autoimmune Disorders, Other Diseases, Research Applications, Disease Treatment Studies, Life Science Research, Drug Discovery
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Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:, North America (Covered in Chapter 6 and 13), United States, Canada, Mexico, Europe (Covered in Chapter 7 and 13), Germany, UK, France, Italy, Spain, Russia, Others, Asia-Pacific (Covered in Chapter 8 and 13), China, Japan, South Korea, Australia, India, Southeast Asia, Others, Middle East and Africa (Covered in Chapter 9 and 13), Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Others, South America (Covered in Chapter 10 and 13), Brazil, Argentina, Columbia, Chile, Others
Years considered for this report:, Historical Years: 2015-2019, Base Year: 2019, Estimated Year: 2020, Forecast Period: 2020-2026
Some Point of Table of Content:
Chapter One: Report Overview
Chapter Two: Global Market Growth Trends
Chapter Three: Value Chain of Stem Cell Banking Market
Chapter Four: Players Profiles
Chapter Five: Global Stem Cell Banking Market Analysis by Regions
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Chapter Six: North America Stem Cell Banking Market Analysis by Countries
Chapter Seven: Europe Stem Cell Banking Market Analysis by Countries
Chapter Eight: Asia-Pacific Stem Cell Banking Market Analysis by Countries
Chapter Nine: Middle East and Africa Stem Cell Banking Market Analysis by Countries
Chapter Ten: South America Stem Cell Banking Market Analysis by Countries
Chapter Eleven: Global Stem Cell Banking Market Segment by Types
Chapter Twelve: Global Stem Cell Banking Market Segment by Applications12.1 Global Stem Cell Banking Sales, Revenue and Market Share by Applications (2015-2020)12.1.1 Global Stem Cell Banking Sales and Market Share by Applications (2015-2020)12.1.2 Global Stem Cell Banking Revenue and Market Share by Applications (2015-2020)12.2 Personalized Banking Applications Sales, Revenue and Growth Rate (2015-2020)12.3 Clinical Applications Sales, Revenue and Growth Rate (2015-2020)12.4 Hematopoietic Disorders Sales, Revenue and Growth Rate (2015-2020)12.5 Autoimmune Disorders Sales, Revenue and Growth Rate (2015-2020)12.6 Other Diseases Sales, Revenue and Growth Rate (2015-2020)12.7 Research Applications Sales, Revenue and Growth Rate (2015-2020)12.8 Disease Treatment Studies Sales, Revenue and Growth Rate (2015-2020)12.9 Life Science Research Sales, Revenue and Growth Rate (2015-2020)12.10 Drug Discovery Sales, Revenue and Growth Rate (2015-2020)
Chapter Thirteen: Stem Cell Banking Market Forecast by Regions (2020-2026) continue
List of tablesList of Tables and FiguresTable Global Stem Cell Banking Market Size Growth Rate by Type (2020-2026)Figure Global Stem Cell Banking Market Share by Type in 2019 & 2026Figure Placental Stem Cells (PSCs) FeaturesFigure Human Embryo-derived Stem Cells (HESCs) FeaturesFigure Bone Marrow-derived Stem Cells (BMSCs) FeaturesFigure Adipose Tissue-derived Stem Cells (ADSCs) FeaturesFigure Dental Pulp-derived Stem Cells (DPSCs) FeaturesFigure Other Stem Cell Sources FeaturesTable Global Stem Cell Banking Market Size Growth by Application (2020-2026)Figure Global Stem Cell Banking Market Share by Application in 2019 & 2026Figure Personalized Banking Applications DescriptionFigure Clinical Applications DescriptionFigure Hematopoietic Disorders DescriptionFigure Autoimmune Disorders DescriptionFigure Other Diseases DescriptionFigure Research Applications DescriptionFigure Disease Treatment Studies DescriptionFigure Life Science Research DescriptionFigure Drug Discovery DescriptionFigure Global COVID-19 Status OverviewTable Influence of COVID-19 Outbreak on Stem Cell Banking Industry DevelopmentTable SWOT AnalysisFigure Porters Five Forces AnalysisFigure Global Stem Cell Banking Market Size and Growth Rate 2015-2026Table Industry NewsTable Industry PoliciesFigure Value Chain Status of Stem Cell BankingFigure Production Process of Stem Cell BankingFigure Manufacturing Cost Structure of Stem Cell BankingFigure Major Company Analysis (by Business Distribution Base, by Product Type)Table Downstream Major Customer Analysis (by Region)Table Boyalife ProfileTable Boyalife Production, Value, Price, Gross Margin 2015-2020Table StemCyte ProfileTable StemCyte Production, Value, Price, Gross Margin 2015-2020Table Crioestaminal ProfileTable Crioestaminal Production, Value, Price, Gross Margin 2015-2020Table Esperite ProfileTable Esperite Production, Value, Price, Gross Margin 2015-2020Table Americord ProfileTable Americord Production, Value, Price, Gross Margin 2015-2020Table Cryo-cell ProfileTable Cryo-cell Production, Value, Price, Gross Margin 2015-2020Table PBKM FamiCord ProfileTable PBKM FamiCord Production, Value, Price, Gross Margin 2015-2020Table Beikebiotech ProfileTable Beikebiotech Production, Value, Price, Gross Margin 2015-2020Table PacifiCord ProfileTable PacifiCord Production, Value, Price, Gross Margin 2015-2020Table RMS Regrow ProfileTable RMS Regrow Production, Value, Price, Gross Margin 2015-2020Table Stemade Biotech ProfileTable Stemade Biotech Production, Value, Price, Gross Margin 2015-2020Table Krio ProfileTable Krio Production, Value, Price, Gross Margin 2015-2020Table CCBC ProfileTable CCBC Production, Value, Price, Gross Margin 2015-2020Table Cordlife Group ProfileTable Cordlife Group Production, Value, Price, Gross Margin 2015-2020Table Cellsafe Biotech Group ProfileTable Cellsafe Biotech Group Production, Value, Price, Gross Margin 2015-2020Table Vcanbio ProfileTable Vcanbio Production, Value, Price, Gross Margin 2015-2020Table Familycord ProfileTable Familycord Production, Value, Price, Gross Margin 2015-2020Table ViaCord ProfileTable ViaCord Production, Value, Price, Gross Margin 2015-2020Table Cells4life ProfileTable Cells4life Production, Value, Price, Gross Margin 2015-2020Table LifeCell ProfileTable LifeCell Production, Value, Price, Gross Margin 2015-2020Table CBR ProfileTable CBR Production, Value, Price, Gross Margin 2015-2020Table Cryo Stemcell ProfileTable Cryo Stemcell Production, Value, Price, Gross Margin 2015-2020Figure Global Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Global Stem Cell Banking Revenue ($) and Growth (2015-2020)Table Global Stem Cell Banking Sales by Regions (2015-2020)Table Global Stem Cell Banking Sales Market Share by Regions (2015-2020)Table Global Stem Cell Banking Revenue ($) by Regions (2015-2020)Table Global Stem Cell Banking Revenue Market Share by Regions (2015-2020)Table Global Stem Cell Banking Revenue Market Share by Regions in 2015Table Global Stem Cell Banking Revenue Market Share by Regions in 2019Figure North America Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Europe Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Asia-Pacific Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Middle East and Africa Stem Cell Banking Sales and Growth Rate (2015-2020)Figure South America Stem Cell Banking Sales and Growth Rate (2015-2020)Figure North America Stem Cell Banking Revenue ($) and Growth (2015-2020)Table North America Stem Cell Banking Sales by Countries (2015-2020)Table North America Stem Cell Banking Sales Market Share by Countries (2015-2020)Figure North America Stem Cell Banking Sales Market Share by Countries in 2015Figure North America Stem Cell Banking Sales Market Share by Countries in 2019Table North America Stem Cell Banking Revenue ($) by Countries (2015-2020)Table North America Stem Cell Banking Revenue Market Share by Countries (2015-2020)Figure North America Stem Cell Banking Revenue Market Share by Countries in 2015Figure North America Stem Cell Banking Revenue Market Share by Countries in 2019Figure United States Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Canada Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Mexico Stem Cell Banking Sales and Growth (2015-2020)Figure Europe Stem Cell Banking Revenue ($) Growth (2015-2020)Table Europe Stem Cell Banking Sales by Countries (2015-2020)Table Europe Stem Cell Banking Sales Market Share by Countries (2015-2020)Figure Europe Stem Cell Banking Sales Market Share by Countries in 2015Figure Europe Stem Cell Banking Sales Market Share by Countries in 2019Table Europe Stem Cell Banking Revenue ($) by Countries (2015-2020)Table Europe Stem Cell Banking Revenue Market Share by Countries (2015-2020)Figure Europe Stem Cell Banking Revenue Market Share by Countries in 2015Figure Europe Stem Cell Banking Revenue Market Share by Countries in 2019Figure Germany Stem Cell Banking Sales and Growth Rate (2015-2020)Figure UK Stem Cell Banking Sales and Growth Rate (2015-2020)Figure France Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Italy Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Spain Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Russia Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Asia-Pacific Stem Cell Banking Revenue ($) and Growth (2015-2020)Table Asia-Pacific Stem Cell Banking Sales by Countries (2015-2020)Table Asia-Pacific Stem Cell Banking Sales Market Share by Countries (2015-2020)Figure Asia-Pacific Stem Cell Banking Sales Market Share by Countries in 2015Figure Asia-Pacific Stem Cell Banking Sales Market Share by Countries in 2019Table Asia-Pacific Stem Cell Banking Revenue ($) by Countries (2015-2020)Table Asia-Pacific Stem Cell Banking Revenue Market Share by Countries (2015-2020)Figure Asia-Pacific Stem Cell Banking Revenue Market Share by Countries in 2015Figure Asia-Pacific Stem Cell Banking Revenue Market Share by Countries in 2019Figure China Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Japan Stem Cell Banking Sales and Growth Rate (2015-2020)Figure South Korea Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Australia Stem Cell Banking Sales and Growth Rate (2015-2020)Figure India Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Southeast Asia Stem Cell Banking Sales and Growth Rate (2015-2020)Figure Middle East and Africa Stem Cell Banking Revenue ($) and Growth (2015-2020)continue
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NOTE: Our report does take into account the impact of coronavirus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.
As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.
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Impact Of Covid-19 on Stem Cell Banking Market 2020 Industry Challenges, by Key Players, Types, Applications, Countries, Market Size, Forecast to 2026...
Protective protein could help keep blood young and healthy – New Atlas
A new study led by the University of Edinburgh and Queen Mary University of London has identified a protein that plays a crucial role in protecting the bodys blood stem cells from damage during infection, a finding that could lead to new ways to slow down the aging process.
Hematopoietic stem cells (HSCs) are found in bone marrow, and from there they produce other blood and immune cells. When an infection strikes the body, HSCs are known to ramp up production to fight it off but thats raised some questions for scientists in the past. In particular, how do they protect themselves from damage while working overtime?
We know that inflammatory pathways induced by infection force blood stem cells to rapidly produce immune cells to help combat infections, says Kamil Kranc, corresponding author of the study. However, these pathways can eventually exhaust stem cells or cause their premature aging, and it is important to understand how this can be stopped.
In the new study, the researchers identified a protein called YTHDF2 that seems to be responsible for this important job. When an infection arises, the HSCs produce far more immune cells, but at the same time that triggers inflammatory processes that can damage the stem cells. The study found that the YTHDF2 protein regulates genes that control those inflammatory processes, protecting the stem cells from premature aging.
To investigate the role of YTHDF2, the team engineered mice to be deficient in the protein, then administered a chemical that acts like a viral infection. Sure enough, the mices HSCs appeared to suffer chronic inflammation, altering the production of different blood cell types. Interestingly, the blood of these young animals began to resemble that of much older mice.
The new study seems to agree with previous reports that blood transfusions from young animals to older ones can improve the health of the recipient, and even slow the progression of diseases like Alzheimer's. As such, the team says that future work could investigate whether manipulating levels of YTHDF2 may be a potential anti-aging treatment.
The research was published in the Journal of Experimental Medicine.
Source: University of Edinburgh
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Protective protein could help keep blood young and healthy - New Atlas
Inflammation, Bone Healing and Osteonecrosis: From Bedside to Bench | JIR – Dove Medical Press
Stuart B Goodman,1,2 Masahiro Maruyama1
1Departments of Orthopaedic Surgery, Stanford University, Stanford, CA, USA; 2Departments of Bioengineering, Stanford University, Stanford, CA, USA
Correspondence: Stuart B GoodmanDepartments of Orthopaedic Surgery, Stanford University, 450 Broadway Street, Redwood City, CA 94063, USATel +1-650-721-7662Fax +1-650-721-3470Email goodbone@stanford.edu
Abstract: Osteonecrosis of the epiphyseal and metaphyseal regions of major weight-bearing bones of the extremities is a condition that is associated with local death of bone cells and marrow in the afflicted compartment. Chronic inflammation is a prominent feature of osteonecrosis. If the persistent inflammation is not resolved, this process will result in progressive collapse and subsequent degenerative arthritis. In the pre-collapse stage of osteonecrosis, attempt at joint preservation rather than joint replacement in this younger population with osteonecrosis is a major clinical objective. In this regard, core decompression, with/without local injection of bone marrow aspirate concentrate (BMAC), is an accepted and evidence-based method to help arrest the progression and improve the outcome of early-stage osteonecrosis. However, some patients do not respond favorably to this treatment. Thus, it is prudent to consider strategies to mitigate chronic inflammation concurrent with addressing the deficiencies in osteogenesis and vasculogenesis in order to save the affected joint. Interestingly, the processes of inflammation, osteonecrosis, and bone healing are highly inter-related. Therefore, modulating the biological processes and crosstalk among cells of the innate immune system, the mesenchymal stem cell-osteoblast lineage and others are important to providing the local microenvironment for resolution of inflammation and subsequent repair. This review summarizes the clinical and biologic principles associated with osteonecrosis and provides potential cutting-end strategies for modulating chronic inflammation and facilitating osteogenesis and vasculogenesis using local interventions. Although these studies are still in the preclinical stages, it is hoped that safe, efficacious, and cost-effective interventions will be developed to save the hosts natural joint.
Keywords: chronic inflammation, osteonecrosis, osteogenesis, vasculogenesis, bone healing, inflammation
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.
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Inflammation, Bone Healing and Osteonecrosis: From Bedside to Bench | JIR - Dove Medical Press
Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials – Salamanca Press
NEW YORK, Nov. 11, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today announced that it will host a CD33 program update featuring two key opinion leaders (KOLs) today, November 11th at 4:15 PM ET. The event will feature KOLs Dr. Ehab Atallah from the Medical College of Wisconsin, the senior investigator of the Actimab-A CLAG-M combination trial and Dr. Gary Schiller from the University of California Los Angeles Health, the principal investigator for the Actimab-A venetoclax combination trial as well as members of Actinium's management team. Both KOL's will review data that was included in abstracts accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting. They will also provide their perspectives on the treatment landscape and medical need each trial potentially addresses.
Actimab-A AML Combinations Update Call DetailsWebcast link:https://ir.actiniumpharma.com/presentations-webinarsDate: November 11, 2020Time: 4:15 PM ET
Dr. Ehab Atallah, MD, is a Professor of Medicine and Section Head of Hematological Malignancies at the Medical College of Wisconsin Division of Hematology and Oncology, specializing in leukemia and myelodysplastic syndromes at Froedtert Hospital. Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort. Further, 83% of patients (10/12) who received 3 or fewer prior lines of treatment achieved CR or CRi. Notably, 70% of CR/CRi patients (7/10) were MRD negative indicating a deep remission with no detectable disease. Dr. Atallah will also discuss the trial data in the context of data available for other treatment options, including recently approved and novel agents in development, in the fit R/R AML population.
Dr. Gary Schiller, MD, is the Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology at UCLA. Dr. Schiller, a well-published clinical investigator in acute and chronic leukemias and other hematologic malignancies, is the principal investigator on the Phase 1/2 clinical trial of Actimab-A and venetoclax. Dr. Schiller will discuss the lack of viable treatment options for R/R AML and the available opportunity for combination regimens such as Actimab-A plus venetoclax. Last week, the company announced that first-in-human data in this combination trial had been accepted for poster presentation at ASH in December. The trial is in the dose escalation phase with proof of concept data expected in 2021.
CD33 Program ASH Abstract Links
Oral Presentation Title: A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AMLPublication Number: 165Link: https://ash.confex.com/ash/2020/webprogram/Paper137218.html
Poster Title: Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II StudyPublication Number: 2875Link: https://ash.confex.com/ash/2020/webprogram/Paper141132.html
About Actinium's CD33 Program
Actinium's CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred and twenty-five treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant.Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.
About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contacts:
Investors:Clayton RobertsonActinium Pharmaceuticals, Inc.crobertson@actiniumpharma.com
Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 430-7578
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Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials - Salamanca Press
TaiGen Partners with GPCR to develop Burixafor & Taigexyn(R) – PRNewswire
TAIPEI, Nov. 9, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that they have signed an exclusive agreement with GPCR Therapeutics, Inc. ("GPCR"), a leading Korean biotechnology company, for the continued development of Burixafor worldwide and the commercialization of Taigexyn (nemonoxacin) in South Korea.
Burixafor is a highly potent CXCR4 inhibitor currently under clinical development. It can be used as a stem cell mobilizer for hematopoietic stem cell transplantation and a chemosensitizer in hematological and solid tumors. It can also be used for stem cell collection in healthy individuals for personalized regenerative medicine. Taigexyn is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria.
Under the terms of the agreement, GPCR Therapeutics will be wholly responsible for the development, registration, and commercialization of Taigexyn in S. Korea and Burixafor worldwide. Apart from upfront fees, TaiGen will receive shares of GPCR Therapeutics as well as future milestone and royalty payments.
GPCR Therapeutics is a world leader in the field of GPCR heteromer science and hasproprietary expertise and technology applicable to the development of this class of anti-cancer targets. CXCR4 antagonism is a well-accepted avenue towards cancer therapy and GPCR Therapeutics is well experienced and possesses the necessary know-how to develop Burixafor in the oncology field.
Dongseung Seen, CEO of GPCR Therapeutics, said, "This collaboration with TaiGen, which is a leading biotech company engaged in innovative molecular-based platforms with strong R&D capabilities, will lead to a long-term strategic and productive partnership. Further, it is our goal that our work together will position us to be a pre-eminent developer of anti-CXCR4 oncology drugs."
Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "This agreement and collaboration with GPCR is a tremendous progress in the continued development of Burixafor. Through the collaboration with GPCR Therapeutics, a novel and effective treatment for cancer patients possessing CXCR4 heteromers is on the horizon while a highly effective antibiotic will enter the S. Korea market to address their unmet medical needs in the near future."
About Burixafor
A stem cell mobilizer, Burixafor, is TaiGen's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy.
About Taigexyn
Taigexyn is a novel non-fluorinated quinolone available in both oral and intravenous formulations. The oral formulation of Taigexyn have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. TaiGen partnered with Zhejiang Medicaine Co., Holding Distribution, R-Pharm of Russia, Productos Cientficos S.A. de C.V., Luminarie Canada Inc. and GPCR Therapeutics, Inc. in 36 countries worldwide. In addition to the oral formulation, TaiGen granted NDA approval for intravenous formulation in Taiwan and is going to obtain the market approval in mainland China.
About GPCR Therapeutics, Inc.
Based in Seoul, S. Korea, GPCR Therapeutics is a biopharmaceutical company developing drugs based on the novel science of GPCR (G Protein-Coupled Receptor) heteromers. GPCR Therapeutics is specifically focused on the development of cancer therapeutics with a precision oncology approach.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn and Burixafor, TaiGen has two other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and is granted IND approval by FDA in the U.S., and Furaprevir is currently in Phase 3 clinical development.
SOURCE TaiGen
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TaiGen Partners with GPCR to develop Burixafor & Taigexyn(R) - PRNewswire
Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to…
Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205
About Regenerative Medicine Advanced Therapy (RMAT) DesignationEstablished under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.
About HDT-AHCT High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.
About SRRT Consequences of Diffuse Injury to the Organ Vascular NichesThe human body is capable of renewing, healing and restoring organs.For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells.When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age.HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected.Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury.The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis.HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver.Collectively, these complications are known as severe regimen-related toxicities or SRRT.SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.
About AB205AB-205 is a first-in-class engineered cell therapy consisting of proprietary 'universal' E-CEL (human engineered cord endothelial) cells.The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient's own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT.By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.
About CIRMThe California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions.With over 300 active stem cell programs in their portfolio, CIRM is the world's largest institution dedicated to stem cell research. For more information, visit http://www.cirm.ca.gov.
About Angiocrine Bioscience Inc.Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body.Based on its novel and proprietary E-CEL platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases.A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT.This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA.In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.
For additional information, please contact:
Angiocrine Bioscience, Inc.John R. Jaskowiak(877) 784-8496[emailprotected]
SOURCE Angiocrine Bioscience, Inc.
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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to...
Alpha Mannosidosis Market to Showcase 9.9% CAGR during 2019-2027 and Reach US$18.7 Mn Valuation by 2027, Says TMR – PRNewswire
ALBANY, N.Y., Nov. 11, 2020 /PRNewswire/ --Transparency Market Research has now published a new research report that offers a detailed information about the global alpha mannosidosis market. The research report tries to offer meaningful and actionable insights about the key segments, prominent growth drivers, restraining factors, geographical outlook, and the current situation of the vendor landscape of the global market.
According the research report, the global alpha mannosidosis market was initially valued at US$7.6 Mn in 2018. The research report projects the market to grow at a strong CAGR of 9.9% over the course of the given forecast period ranging from 2019 to 2027. Given the rate of growth, the market is expected to reach a valuation worth US$18.7 Mn by 2027.
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Explore a report with detailed research, incisive insights, and in-depth country levels estimations. Gain business intelligence on global Alpha Mannosidosis Market (Treatment - Bone Marrow Transplant (BMT) and Enzyme Replacement Therapy (ERT); Indication - Type I, Type II and Type III; End Users - Hospitals and Specialty Clinics) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/2501
Global Alpha Mannosidosis Market Key Driving Factors
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Global Alpha Mannosidosis Competitive Landscape
The global alpha mannosidosis market presently has a single company that markets its product. Zymenex is the industry leader in the global market and has been concentrating on research and development activities to produce more effective therapeutics. The competitive landscape of the global alpha mannosidosis is projected to expand in coming years of the forecast period as other pharma companies with new drugs in pipeline get their approvals.
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Alcoholic Hepatitis Therapeutics Market: Research and development activities have revealed that modification of gut microbiota and products related to it, including nutritional intervention, increasing steroid sensitivity, lipopolysaccharide, immune modulation, and epigenetic modification of liver damage caused by alcohol are some of the groundbreaking avenues in the alcoholic hepatitis therapeutics market that are expected to offer tremendous promise during the forecast period.
Anthelmintic Drugs Market: Companies in the anthelmintic drugs market are increasing their research efforts to study the biologically active substances of medicinal plants that possess drug-like properties and hold promising potentials for the treatment of intestinal parasitic nematodes in human as well as animals. As such, medicinal plant-derived drugs, such as artemether, tiopropium and galantamine are generating revenue streams for pharmaceutical companies.
Hydrocortisone Market: Companies in the hydrocortisone market are introducing medicines that do not require a prescription. For instance, in May 2019, Aflofarm a supplier of Over the Counter drugs (OTC) and medical devices, announced the launch of Maxicortan, a medicine with double dose of hydrocortisone that can be applied locally on skin inflammations and caters to individuals with atopic dermatitis.
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Regenerative Medicine Market with Report In Depth Industry Analysis on Trends, Growth, Opportunities and Forecast till 2026 – Illadel Graff Supply
The latest report on Regenerative Medicine market collated by Market Study Report, LLC, delivers facts and numbers regarding the market size, geographical landscape and profit forecast of the Regenerative Medicine market. In addition, the report focuses on major obstacles and the latest growth plans adopted by leading companies in this business.
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The Regenerative Medicine Market is anticipated to reach over USD 79.23 billion by 2026 according to a new research. In 2017, the cell therapy dominated the global Regenerative Medicine market, in terms of revenue. North America is expected to be the leading contributor to the global market revenue in 2017.
The regenerative medicine market is primarily driven by the increasing number of individuals suffering from cancer, rising need to monitor and treating these chronic diseases in the limited time. Furthermore, stringent government policies, proper reimbursement policies, and increasing government healthcare expenditure for developing healthcare infrastructure to also boost the market growth in coming years. Also, rising number of organ transplantation, and increasing number of products in pipeline that are waiting for approval create major opportunity for the regenerative medicines in the coming years. However, some of the ethical and religious concerns for the use of stem cells, and lack of proper regulatory for the approval of various drugs would impede the market growth during the forecast period.
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North America generated the highest revenue in the Regenerative Medicine market in 2017, and is expected to be the leading region globally during the forecast period. Increasing number of patients suffering from chronic diseases, improved healthcare infrastructure and health facilities, accessibility of healthcare facilities, are the primary factors driving the market growth in this region. While, Asia Pacific to be the fastest growing region in the coming years. The growth in this region is majorly attributed to the developing healthcare infrastructure of the countries like India, & China, and rising awareness for the use of regenerative medicines as an effective treatment option for chronic diseases.
Regenerative medicine is a branch of medicine that regrows, and repairs the damaged cells in the human body. These medicines include the use of stem cells, tissue engineering, that further helps in developing new organ that function smoothly. These medicines have the caliber of developing an entire organ as these cells are multipotent. The cells are majorly isolated from bone marrow, and umbilical cord blood.
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The key players operating in the Regenerative Medicine market include Organogenesis Inc., Vericel Corporation, Osiris Therapeutics, Inc., Stryker Corporation, and NuVasive, Inc., Medtronic Plc., Acelity, Cook Biotech Inc., Integra LifeSciences, and C.R. Bard. These companies launch new products and collaborate with other market leaders to innovate and launch new products to meet the increasing needs and requirements of consumers.
Regenerative Medicine Market share byMajor regions included:
United StatesNorth AmericaAsia PacificEuropeMiddle East & Africa
Table of Contents
1. Overview and Scope1.1. Research goal & scope1.2. Research assumptions1.3. Research Methodology1.3.1. Primary data sources1.3.2. Secondary data sources1.4. Key take-away1.5. Stakeholders2. Executive Summary2.1. Market Definition2.2. Market Segmentation3. Regenerative Medicine Market Insights3.1. Regenerative Medicine Industry snapshot3.2. Regenerative Medicine Ecosystem analysis3.3. Regenerative Medicine Market Dynamics3.3.1. Regenerative Medicine Market Forces3.3.1.1. Regenerative Medicine Market Driver Analysis3.3.1.2. Regenerative Medicine Market Restraint/Challenges analysis3.3.1.3. Regenerative Medicine Market Opportunity Analysis3.4. Industry analysis Porters five force3.4.1. Bargaining power of supplier3.4.2. Bargaining power of buyer3.4.3. Threat of substitute3.4.4. Threat of new entrant3.4.5. Degree of competition3.5. Regenerative Medicine Market PEST Analysis3.6. Regenerative Medicine Market Value Chain Analysis3.7. Regenerative Medicine Industry Trends3.8. Competitive Ranking Analysis4. Regenerative Medicine Market Size and Forecast by Therapy Type, 2018-20264.1. Key Findings4.2. Tissue engineering4.3. Cell Therapy4.4. Immunotherapy4.5. Gene Therapy5. Regenerative Medicine Market Size and Forecast by Product Type, 2018-20265.1. Key Findings5.2. Acellular Products5.3. Cellular Products
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California Proposition 14 is about pikuach nefesh heres why – Forward
Only two decades ago, stem cell therapy was highly regulated in the United States and other countries but it was well underway in Hadassah Hospitals labs in Jerusalem. Never would we have imagined that the US expansion of one of the key clinical trials conducted in our labs in Israel would be later funded by Californias Stem Cell Institute.
In 2004, California had the foresight to advance this critical area of research, and Hadassah advocates played a major role in the passing of an unprecedented statewide ballot initiative that authorized state funding for stem cell research. This marked the passage of Proposition 71 in 2004.
Fast forward to today. Hadassahs commitment to stem cell research led the Californians for Stem Cell, Research, Treatments and Cures Initiative effort in 2020 to reach out for help with their grassroots effort to qualify the latest stem cell funding initiative for the November ballot. It qualified with your help, and I hope that in a few short weeks well be celebrating the passage of Proposition 14, which will provide $5.5 billion to help accelerate development of treatments and cures for life-threatening diseases and conditions.
The power of stem cells is mind-blowing: We are able to use these cells to replace damaged or diseased tissue, and in this way, treatments or cures for diseases like age-related macular degeneration, ALS, MS, Parkinsons, Alzheimers and diabetes could be a reality in the foreseeable future.
I come to this subject from a place of personal sorrow.
I watched my father-in-law, Irv, suffer for 12 and a half years with ALS, a man I loved as if he were my own father. He fought and fought, he made every minute of his battle meaningful, soaking as much life as he could, until he couldnt. Irv is the reason why I became involved in Hadassah because of their cutting-edge medical research and he is the reason that Im writing to you now.
Today, Hadassah is doing incredible things in stem cell research, and the stunning results of their clinical trials have riveted the worldwide medical community.
Of course, the research most personal to me is the ALS research. Hadassah researchers conducted the worlds first clinical trial using the patients own bone marrow stem cells to treat ALS.Pikuach nefesh, the preservation of life, is the most important obligation in Judaism, and the one that drives Hadassah. With the potential of stem research, we have the ability to save millions of lives throughout the world.
And, with the promise of stem cells, we can accelerate the development of treatments and cures for life-threatening diseases and conditions that affect someone in nearly half of all California families.
I believe that stem cell research is going to allow our children to look at the major diseases that plague our modern world the way we now view polio.That potential will not reveal itself on its own, nor did it with polio. It took decades of research and funding for a polio vaccine to be fully developed, tested and made available widely.
There are no medical miracles. Medical advancement happens because of research. Research takes will, knowledge, chutzpah and, of course, money. The path to get a therapy approved by the Food and Drug Administration can take 12 to 15 years, requires thousands of patients for clinical trials and costs billions of dollars. from life-saving vaccines, to pioneering cancer treatments, to the sequencing of the human genome.w When research stalls for lack of funding, opportunities are missed. Promising avenues go unexplored.
The passage of Proposition 14 would help to overcome those hurdles and create a streamlined process that delivers much-needed treatments to patients who have few options. How amazing would it be to be part of making medical history.I am so proud to be a member of Hadassah, which is not only leading the way in stem cell research but also doing its research in service to humanity. Together, we can make medical discoveries happen and continue to set the pace for the worldwide medical community.
I wish that my father-in-law was here to give you his final thumbs up.
Stacey Dorenfeld is the National State Advocacy Co-Chair and the Hadassah Southern California Advocacy Chair.
The views and opinions expressed in this article are the authors own and do not necessarily reflect those of the Forward.
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California Proposition 14 is about pikuach nefesh heres why - Forward
Cynata looking to revolutionise stem cell therapy – The West Australian
Ongoing studies of Cynata Therapeutics Cymerus stem cell products are beginning to reveal a wide range of commercial possibilities for the ASX-listed companys cutting edge biotechnology that it is looking to apply to a multitude of ailments from the treatment of osteoarthritis and heart attacks through to COVID-19.
In its most advanced trials to date, Cynata will soon embark on a Phase 3 trial of its CYP-004 product, the companys mesenchymal stem cell or MSC product developed to treat osteoarthritis. The 448 person trial is being sponsored by The University of Sydney and will be funded by a project grant from the Australian Government National Health and Medical Research Council.
The company is also progressing on multiple other fronts developing a range of Cymerus MSC therapeutics with the CYP-001 product being another lead candidate. CYP-001 is being developed to treat acute graft-versus-host disease, or GVHD an affliction suffered by bone marrow transplant recipients. GVHD can develop from donated bone marrow that does not take well to a recipients body which triggers an immune response, attacking the host.
Presently, GVHD is treated with steroid therapy however sufferers tend to have a very low survival rate, with less than 20 per cent of patients living for more than two years and few alternate treatment pathways are available.
This looks set to change following Phase 1 trial of Cynatas CYP-001 product on a cohort of patients which saw the survival rate of sufferers of GVHD triple to 60 per cent over a two-year period. The company is now moving CYP-001 into Phase 2 testing and towards commercialisation with partner and shareholder, Fujifilm Corporation.
The matchup with the Japanese-based multi-national is already paying dividends with Cynata receiving an upfront US$3 million payment with further staged payments and royalties to follow in a licensing deal potentially worth more than US$50 million in the longer term.
Stem cells are the building blocks of the human body - essentially the cells from which all other cells are derived and under the right conditions, they can divide to produce more cells sometimes known as Daughter cells. These Daughter cells can become new stem cells or more specialised cells such as blood, bone or even the cells that make up brain or heart tissue.
When appropriately manipulated, stem cells have the potential to treat a range of diseases and aid in the healing and recovery of patients suffering both disease and trauma.
There are a limited number of sources of stem cells - embryonic stem cells, perinatal stem cells and adult stem cells.
Embryonic stem cells are thought to be the most useful and versatile but only harvestable in very small quantities. Perinatal stem cells found in amniotic fluid and umbilical cord blood are also only harvestable in limited quantities although their potential is yet to be fully understood.
Adult stem cells, found in bone marrow or fat, were previously thought to be only useful in producing a limited range of specialised cells with multiple donors required to generate practical amounts of therapeutical medicines.
However, ongoing research shows that by utilising a form of genetic reprogramming, mature cells can be re-programmed to behave like embryonic stem cells. These manipulated cells are called induced pluripotent stem cells, or iPSCs which is where Cynatas Cymerus technology comes into the picture.
Cynatas proprietary Cymerus technology uses iPSCs and a precursor cell called a mesenchymoangioblast to manufacture MSC therapies at a commercial scale without the need for multiple donors. This is where the Cymerus platform diverges from similar therapies, doing away with the need for multiple donors and overcoming a bottleneck in the generation of its product.
Other Cynata MSC products in development include a therapy to assist in the treatment and recovery of heart attacks, which is also showing promise according to the company. Another Cynata product undergoing pre-clinical trials with potential application in the treatment of lung disease is idiopathic pulmonary fibrosis, or IPF. Cynatas research in lung diseases has an unexpected spin-off in that its MSCs may assist in a patients recovery of COVID-19 according to the company. This application is being pursued in a clinical trial in COVID-19 patients presently being conducted in NSW.
These latest results with Cymerus MSCs add to the large body of evidence on the potency of these cells and their potential utility in treating a wide range of devastating diseases. IPF represents an enormous unmet medical need, as existing treatment options have only modest effects on disease progression and survival rates.
Cynatas is now modelling potential MSC therapies to treat various other afflictions too including critical limb ischemia, asthma, sepsis, cytokine release syndrome and diabetic wounds.
In the world of biotechnology, you really only have to produce one winner to attract a longing stare from the big biotechs who can swallow you whole with their massive cheque books with a range of targets and opportunities in its armoury that look to be developing well, dont be surprised if Cynata eventually disappears under the giant footprint of one of the big biotechs.
Is your ASX listed company doing something interesting? Contact: matt.birney@wanews.com.au
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Cynata looking to revolutionise stem cell therapy - The West Australian
BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization – PRNewswire
TEL AVIV, Israel, Oct. 30, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.
At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.
In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.
"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."
The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy LifeSci Advisors, LLC +1-212-915-2564 [emailprotected]
or
Moran Meir LifeSci Advisors, LLC +972-54-476-4945 [emailprotected]
SOURCE BioLineRx Ltd.
Orchard Therapeutics’ gene therapy Strimvelis linked to a leukemia case – FiercePharma
The potential of gene therapies as cures for some hard-to-treat genetic diseases can be very attractive. But one such product is now suspected of causing a serious safety problem.
Friday, Orchard Therapeutics said its Strimvelis treatment, approved by European authorities in 2016 to treatthe rare inherited condition ADA-SCID, has been linked to a patients leukemia.
Preliminary findings suggest this diagnosis may be attributable to an insertional event related to treatment with Strimvelis, the company said. Its now investigating whether theres indeed a causal relationship.
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Since its 2016 EU approvalwhen it was owned by original developer GlaxoSmithKlineonly 16 patients have been treated with Stimvelis. The patient who developed leukemia had apparently been treated under a GSK compassionate use program in 2016.
No more patients will get the therapy before the investigation is complete, Orchard said. The drug was never approved in the U.S.
ADA-SCIDis a condition marked by a mutation in the gene making the adenosine deaminase (ADA) enzyme, which is essential for maintaining normal white blood cells. ADA-SCID patients, with a dysfunctional immune system, have less than two years to live without effective intervention.
RELATED:Orchard licenses gene therapy tech from GSK
Strimvelis, originally developed by GSK and bought by Orchard in 2018, offers an option for patients who cant find a matched stem cell donor. It works by editing the patients own hematopoietic stem cells with the functional ADA gene. The cells arethen transferred back into the patient's bone marrow to mature and produce the normal ADA protein.
The therapy uses a gammaretrovirus as the vector to carry the gene. Problem is, retrovirus can incorporate their own genetic information into the human genome, causing unintended changes that can give rise to cancer. It is a known risk factor of gammaretroviral vector-based gene therapy and has been described as one of the important potential risks for Strimvelis in its EU approval.
Besides Strimvelis, Orchard is also developing OTL-101, which uses a lentivirus to insert a functional copy of the ADA gene into a patients cells. The drug is currently undergoing a registrational trial and has won breakthrough and orphan drug designations from the FDA.
All the gene therapy candidates in Orchards pipeline use lentiviral vectors that have been specifically designed to avoid insertional oncogenesis after administration, Orchard said, adding that no dangerous gene insertion has been reported around lentiviral vector-based stem cell gene therapy in any indication.
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Orchard Therapeutics' gene therapy Strimvelis linked to a leukemia case - FiercePharma
US biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shown positive results in severely ill…
U.S. biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shownpositive results inseverely ill patients
Vancouver, WACytoDyn Inc. (CytoDyn) a late-stage biotechnology companydeveloping leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announcedit is currently accepting only 155 more candidates across the country for its Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19.
CytoDyn is currently enrolling COVID-19 patients in its Phase 2b/3 clinical trial in at least 13 hospitals in nine states (California, Georgia, Massachusetts, New Jersey, New York, North Carolina, Ohio, Oregon and Texas). Please visit the Companys website atwww.cytodyn.com. The sites currently enrolling patients are listed on the home page under Clinical Trial Enrollment, then click on COVID-19 Severe or Critical in the drop-down screen. Please visit the website frequently, as the list of hospitals is updated on a regular basis.
CytoDyn has already enrolled 235 patients in its trial, and the Data Safety Monitoring Committee (DSMC) recently recommended CytoDyn continue its study without modification to achieve its primary endpoint, based on the results the DSMC observed so far.
The DSMC also added that it will look at the unblinded data again, once an additional 58 patients are enrolled.
We are very encouraged the DSMC recommended we continue our trial without modification, said Nader Pourhassan, Ph.D., President and CEO of CytoDyn.We believe this result, combined with the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients, is an indicator of positive data.
Its our hope this means our study is not only proving to be safe, but effective. If it wasnt, the DSMC would have stopped our trial or requested modifications.But instead, the DSMC recommended we continue our study without modification, and indicated it would look at the unblinded data once we are 75% enrolled.This, to us, is a very strong signal of positive data, added Pourhassan.
The recovery of a young woman in California provides some hopeful evidence of the effectiveness of leronlimab, Pourhassan said. She had contracted COVID-19 and was in the hospital on a ventilator. Within 24 hours after receiving a single injection of leronlimab, the amount of oxygen she needed started to drop, and 2 days later, she was able to be removed from her ventilator and later, sent home. She believes our drug saved her life.
We are optimistic and look forward to the completion of our study, or possible early evaluation to warrant an Emergency Use Authorization (EUA) from the FDA, Pourhassan concluded.
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.
CytoDyn is currently enrolling patients in its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in at least 13 hospitals and clinics across the U.S., which are identified in this press release and on the Companys website under the Clinical Trial Enrollment section of the homepage.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, including for patients with COVID-19, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain emergency use authorization or regulatory approval for leronlimab for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results,(ii) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (iii) the market for, and marketability of, any product that is approved, (iv) the sufficiency of the Companys cash position, (v) the Companys ability to raise additional capital to fund its operations, (vi) the Companys ability to meet its debt obligations, if any, (vii) the Companys ability to enter into partnership or licensing arrangements with third parties, (viii) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (ix) the Companys ability to achieve approval of a marketable product, (x) the design, implementation and conduct of the Companys clinical trials, ((xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this release.
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Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? – SurvivorNet
How an Imaging Test Predicts Treatment Response
If youve already gone through a round of treatment for diffuse large B-cell lymphoma and it didnt work, or your cancer came back after treatment, your doctor might start talking to you about having an autologous stem cell transplant. This therapy involves getting high doses of chemotherapy to get rid of your cancer cells, followed by an infusion of stem cells taken from your blood or bone marrow before treatment, to replenish your bodys supply of healthy blood cells.
Related: What is Autologous Stem Cell Transplant?
A stem cell transplant can be a pretty grueling treatment that involves getting very high doses of chemotherapy, spending three to four weeks in the hospital, and enduring side effects like nausea, vomiting, mouth pain, infections, bleeding, and lung inflammation. And after all of that, you still may not get the results you want.
If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.
One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.
Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.
The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.
CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.
A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.
When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.
Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.
One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.
Learn more about SurvivorNet's rigorous medical review process.
Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More
Related: What is Autologous Stem Cell Transplant?
If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.
One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.
Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.
The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.
CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.
A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.
When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.
Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.
One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.
Learn more about SurvivorNet's rigorous medical review process.
Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More
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Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? - SurvivorNet
Stem Cell Banking Market to witness an impressive growth during the forecast pe – News by aeresearch
The latest Stem Cell Banking market research report offers a top to bottom analysis of this business sphere in terms of potential industry size, supply chain, growth dynamics, opportunity analysis, and competitive landscape. Furthermore, it extends through abstracts on various industry segments, inclusive of a rundown of the business scenario across the various regional markets. Additionally, the study provide insights into to the impact of Covid-19 pandemic and recommends strategies that could maximize ROI amid these uncertain times.
Key areas covered in the Covid-19 impact assessment:
An overview of the regional analysis:
Request Sample Copy of this Report @ https://www.aeresearch.net/request-sample/341604
Other important inclusions in the Stem Cell Banking market report:
Key Questions Answered in The Report:
What will the Stem Cell Banking market growth rate?
What are the key factors driving the global Stem Cell Banking market?
Who are the key manufacturers in Stem Cell Banking market space?
What are the market opportunities and overview of the Stem Cell Banking market?
What are sales, revenue, and price analysis of top manufacturers of Stem Cell Banking market?
What are the Stem Cell Banking market opportunities and threats faced by the vendors in the global Stem Cell Banking Industry?
What are sales, revenue, and price analysis by types and applications of Stem Cell Banking Industry?
Request Customization on This Report @ https://www.aeresearch.net/request-for-customization/341604
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Stem Cell Banking Market to witness an impressive growth during the forecast pe - News by aeresearch
NexImmune Establishes Research Initiative with City of Hope to Focus on Novel Immunotherapeutic Approaches to Acute Myeloid Leukemia – Stockhouse
GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- NexImmune, a clinical-stage biotechnology company developing unique non-genetically-engineered T cell immunotherapies, announced today that it has signed a research initiative related to its AIM nanoparticle technology with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases.
City of Hope is a participating clinical site in the ongoing Phase 1/2 study of NEXI-001. The cancer center will leverage both patient samples from the ongoing NexImmune Phase 1/2 clinical study of NEXI-001 in acute myeloid leukemia (AML) patients with relapsed disease after allogeneic stem cell transplantation and the center’s tumor repository bank of primary leukemia samples, one of the largest collections in the world, to drive the research.
NEXI-001 is a cellular product candidate that contains populations of naturally occurring CD8+ T cells directed against multiple antigen targets for AML, and it is the first clinical product generated by the Company’s AIM nanoparticle technology.
NexImmune has developed a unique and versatile technology platform that lends itself very effectively to important areas of ongoing research in the field of AML,” said Guido Marcucci, M.D., Chair and Professor with City of Hope’s Department of Hematologic Malignancies Translational Science. Our collective goal is to translate future research findings into new, more effective T cell immunotherapies to the benefit of these very difficult to treat patients.”
A key objective of the research will focus on the identification of new antigen targets that are expressed on both leukemic blasts as well as leukemic stem cells, and those which represent survival proteins to both. Once identified, these antigen targets will be loaded on NexImmune AIM-nanoparticles to expand antigen-specific CD8+ T cells, and evaluated in pre-clinical models for anti-tumor potency, tumor-specific killing, and response durability.
In addition, the research initiative will aim to further understand different mechanisms of tumor escape, such as tumor antigen and human leukocyte antigen (HLA) downregulation due to immune pressure.
Research between NexImmune and City of Hope will inform a scientific understanding of how the immune system can address certain tumor escape mechanisms to more effectively fight aggressive cancers like AML, and how this might be accomplished with NexImmune’s AIM technology and T cell products,” said Monzr Al Malki, M.D., Director of City of Hope’s Unrelated Donor BMT Program and Haploidentical Transplant Program and an Associate Clinical Professor with Department of Hematology and Hematopoietic Cell Transplantation. Based on our current clinical experience with this technology, we’re excited to learn what more this research will tell us.”
City of Hope is a world-class clinical research institution that has built one of the largest banks of leukemia samples in the world,” said Han Myint, M.D., NexImmune Chief Medical Officer. The depth of expertise that Drs. Marcucci, Al Malki and their team bring to this research initiative will help NexImmune continue to develop innovative products that can help patients with AML and other hard-to-treat cancers.”
City of Hope is a leader in bone marrow transplantation . More than 16,000 stem cell and bone marrow transplants have been performed at City of Hope, and more than 700 are performed annually. City of Hope’s BMT program is the only one in the nation that has had one-year survival above the expected rate for 15 consecutive years, based on analysis by the Center for International Blood and Marrow Transplant Research.
About NexImmune NexImmune is a clinical-stage biotechnology company developing unique approaches to T cell immunotherapies based on its proprietary Artificial Immune Modulation (AIM) technology. The AIM technology is designed to generate a targeted T cell-mediated immune response and is initially being developed as a cell therapy for the treatment of hematologic cancers. AIM nanoparticles (AIM-np) act as synthetic dendritic cells to deliver immune-specific signals to targeted T cells and can direct the activation or suppression of cell-mediated immunity. In cancer, AIM-expanded T cells have demonstrated best-in-class anti-tumor properties as characterized by in vitro analysis, including a unique combination of anti-tumor potency, antigen target-specific killing, and long-term T cell persistence. The modular design of the AIM platform enables rapid expansion across multiple therapeutic areas, with both cell therapy and injectable products.
NexImmune’s two lead T cell therapy programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to > 3 prior lines of therapy, respectively. The Company’s pipeline also has additional preclinical programs, including cell therapy and injectable product candidates, for the treatment of oncology, autoimmune disorders, and infectious diseases.
For more information, visit http://www.neximmune.com.
Media Contact: Mike Beyer Sam Brown Inc. Healthcare Communications 312-961-2502 mikebeyer@sambrown.com
Investor Contact: Chad Rubin Solebury Trout +1-646-378-2947 crubin@soleburytrout.com
Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button – Royal Sutton News
Global Hematopoietic Stem Cell Transplantation Market Report from AMA Research highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.
Major Players in This Report Include,
Gilead Sciences Inc. (United States), Thermo Fisher Scientific (United States), PromoCell (Germany), CellGenix Technologie Transfer GmbH (Germany), Cesca Therapeutics Inc.(United States), R&D Systems (United States), Genlantis (United States), Lonza Group Ltd.(Switzerland), TiGenix N.V.(Belgium), ScienCell Research Laboratories (United States), Regen Biopharma Inc. (United States), China Cord Blood Corp (Hong Kong) and CBR Systems Inc. (United States).
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Analyst at AMA have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Hematopoietic Stem Cell Transplantation Market along with tables and graphs related to various country and segments showcasing impact on growth trends.
Definition
Despite the increasing availability of smart antineoplastic therapies in recent years, Hematopoietic stem cell transplantation (HSCT) remains an optimal treatment modality for many hematologic malignancies. HSCT is one of a range of therapeutic options which is available to patients suffering from various diseases. It is a widely accepted treatment for many life-threatening diseases. The treatment is available to patients who suffer from refractory or relapsing neoplastic disease and non-neoplastic genetic disorders, as well as from chronic bone marrow failure. Hematopoietic stem cells are young or immature blood cells which are found to be living in bone marrow. These blood cells when matures in bone marrow very few enters into bloodstream.
Global Hematopoietic Stem Cell Transplantation Market Report offers a detailed overview of this market and discusses the dominant factors affecting the growth of the market. The impact of Porters five armies on the market over the next few years has been discussed for a long time in this study. We will also forecast global market size and market outlook over the next few years.
Types of Products, Applications and Global Hematopoietic Stem Cell Transplantation Market Report Geographical Scope taken as the Main Parameter for Market Analysis. This Research Report Conducts an assessment of the industry chain supporting this market. It also provides accurate information on various aspects of this market, such as production capacity, available production capacity utilization, industrial policies affecting the manufacturing chain and market growth.
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The Hematopoietic Stem Cell Transplantation market study is being classified by Type, Applicationsand major geographies with country level break-up that includes South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).
The report concludes with in-depth details on the business operations and financial structure of leading vendors in the Global Hematopoietic Stem Cell Transplantation market report, Overview of Key trends in the past and present are in reports that are reported to be beneficial for companies looking for venture businesses in this market. Information about the various marketing channels and well-known distributors in this market was also provided here. This study serves as a rich guide for established players and new players in this market.
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Current Scenario Analysis for Decision Framework
Key Strategic Developments in Hematopoietic Stem Cell Transplantation Market:
The research includes the key strategic activities such as Research & Development (R&D) initiatives, Merger & Acquisition (M&A) completed, agreements, new launches, collaborations, partnerships & (JV) Joint ventures, and regional growth of the key competitors operating in the market at global and regional scale to overcome current slowdown due to COVID-19.
Key Market Features in Global Hematopoietic Stem Cell Transplantation Market
The report highlights Hematopoietic Stem Cell Transplantation market features, including revenue size, weighted average regional price, capacity utilization rate, production rate, gross margins, consumption, import & export, demand & supply, cost bench-marking in Hematopoietic Stem Cell Transplantation market share and annualized growth rate (Y-o-Y) and Periodic CAGR.
Extracts from Table of Contents
Global Hematopoietic Stem Cell Transplantation Market Research Report
Chapter 1 Global Hematopoietic Stem Cell Transplantation Market Overview
Chapter 2 Global Economic Impact on Industry
Chapter 3 Global Market Competition by Manufacturers
Chapter 4 Global Revenue (Value, Volume*) by Region
Chapter 5 Global Supplies (Production), Consumption, Export, Import by Regions
Chapter 6 Global Revenue (Value, Volume*), Price* Trend by Type
Chapter 7 Global Market Analysis by Application
.continued
This report also analyzes the regulatory framework of the Global Markets Hematopoietic Stem Cell Transplantation Market Report to inform stakeholders about the various norms, regulations, this can have an impact. It also collects in-depth information from the detailed primary and secondary research techniques analyzed using the most efficient analysis tools. Based on the statistics gained from this systematic study, market research provides estimates for market participants and readers.
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Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button - Royal Sutton News
BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small…
DetailsCategory: Small MoleculesPublished on Friday, 30 October 2020 17:39Hits: 210
- Enrollment to cease immediately; topline data anticipated in H1 2021-
TEL AVIV, Israel I October 30, 2020 I BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.
At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.
In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.
"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."
The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn
SOURCE: BioLineRx
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BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small...
Study: Poverty Linked to Higher Risk of Death Among Children with Cancer Undergoing Stem Cell Transplantation – PRNewswire
WASHINGTON, Oct. 26, 2020 /PRNewswire/ --Despite the increasing use and promise of hematopoietic cell transplantation (HCT) as curative therapy for children with cancer and other life-threatening diseases, new research suggests that children transplanted for cancer are more likely to die from treatment-related complications if they live in poorer neighborhoods. The study, published today in the journal Blood, also found that having Medicaid versus private insurance, another marker of poverty, was associated with a higher chance of dying. Researchers say the results underscore the need to better understand and mitigate the effects of poverty and other social determinants of health on pediatric cancer care.
Hematopoietic cell transplantation, also called stem cell or bone marrow transplantation, is a treatment option for patients with blood cancers such as leukemia or lymphoma, as well as certain non-malignant conditions such as sickle cell disease or immunodeficiencies. It is only accessible at some medical centers. Together with radiation therapy or chemotherapy, HCT is designed to increase the chance of eliminating the cancerous or abnormal blood cells, and of restoring normal blood cell production.
The data revealed that children under the age of 18 with cancer who live in communities with high poverty rates had a 34% greater risk of treatment-related mortality following HCT compared with children in low-poverty areas. Even after adjusting for a child's disease and transplant-related factors, the data revealed children on Medicaid had a 23% greater risk of dying from any cause within five years of undergoing HCT and a 28% greater risk of treatment-related mortality when compared to children with private insurance.
"Our study shows that even after children with cancer have successfully accessed this high-resource treatment at specialized medical centers, those who are exposed to poverty are still at higher risk of dying of complications after treatment and of dying overall," said lead author Kira Bona, MD, MPH, Attending Physician, Dana-Farber/Boston Children's Cancer and Blood Disorders Center. "Simply providing the highest quality complex medical care to children who are vulnerable from a social perspective is inadequate if our goal is to cure every child with cancer."
One in five children in the U.S. lives in a household with an income below the federal poverty level. While previous studies have shown an association between household poverty and poorer outcomes in HCT procedures generally, there are limited data on how poverty influences the success of HCT in children specifically.
Dr. Bona and her team sought to fill this gap by reviewing outcomes data for pediatric allogeneic transplant recipients from the Center for International Blood and Marrow Transplant Research Database, the largest available repository of HCT outcomes. The researchers looked at two cohorts of patients: 2,053 children with malignant disease and 1,696 children with non-malignant disease, who underwent a first HCT between 2006 and 2015. Neighborhood poverty exposure was defined according to U.S. Census definitions as living within a ZIP code in which 20% or more of the residents live below 100% of the Federal Poverty Level. They also stratified patients by type of insurance and used Medicaid as a proxy measure for household level poverty. The researchers looked at pediatric patients' overall survival defined as the time from HCT until death from any cause, as well as relapse, transplant-related mortality, acute and chronic graft-versus-host disease, and infection in the first 100 days following HCT.
Interestingly, neighborhood poverty or having Medicaid insurance did not seem to affect outcomes, including overall survival, relapse, or infection, among children transplanted for non-malignant diseases such as sickle cell disease. Dr. Bona said the study does not explain why this might be and more research is needed; however, it is possible that physicians and families of children with non-malignant conditions who face social health challenges may elect to avoid intensive HCT procedures.
One study limitation is its reliance on proxy measures of household poverty (ZIP code and Medicaid insurance) that do not provide insight into specific aspects of an individual child's socioeconomic exposures and the home environment in which they live that may interfere with their ability to navigate the health care system. Dr. Bona says researchers and clinicians have historically not considered social determinants of health as being as important as biological variables in specialized cancer care and so have not collected data on these factors as part of research. She says this is a missed opportunity.
"We as a field need to recognize that non-biological variables such as your exposure to poverty and other social determinants of health matter just as much as many of the biological variables we pay close attention to when thinking about outcomes for children, and these variables must be collected systematically for research if we want to optimize the care and outcomes of the children we serve," Dr. Bona said.
If future studies could collect more nuanced measures of poverty such as household material hardship (e.g., food insecurity, access to heat and electricity, housing insecurity, transportation insecurity) or language barriers, targeted interventions in the form of assistance programs could potentially help mitigate social hardships and improve the overall care of children with cancer.
Blood(www.bloodjournal.org), the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online. Blood is a journal of the American Society of Hematology (ASH) (www.hematology.org).
SOURCE American Society of Hematology/Blood Journal
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Study: Poverty Linked to Higher Risk of Death Among Children with Cancer Undergoing Stem Cell Transplantation - PRNewswire
11-year-old urgently needs a bone marrow transplant after being diagnosed with life-threatening condition – Leicestershire Live
An 11-year-old girl is in urgent need of a bone marrow transplant after being diagnosed with a rare, life-threatening condition.
Arya Lloyd, who was born in the Leicester Royal Infirmary, started to complain of abdominal pain and aches in her back and ribs during the summer.
Her father, Geraint said "she had always been fit and healthy" and did well in sports. So it was a shock to him and his wife, Arya's mother Brundha, when she was diagnosed with aplastic anaemia in late July this year.
Aplastic anaemia, also known as bone marrow failure, is a rare disease affecting the blood whereby the bone marrow and stem cells do not produce enough blood cells.
Arya then went on to have two bone marrow biopsies after her diagnosis.
"Her blood count continued to drop and that's why it is so important to get a donor match," Geraint said.
But finding a match will be a challenge. Arya, whose mother is of Indian heritage and father is Caucasian, will wait longer to find a suitable match due to her dual heritage.
Currently, those of Asian, Black or mixed ethnic background have a 20 per cent chance of finding the best possible match from an unrelated donor, compared with the 70 per cent chance of finding a match for Caucasian patients.
Arya and her parents, who a currently live in Cambridge are "staying positive" while Arya undergoes immunosuppressive treatment at St Mary's Hospital in Paddington.
Geraint told LeicestershireLive: She has been really brave and she just gets on with it. I wish it was me rather than her going through all this but she's optimistic."
The 11-year-old schoolgirl is expected to be discharged from the hospital this week and has spent her time keeping in touch with friends and catching up with homework when she can.
It has now been 22 days since she was admitted to hospital where she has been able to stay with her mother. Due to Covid-19 restrictions, the pair have had to stay in an isolated room and unable to see Geraint who has kept in touch through video calls.
"It's been really difficult, our whole world has been turned upside-down but we need to be optimistic and find a match," Geraint said.
The family is now urging people to come forward and join the bone marrow donor register.
"It's very urgent and so important that particularly people of Indian and mixed heritage join the register as they are hugely underrepresented," Geraint said.
So far, no suitable match has been found for Arya and it will take several months to determine the effects of the treatment she is currently having.
Following the immunosuppressive treatment, Arya will be infection-prone and have to be careful to avoid any trauma or injury due to her low blood count. This also leaves her in the category of people who are at higher risk from Covid-19.
While Arya and her family continue to adjust and stay positive, they need your help.
Joining the bone marrow donor register is simple and can be done from home by ordering a swab kit that is then sent back and analysed.
You can find out more about Arya's story and how to join the register at http://www.dkms.org.uk/en/arya.
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11-year-old urgently needs a bone marrow transplant after being diagnosed with life-threatening condition - Leicestershire Live