Archive for the ‘Bone Marrow Stem Cells’ Category

A team from Northwestern University has developed a novel type of bioactive tissue that is thin and flexible enough to be folded into origami-like shapes and could be used in a variety of treatment programs.

The tissue paper was created from the structural proteins excreted by cells that give organs their form and structure, combined with a polymer to make the material pliable.

The researchers made the tissue papers from ovarian, uterine, kidney, liver, muscle and heart proteins that were obtained by processing pig and cow organs.

This new class of biomaterials has potential for tissue engineering and regenerative medicine as well as drug discovery and therapeutics, corresponding author Ramille Shah said in a statement. It's versatile and surgically friendly.

The cells are removed from the tissues, leaving the natural structural proteinsextracellular matrixthat are then dried into a powder and processed into the tissue papers.

Each paper has a type containing residual biochemical and protein architecture from its original organ that can stimulate cells to act in a certain way.

The researchers made tissue paper from a bovine ovary to grow ovarian follicleseggs and hormone producing cellscultured in vitro, which when grown on the tissue paper produced hormones necessary for proper function and maturation.

This could provide another option to restore normal hormone function to young cancer patients who often lose their hormone function as a result of chemotherapy and radiation, reproductive scientist Teresa Woodruff, a co-author on the study, said in a statement.

The ovarian paper with follicles could potentially be implanted under the arm to restore hormone production for cancer patients or women in menopause. Tissue paper made from other organs separately supported the growth of human adult stem cells when scientists placed human bone marrow stem cells on the tissue paper with all the stem cells attached and multiplied over the course of four weeks.

That's a good sign that the paper supports human stem cell growth, first author Adam Jakus, who developed the tissue papers, said in a statement. It's an indicator that once we start using tissue paper in animal models it will be biocompatible.

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'Tissue Paper' Organs Show Promise - R & D Magazine

Nalini Ambady, the first Indian-American woman to teach psychology at three major universities in the U.S., died in 2013 due to leukaemia when she was just 54.

For the medical fraternity in Kerala, her native place, it turned the spotlight on the lack of awareness of stem cell transplant, which could have saved her life.

Four years down the lane, doctors say the situation has changed only marginally, as many patients who require the treatment have not been able to do it because of high expenses, lack of matching donors, and lack of facilities at hospitals.

Doctors note that stem cell transplant is being proposed as an effective treatment for cancers such as leukaemia and lymphoma, and primary immune deficiency disorders. Stem cells do not develop normally in such patients and it affects the blood cells that they make.

By a transplant, the patient gets new stem cells that can make new and healthy blood cells. Earlier, stem cells were collected from the bone-marrow. Now, it is being collected from blood cells.

Neeraj Sidharthan, bone marrow transplant physician at Amrita Institute of Medical Sciences, Kochi, told The Hindu that in Prof. Ambadys case, though matching donors were found, they had all dropped out.

Lack of awareness is still a major issue though there are some positive signs. In some cases, because of lack of infrastructure, cancer cases are not being diagnosed early, and treatment is delayed too, he said.

Ajith Kumar V.T., professor, department of paediatrics, Government Medical College, Manjeri, said donors could not be found often from the same families because of the nuclear family system. There are not many places where you can match the human leukocyte antigen (HLA) typing with donors. Another problem is the lack of stem cell registries in the State from where matching unrelated donors could be found. Even if doctors suggest a stem cell transplant, many families dont opt for it because of the high cost involved. If the donor is from the same family, the cost is relatively low.

But for unrelated donors, it is very high, Dr. Sidharthan said. The solution, Dr. Ajith Kumar said, was government intervention to set up HLA registries and bone marrow transplant centres. nestCare Foundation, a not-for-profit organisation based in the U.S., had recently approached us expressing interest to set up these facilities in the State. Talks are on, he said. Dr. Sidharthan said that in Tamil Nadu, there was a government scheme enabling poor patients to avail themselves of a financial assistance of Rs. 7 lakh for bone-marrow transplant. We need to have similar schemes here too, he added.

A.S. Jayanth

Lack of awareness is a major issue though there are positive signs. In some cases, because of lack of infrastructure, cancer cases are not being diagnosed early, and treatment is delayed too

Neeraj Sidharthan,

Bone marrow transplant expert

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Trust those cells to help cure cancer - The Hindu

Welcome to ourOrphan Black science recaps, where Casey, a graduate student in genetics and developmental biology, and Nina, a professional science communicator, examine the science in each episode of OB and talk you through it in (mostly) easy-to-digest terms.

If you havent watched the latest episode of Orphan Black, be forewarned: there will be spoilers. There will also be crazy science.

Nina: The penultimate episode (can you believe that theres only one episode left?) of Orphan Black was all about Helena, who is about to deliver her babies.

Casey: Unfortunately, Helena has gotten herself captured by Coady and Westmorland, and their intentions are to further their personal research using Helenas babies. Of particular interest is the babies cord blood the blood from the placenta and umbilical cord that remains after birth and contains stem cells. It is becoming more and more common for people to save cord blood after they give birth due to the myriad uses these stem cells provide. Today there are almost 80 different diseases, varying from cancers to blood disorders, in which cord blood stem cells can be used as a cure.

Nina: Westmorland is ready and eager to perform a cesarean section to claim Helenas babies but Coady stops him. According to her, a cesarean section could have unpredictable epigenetic effects. The differences and benefits of c-sections versus vaginal births have long been studied for their impacts on health, and its been known that babies delivered via c-section tend to develop more immune diseases, asthma, and allergies. For one thing, babies born by c-section arent exposed to the microbes in their mothers vaginal tract, which can have impacts on how their immune functions and gut flora (digestive functions) develop.

For another: birth is a stressful experience, but that stress plays out differently depending on how the baby is born. Typically, a vaginal birth has a gradual build of stress as its pushed out, but a c-section creates a sudden shift from one environment to a new one. More than one study has remarked that these differences in stress experiences mark different patterns of methylation on their DNA. Methylation is a process that can change the activity of a DNA sequence and dictate whether a gene is expressed or not (as a rule, more methylation = repressed gene expression).Methylation is important for normal development and processes, but when it happens where it shouldnt (or doesnt happen where it should) it can cause problems.

We saw methylation mentioned once earlier this season, when Cosima was looking at Aishas medical files. She found that Aisha had low promoter methylation, which meant that a region of DNA that should have been turned off wasnt and was causing Aisha to develop tumours. One study that looked specifically at methylation of hematopoietic stem cells (the blood cell-producing stem cells found in bone marrow) in babies born vaginally versus babies born by c-section found major differences in methylation in genes linked to metabolism and immune function.

Westmorland doesnt so much care about these potential epigenetic impacts as long as they dont affect his would-be fountain of youth gene. For Coady, however, keeping these changes to a minimum is critical.

Casey: Of course, Coady doesnt want the cord blood for therapeutic uses. Getting her hands on these stem cells would provide her with a limitless source of clone genome for experimentation. While it may not be the exact genome as Project Leda, these stem cells are similar to cells obtained from Kira they contain enough of the clone genome to make them worthy of Neolutions interest.

Nina: Theres only one episode left. Lets hope Helena and her babies stay safe.

(image via BBCAmerica)

Like our science recaps? We wrote The Science of Orphan Blackthe official science companion for the show! Coming August 2017; available for pre-order now.

Casey Griffin is a graduate student in genetics and developmental biology. She obsesses over the blood-brain barrier, plays around with frog embryos, and nerds (and cries and screams) about Orphan Black. You can check out her OB Science Time Tumblr posts here.

Nina Nesseth is a professional science communicator, writer, and serial tea-drinker. Shes happiest when science-ing at people (yes, thats science as a verb). You can find her on Twitter @cestmabiologie.

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Orphan Black Science Recap: One Fettered Slave - The Mary Sue

In 2002, Ian Thompson, a specialist in facial reconstruction at Kings College, London, received an urgent phone call. A patient in his late 20s had been struck by an out-of-control car mounting the pavement. The impact had sent him catapulting over the bonnet of the car, smashing his face and shattering the fragile orbital floor the tiny bone, no more than 1mm thick, which holds the eyeball in place in the skull.

Without the orbital floor, your eye moves backwards into the skull, almost as a defensive mechanism, Thompson explains. But this results in blurred vision and lack of focus. This patient had also lost the ability to perceive colour. His job involved rewiring aircraft and as he could no longer detect a red wire from a blue one, hed barely been able to work in three years.

The accident had happened three years earlier. Since then, surgeons had desperately tried to reconstruct the bony floor and push the eye back into position, first using material implants and then bone from the patients own rib. Both attempts had failed. Each time, infection set in after a few months, causing extreme pain. And now the doctors were out of ideas.

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Thompsons answer was to build the worlds first glass implant, moulded as a plate which slotted in under the patients eye into the collapsed orbital floor. The idea of using glass a naturally brittle material to repair something so delicate may seem counterintuitive.

But this was no ordinary glass.

If you placed a piece of window glass in the human body, it would be sealed off by scar tissue, basically wobble around in the body for a while and then get pushed out, says Julian Jones, an expert in bioglass at Imperial College London. When you put bioglass in the body, it starts to dissolve and releases ions which kind of talk to the immune system and tell the cells what to do. This means the body doesnt recognise it as foreign, and so it bonds to bone and soft tissue, creating a good feel and stimulating the production of new bone.

Bioglass actually works even better than the patients own bone Ian Thompson

For Thompson, the results were immediate. Almost instantaneously, the patient regained full vision, colour and depth perception. Fifteen years on, he remains in full health.

Thompson has gone on to use bioglass plates to successfully treat more than 100 patients involved in car or motorcycle accidents. Bioglass actually works even better than the patients own bone, Thompson says. This is because weve found that it slowly leaches sodium ions as it dissolves, killing off bacteria in the local environment. So, quite by chance, you have this mild antibiotic effect which eliminates infections.

Cutting edge

Bioglass was invented by US scientist Larry Hench in 1969. Hench was inspired by a chance conversation on a bus with an army colonel who recently had returned from the Vietnam War. The colonel told Hench that while modern medical technology could save lives on the battlefield, it could not save limbs. Hench decided to shelve his research into intercontinental ballistic missiles and instead work on designing a bionic material which would not be rejected by the human body.

Hench ultimately took his research to London, and it has been in Britain where some of the most revolutionary bioglass innovations are being made in fields from orthopaedic surgery to dentistry.

Over the last 10 years, surgeons have used bioglass in a powdered form, which looks and feels like a gritty putty, to repair bone defects arising from small fractures. Since 2010, this same bioglass putty has hit the high street as the key component in Sensodynes Repair and Protect toothpaste, the biggest global use of any bioactive material. During the brushing process, the bioglass dissolves and releases calcium phosphate ions which bond to tooth mineral. Over time, they slowly stimulate regrowth.

But many scientists feel that the current applications of bioglass are barely scratching the surface of what could be possible. New clinical products are being developed which could revolutionise bone and joint surgery like never before.

Sitting in his office in Imperial Colleges Department of Materials, Jones is holding a small, cube-shaped object hes dubbed bouncy bioglass. Its similar to the current bioglass but with a slight twist: subtle alterations in the chemical composition mean its no longer brittle. Instead it bounces,like a kids power ball as Jones describes it, and its incredibly flexible.

The point of this is that it can be inserted into a badly broken leg and can support both the patients weight and allow them to walk on it without crutches, without requiring any additional metal pins or implants for support. At the same time, the bouncy bioglass also will stimulate and guide bone regrowth while slowly, naturally assimilating into the body.

To regenerate large pieces of bone, for example in a really big fracture, its very important to be able to put weight on your leg, Jones says. And its really important that the bio-implant in your leg is able to transmit the force from your weight to the bone cells, like a signal. Our body makes its own bone in the architecture that its in, because the cells feel the mechanical environment. So to grow back a big piece of bone you need to be able to transmit the right signals to them. The reason why astronauts in space lose bone mass is because without gravity, the cells arent receiving the same information as they do on Earth.

Further alterations to the chemical makeup of bioglass produce a different form which is much softer and has an almost rubbery feel. It feels almost like a piece of squid at a seafood restaurant. This bioglass is designed for possibly the holy grail of orthopaedic surgery: cartilage repair.

Right now, surgeons attempt to repair damaged cartilage in arthritic hips or damaged knee joints with a fiddly procedure called microfracture. This involves smoothing over the damaged area to expose the bone underneath, then pricking it to release stem cells from the bone marrow which stimulate repair. But this results in scar cartilage and within a few years, as many athletes have found, the original problem returns.

As a solution, Jones is looking to produce bioglass which can be 3D-printed and then slotted into any hole in the cartilage. For the cells to accept it, the material must retain all the natural properties of cartilage. To test its effectiveness, Jones uses a simulator that has human knee joints from cadavers donated for medical research.

We simulate the walking action, bending, all the things a knee would do, and make sure that the bioglass actually preserves the rest of the joint and behaves as it should do, he says. If that works then well proceed to animal and then clinical trials.

This same bioglass could find an additional use in aiding people with chronic back pain due to herniated discs. At the moment surgeons treat this by replacing the dysfunctional disc with a bone graft which fuses the vertebrae in the back together. But while this takes away the pain, it results in a considerable loss in mobility. Instead, a bioglass implant could be printed and simply inserted to replace the faulty disc.

It seems the obvious thing to do, Jones says. So far nobody has been able to replicate the mechanical properties of cartilage synthetically. But with bioglass, we think we can do it.

Weve just got to prove that we can. If all goes well and we pass all the necessary safety tests, it could reach the clinic in 10 years.

Using man-made materials which can fuse to the body may seem far-fetched but it is appearing to be a more and more likely component of future medicine. Already, millions of people brush their teeth with it. And that may just be the start.

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The best way to fix broken bones might be with glass - BBC News

BINGHAMTON (WBNG) -- Thursday, a cancer survivor met her bone marrow donor for the first time, just days before her wedding.

"They told me that without a transplant I really only had about six months to a year," said Vivian Nolan, a bone marrow transplant recipient.

In 2008, Vivian Nolan was diagnosed with a rare form of cancer called multiple myeloma. Later on, she was diagnosed with leukemia.

Doctors tried a bone marrow transplant with her own stem cells. When that didn't work, they said she needed a donor.

"The only cure or chance of holding it off at all is a bone marrow transplant," Nolan said.

Lucky for Nolan, doctors found a match.

A stranger volunteered to save her life. Scott Durbin is Nolan's donor. He lives in Kentucky, over 850 miles away.

Thursday, Durbin and Nolan met for the first time.

Nolan is getting married on Saturday.Durbin and his family flew in to support her in her next phase of life, a life that she wouldn't have without him.

"This is the man who gave me my life back. So I'm really happy," Nolan said.

For Durbin, the decision to help someone in need was second nature.

"I signed up. 7 months later I got that phone call saying they was gonna fly me to Atlanta," bone marrow donor Scott Durbinsaid.

Nolan was still in shock that someone would do something so kind for a person he had never met.

"I just couldn't believe that there was someone out there that I never knew that would go through that for me," she said.

After the transplant, Nolan wanted to meet the man who now is a part of her.

Today, she was able to introduce her family to its newest member.

"Now I've got this whole new life and he's got this whole big new family."

For Durbin, it's a choice he'd make over and over.

"I would do it again to give you a second chance," Durbin said.

Nolan remains forever grateful for that second chance.

Since her bone marrow transplant, Nolan's leukemia is virtually gone. She says she feels great, and can't wait for her new lease on life.

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Cancer survivor meets bone marrow donor days before wedding - WBNG-TV

WASHINGTON & HACKENSACK, N.J.--(BUSINESS WIRE)--MedStar Georgetown University Hospital in Washington, D.C. in collaboration with John Theurer Cancer Center, part ofHackensack Meridian Health, Hackensack University Medical Center in Hackensack, N.J., announce the 100th blood stem cell transplant performed since the BMT programs first patient was treated in September, 2013.

The patient, a woman from Arlington, Virginia, received her blood stem cell transplant at MedStar Georgetown as a treatment for multiple myeloma diagnosed in December 2016.

The BMT program at MedStar Georgetown is a joint effort with specialists from Hackensack John Theurer Cancer Center and a key component of the Lombardi Comprehensive Cancer Center, the only cancer program in the Washington, D.C. region designated by the National Cancer Institute (NCI) as a comprehensive cancer center.

Once considered experimental, BMT is todays established gold standard for treating patients with a number of malignant and other non-malignant diseases of the immune system, blood, and bone marrow, including multiple myeloma, lymphoma, and acute and chronic leukemia. For some conditions, blood stem cell transplant can provide a cure in patients who have failed conventional therapies, says Scott Rowley, MD, chief of the BMT program at MedStar Georgetown as well as a member of the John Theurer Cancer Centers Blood and Marrow Stem Cell Transplantation. For some conditions, it can actually be a cure; for others, it prolongs survival and improves quality of life. Having performed 100 BMTs at MedStar Georgetown including allogenic transplantation illustrates the strength and maturity of our program achieved in rather short time.

MedStar Georgetowns program is also the only comprehensive BMT center within Washington, D.C. and southern Maryland with accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) for adult autologous procedures, where the patient donates his or her own cells.

The BMT program at JTCC is one of the top 10 transplant programs in the United States, with more than 400 transplants performed annually.

A BMT involves a two-step process: first, collecting bone marrow stem cells from the patient and storing them for future use. Then, a week or so later, patients receive high dose chemotherapy to eliminate their disease. The previously stored cells are reinfused back into the bloodstream, where after reaching the bone marrow, they begin repopulating and allow the patient to recover their blood counts over the following 2 weeks.

Even though BMT is considered standard therapy for myeloma worldwide, in the United States fewer than 50 percent of the patients who could benefit from BMT are referred for evaluation, says David H. Vesole, MD, PhD, Co- Chief and Director of Research of John Theurer Cancer Centers Multiple Myeloma division and director of MedStar Georgetowns Multiple Myeloma Program.

Thats mostly due to physicians concerns that a patient is too old or compromised from other health conditions like diabetes, cardiac disease or renal failure. But new techniques and better supportive care have improved both patient outcomes and the entire transplant process, extending BMT to more patients than ever before.

The MedStar Georgetown/Georgetown Lombardi Blood and Marrow Stem Cell Transplant Program is part of a collaborative cancer research agenda and multi-year plan to form an NCI-recognized cancer consortium. This recognition would support the scientific excellence of the two centers and highlight their capability to integrate multi-disciplinary, collaborative research approaches to focus on all the aspects of cancer.

The research areas include expansion of clinical bone marrow transplant research; clinical study of haplo transplants use of half-matched stem cell donor cells; re-engineering the function and focus of key immune cells; and the investigation of immune checkpoint blocking antibodies that unleash a sustained immune response against cancer cells.

In this partnership, weve combined John Theurers strength in clinical care with Georgetown Lombardis strong research base that significantly contributes to clinical excellence at MedStar Georgetown. By working together, we have broadened our cancer research to offer more effective treatment options for tomorrows patients, says Andrew Pecora, MD, FACP, CPE, president of the Physician Enterprise and chief innovations officer, Hackensack Meridian Health. This is one of many clinical and research areas that have been enhanced by this affiliation.

Our teams are pursuing specific joint research projects we feel are of the utmost importance and significance in oncology particularly around immuno-oncology as well as precision medicine, says Andr Goy, MD, MS, chairman of the John Theurer Cancer Center and director of the division chief of Lymphoma; chief science officer and director of Research and Innovation, RCCA; professor of medicine, Georgetown University. Together our institutions have a tremendous opportunity to transform the delivery of cancer care for our patient populations and beyond.

ABOUT THE JOHN THEURER CANCER CENTER AT HACKENSACK UNIVERSITY MEDICAL CENTER

John Theurer Cancer Center at Hackensack University Medical Center is New Jerseys largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 14 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, the John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish the John Theurer Cancer Center from other facilities.www.jtcancercenter.org.

MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital with 609 beds located in Northwest Washington, D.C. Founded in the Jesuit principle of cura personaliscaring for the whole personMedStar Georgetown is committed to offering a variety of innovative diagnostic and treatment options within a trusting and compassionate environment.

MedStar Georgetowns centers of excellence include neurosciences, transplant, cancer and gastroenterology. Along with Magnet nurses, internationally recognized physicians, advanced research and cutting-edge technologies, MedStar Georgetowns healthcare professionals have a reputation for medical excellence and leadership.

For more information please visit: medstargeorgetown.org/bmsct

About Hackensack Meridian Health Hackensack University Medical Center

Hackensack Meridian Health Hackensack University Medical Center, a 775-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the countys first hospital, it is now part of one of the largest networks in the state comprised of 28,000 team members and more than 6,000 physicians. Hackensack University Medical Center was listed as the number one hospital in New Jersey in U.S. News & World Reports 2016-17 Best Hospital rankings - maintaining its place atop the NJ rankings since the rating system was introduced. It was also named one of the top four New York Metro Area hospitals. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades Americas 50 Best Hospitals Award for five or more years in a row. Beckers Hospital Review recognized Hackensack University Medical Center as one of the 100 Great Hospitals in America 2017. The medical center is one of the top 25 green hospitals in the country according to Practice Greenhealth, and received 25 Gold Seals of Approval by The Joint Commission more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet recognized hospital for nursing excellence; receiving its fifth consecutive designation in 2014. Hackensack University Medical Center has created an entire campus of award-winning care, including: the John Theurer Cancer Center; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Womens and Childrens Pavilion, which houses the Joseph M. Sanzari Childrens Hospital and Donna A. Sanzari Womens Hospital, which was designed with The Deirdre Imus Environmental Health Center and listed on the Green Guides list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to The Northern Trust PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Childrens Cancer Institute housed at the Joseph M. Sanzari Childrens Hospital. To learn more, visit http://www.HackensackUMC.org.

Excerpt from:
John Theurer Cancer Center and MedStar Georgetown University ... - Business Wire (press release)

Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

This press release was orginally distributed by SBWire

Albany, NY -- (SBWIRE) -- 08/04/2017 -- Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare blood disease of bone marrow stem cells, which are genetically characterized by the somatic mutation in the phosphatidylinositol glycan protein A (PIG-A) gene. PNH generally occurs in the early 30s. Around 10% patients develop PNH symptoms at 21 years of age or earlier. Around 1 to 5 individuals per million people in the U.S. are estimated to suffer from PNH. This is much lower than the incidence rate of bone marrow aplasia. PNH often goes unrecognized; delay in diagnosis may range from one year to more than 10 years.

The global PNH treatment market is anticipated to expand at a rapid pace during the forecast period. It is a niche market, with many pharmaceutical and biotech companies investing in research of bone marrow stem cells. According to current studies, the ideal treatment available is to replace all the hematopoietic stem cells with normal stem cells via stem cells transplantation. However, this treatment is not ideal in some cases as stem cell transplantation requires a stable histocompatible donor. Complete stem cells transplantation is usually considered in severe cases of PNH, for instance aplastic anemia and transformation to leukemia, as these can be life threatening complications.

Factors driving the PNH treatment market include rise in number of blood & bone marrow related disorders, increase in aging population, and technological advancements in stem cells transplantation. However, increase in cost of medical equipment, specifically surgical equipment required for stem cell transformation; lack of reimbursement policies in developing regions; and occurrence of side effects in related current available treatments may hamper the PNH treatment market.

The global PNH treatment market can be segmented based on diagnosis test, type of treatment, drugs, and end-user. In terms of diagnosis test, the market can be divided into complete blood count test (CBC), lactate dehydrogenase test (LDH), bilirubin test, bone marrow examination, urine test for hemosiderin, flow cytometry, and others. Based on the type of treatment, the PNH treatment market can be segregated into treatment of PNH patients associated with hemolysis, treatment of PNH patients associated with thrombosis, treatment of PNH patients associated with non-hemolytic anemia, allogeneic stem cell transplant (SCT)/bone marrow transplant (BMT), treatment of pregnant PNH patients, treatment of pediatric PNH patients, and others. In terms of drugs, the market can be classified into eculizumab (Soliris), ALXN1210, and others. Based on end-user, the PNH treatment market can be split into hospitals, pharmaceutical & biotech companies, clinics, academic & research institutes, and others.

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Geographically, the market for PNH treatment can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa (MEA). North America dominates the global PNH treatment market due to the rise in the number of blood & bone marrow related diseases, availability of satisfactory reimbursement policies, and increase in awareness about the early diagnosis of the disease in the region. The market in Europe is also expected to expand rapidly, as key players are collaborating with research institutions and labs to develop new innovative products. The PNH treatment market in Asia Pacific is anticipated to expand at a fast pace owing to the unmet needs regarding PNH treatment of the growing population. Additionally, factors such as development of the health care network, rise in disposable income, increase in health care awareness, and availability of reimbursement facilities are boosting the PNH treatment market in Asia Pacific.

Key players operating in the PNH treatment market include Alexion Pharmaceuticals, Inc., Thermo Fisher Scientific Inc., GE Healthcare, and Johnson & Johnson.

About Transparency Market ResearchTransparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company's exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR's experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information. Our business offerings represent the latest and the most reliable information indispensable for businesses to sustain a competitive edge.

For more information on this press release visit: http://www.sbwire.com/press-releases/paroxysmal-nocturnal/release-843409.htm

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Rise in Number of Blood & Bone Marrow Related Disorders Drives the Global Paroxysmal Nocturnal Hemoglobinuria ... - Digital Journal

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30568008.pdf - Chippewa Herald

A cancer scare helped encourage stem cell researcher Paul Knoepfler to become an outspoken watchdog over his field.

Carl Costas

By Kelly ServickAug. 3, 2017 , 9:00 AM

SACRAMENTOBack in his lab after a week of vacation, Paul Knoepfler slogs through backlogged emails: A 71-year-old woman with arthritic knees would like to know whether a stem cell clinic she researched can give her relief. The parents of a 12-year-old with a degenerative eye disease wonder whether there's any hope of averting blindness with a stem cell injection. "Kindly apprise us of expenses and chance of success," they ask.

Knoepfler, though housed in the Shriners Hospitals for Children here, isn't a physician. And his University of California (UC), Davis, lab doesn't study arthritis or eye disease, nor does he have any experience developing a stem cell therapy. He mostly uses stem cells to study cancer-causing gene mutations. But thanks to The Niche, a blog he has run since 2010, Knoepfler has become an unlikely authorityand a dogged voice of cautionon the clinical use of stem cells.

The blog, which now averages more than 4000 daily visits, has elevated him from an obscure bench scientist to an international spokesperson on all things stem cell. "It's one of the major sources of information [for the] layperson, and also for stem cell researchers," says Jeanne Loring of Scripps Research Institute in San Diego, California, an occasional commenter and guest writer on the blog.

It also has turned Knoepfler, a softspoken, unimposing presence in person, into a divisive figure. He has sounded the alarm on hundreds of U.S. physicians and clinics advertising stem cells to treat everything from sore knees to spinal cord injury. These offerings haven't been through the approval process at the U.S. Food and Drug Administration (FDA), and most aren't supported by evidence from randomized clinical trials.

"They were just saying, Screw the rules, we're just going to set up shop and put up a website and start injecting people with stem cells,'" says Knoepfler, who co-wrote a paper last year documenting the scope of this industry. "I saw that as a threat, first to patients, but to the field as well."

Stem cell researchers largely applaud his efforts. "He's been a reliable voice of reason in the field," says George Daley, a stem cell researcher at Boston Children's Hospital and dean of Harvard Medical School in Boston. Academics are "often more comfortable being provincial and insular, and not mixing it up in the public debates."

But even people who have expressed concern about predatory and fraudulent clinics contend Knoepfler has sometimes painted potential stem cell therapies with too broad a brush. "There are clinicians in the United States that are practicing forms of regenerative medicine that are legal and that are having good results for their patients," says Bernard Siegel, executive director of the nonprofit Regenerative Medicine Foundation in Wellington, Florida. "We can't tar everyone."

Siegel says he admires Knoepfler, and his foundation honored the blogger with its national advocacy award in 2013. But in Siegel's view, Knoepfler has at times acted as "almost a bit of a societal scold."

On The Niche's discussion thread, patients who believe they have benefited from unapproved stem cell treatments are harsher. "You and I will never agree on this issue," wrote one commenter, Barbara Hanson, who has sought stem cell treatment overseas for chronic obstructive pulmonary disease and runs an online forum for patients, in a discussion about the value of FDA approval. "I have experienced a much better quality of life after having stem cell treatment than I could ever have expected from prescription medications and conventional treatment."

Seven years into the conversation, Knoepfler accepts criticism in stride. But with FDA looking unlikely to tighten its grip on such clinics, and strong pressure from some patients, advocates, and companies to keep stem cell treatments outside regulators' grasp, he admits the impact of his outreach is hard to measure. "A few individuals can't really necessarily rein in a whole industry."

Paul Knoepfler's blog, The Niche, steadily gained readers in its early years, but saw a spike in 2014 with his skeptical coverage of stimulus-triggered acquisition of pluripotency (STAP) stem cell claims.

(Graphic) G. Grulln/science; (Data) Paul Knoepfler

Knoepfler's fascination with stem cells grew out of science, but his willingness to speak out started with a life-changing personal event. A college English major, he didn't commit to science until he landed a postgraduation job as a research technician at UC San Diego, where his wife was starting medical school. "Being in the lab setting felt like I was at home," he says.

While working on a doctorate there and a postdoc at the Fred Hutchinson Cancer Research Center in Seattle, Washington, Knoepfler explored the proteins and genes that act up in some childhood cancers. To understand why variations in the gene MYC and its relatives lead to childhood brain tumors, Knoepfler realized he would have to detail their normal role in the growth and differentiation of neural stem cells.

Just as he set out to establish his own lab, the state of California launched a grand experiment in stem cell funding. Motivated in part by then-President George W. Bush's ban on federal funding for embryonic stem (ES) cell research, which antiabortion groups opposed, California voters approved the $3 billion California Institute for Regenerative Medicine (CIRM). In 2006, a $2 million "new faculty" grant from CIRM helped get Knoepfler's UC Davis lab off the ground.

It had been running for 3 years when, at age 42, he was diagnosed with prostate cancer and given roughly 50-50 survival odds. Knoepfler found himself a patient at the same cancer center he frequented for research meetings and seminars. "This time, I walked straight past the auditorium for the clinic. That was a freaky moment."

Surgery led to a remission that has now lasted for 7 years. But the medical scare emboldened him "to try to expand how I had impact, beyond just the pure science," he says. Weeks after the operation, Knoepfler published the first official post on The Niche, named after a defunct stem cell blog once hosted on Nature.com that he admired. (Stem cells often reside and grow in specific niches in the body, such as bone marrow, which houses blood-forming cells.)

Early on, Knoepfler was an impassioned and partisan advocate for ES cell research. Many Republicans "are in favor of executing prisoners who might be innocent, taking away women's rights, cutting aid to poor children, eliminating Social Security," he wrote after Mississippi lawmakers introduced an amendment to give embryos constitutional protections, "but when it comes to fertilized eggs or few-days-old blastocysts, they start carrying pitchforks and torches."

As the threat to ES cell research began to feel less serious under former President Barack Obama's administration, Knoepfler's attention shifted. His periodic Google searches for "stem cells" began to turn up unfamiliar treatment centers in the United States advertising poorly validated therapies. Many clinics isolated adult stem cells from a patient's own fat or bone marrow and reinjected them, promising to heal injured joints, rejuvenate aging skin, or even repair damage from neurological disorders and autoimmune disease.

Recently, Knoepfler and bioethicist Leigh Turner of the University of Minnesota in Minneapolis set out to compile U.S. stem cell clinics marketing directly to consumers online. In a paper in Cell Stem Cell, they revealed a marketplace of 351 businesses operating at 570 clinics. "That was a tremendous piece of work," says David Jensen, a retired newspaper journalist in Paso Robles, California, who runs a blog monitoring CIRM. "You could see it was a problem if you looked out your window. The question was how big it is."

Knoepfler believes that new stem cell treatments will eventually help patients, but he has long fretted about their safety. In 2012, his team published a paper pointing out similarities between tumor cells and induced pluripotent stem (iPS) cellsadult cells reprogrammed to a more primitive state in the lab. In part because iPS cells don't face religious objections, they are an appealing alternative to ES cells. But the paper concluded that iPS cells' potential for cancerous growth could stand in the way of using them therapeutically.

The adult stem cells used in most of the emerging clinics didn't undergo the same reprogramming process, but Knoepfler still worried about their potential for uncontrolled growth. "I guess I just had this deep concern that someone was going to get cancer, maybe because of my own experience with cancer, in retrospect."

Knoepfler acknowledges that few stem cell-induced cancers and other serious side effects have been reported. But he maintains that the risk is still there, noting the case of stroke patient Jim Gass, who ended up with a tumor along his spine after a series of stem cell injections at clinics outside the United States. A report this year in The New England Journal of Medicine also documented three women who were blinded after a Florida clinic injected them with stem cells to treat macular degeneration. And even patients not physically harmed might spend thousands of dollars on useless treatments that insurers often refuse to cover.

At first, Knoepfler thought FDA would crack down on the emerging industryan expectation he now calls nave. The only FDA-approved stem cell therapies involve transplants of umbilical cord blood-derived stem cells for blood cancers and certain metabolic and immune disorders. But the agency classifies other uses of stem cells as medical procedures and exempts them from its drug approval process, provided they meet certain criteria, including "minimal manipulation" of the cells and "homologous use"using the cells for the same function they naturally perform in the body. Some uncertainty remains about which products are exemptedparticularly when it comes to fat-derived stem cells. Draft guidances FDA issued in 2014 and 2015 seemed to narrow the set of exempted therapies, but those have yet to be finalized.

Meanwhile, Knoepfler pursues his own grassroots effort with unlikely passion. "He's a sweetheart," Jensen says. "Personally, I find him sort of shy and diffident sometimes," but Knoepfler "doesn't shy away from contact with the mainstream media." He has picked apart stem cell claims that seem too good to be true, requested details from clinics, and complained about uncritical press coverage of treatments.

Even after a recent redesign of The Niche, Knoepfler's corner of the internet feels homespun and unadorned. He often illustrates his posts with corny clip art, appropriated Hollywood movie posters ("A Nightmare on Stem Street"), and cartoons he draws himself. The blog yo-yos between audiences, dissecting a technical research paper one day, raising questions about a celebrity's stem cell boob job the next. Its most visited page in the past year is a Spanish translation of his layperson-friendly explainer, "What are stem cells?"

In 2014, Knoepfler found himself fielding midnight calls from Japanese reporters after he blogged his doubts about a paper from a Kobe-based research team describing stimulus-triggered acquisition of pluripotency (STAP) stem cells, allegedly created from adult cells by simple measures such as exposure to acid. He published some of the earliest skepticism of the claim, which swiftly fell apart through failed replication attempts, a misconduct investigation, and the paper's retraction. Knoepfler chronicled the downfall of STAP stem cells blow by blow.

Other moves drew more criticism. Knoepfler took to The Sacramento Bee last June to decry what he saw as a dangerous shift in CIRM's agenda. In a Fox News oped, CIRM's then-President C. Randal Mills and Senator Bill Frist (R-TN) criticized FDA's regulatory process as too rigid. The comments came as the Senate considered legislation that would let FDA conditionally approve stem cell therapies without largescale clinical trials. CIRM "should refocus its efforts on the science and medicine of stem cells," Knoepfler wrote, "instead of lobbying for high-risk weakening of federal stem cell oversight."

The affront to the head of a major funding organization that had supported Knoepfler's own lab struck some colleagues as reckless. "I advised him not to do it," says Loring, adding, "it doesn't mean I agreed with [Mills]."

Asked about Knoepfler's criticism the next week, Mills called him "fairly self-interested" in his push for more basic research and suggested that critics of FDA reform "live with a horrible disease" before defending the agency's slow and expensive process for approving new treatments.

Knoepfler's unyielding skepticism has also turned some patients against him. In a three-part series of posts this spring, he questioned the ethics of a center at Northwestern University's Feinberg School of Medicine in Chicago, Illinois, that is attempting to treat autoimmune diseases such as multiple sclerosis (MS) by eliminating patients' immune cells and then using their bone marrow stem cells to replenish them. The principal investigator, Richard Burt, has run clinical trials, but has also provided treatment outside of trials under an FDA-sanctioned protocol known as expanded access.

After hearing that some MS patients were asked to pay as much as $150,000 to participate in a trial or receive off-study treatment, Knoepfler took to his blog. Although careful not to equate Burt's operation with for-profit clinics, Knoepfler suggested that testimonials on the center's website painted too rosy a picture of the experimental therapy and that its patient handbook encouraged fundraising efforts that might force patients to share private health information.

"It was astonishing, what he wrote," says Heather Burke of Orlando, Florida, who credits treatment at Northwestern with putting her MS into permanent remission and runs a Facebook group for patients. She says Burt tells patients that the procedure is potentially fatal and never promises improvements in their symptoms. Knoepfler's suggestion that Northwestern endorses fundraising is unfair, she adds, because for most patients, the procedure is fully covered by insurance. (Burt declined a request for comment.)

Burke shares Knoepfler's concerns about stem cell clinics that peddle shoddy science. But "Northwestern is not a popsicle stand in Mexico," she says. "When you have bloggers like Paul putting things out there like this, the only thing that they're doing is halting a possible really big breakthrough for treatments for MS."

One patient threatened to file an ethics complaint with his university. Others have accused Knoepfler of being a shill for Big Pharma, intent on suppressing alternatives to traditional drugs. (Knoepfler says he receives no funding from pharmaceutical companies.)

Knoepfler's online jabs at high-profile figures, companies, and doctors have never led to a libel lawsuitthough he says there have been a few threats. He has had tenure since 2011, and higher-ups at the university have never reprimanded him for voicing his opinions online, he says. But the stream of negativity has made him question how much longer he will continue blogging, even if he has no immediate plans to stop. "It takes a certain amount of energy just to deal with that."

He also admits that "I haven't necessarily made much headway" in convincing advocates of unfettered stem cell access that careful oversight is important, too. In recent years, nearly 40 states have passed controversial "right to try" laws, meant to allow dying patients easier access to experimental treatments without FDA oversight. And in June, Texas enacted a law that allows clinics to offer stem cell interventions without the testing and approval required under federal law. Knoepfler has predicted the change will be a boon to predatory clinics.

Still, he believes his handful of weekly email exchanges with conflicted patients is a chance to make a difference. He encourages them to get advice from their doctors, then explains why he's skeptical of approaches not proven in randomized trials. Some, he knows, will decide to go through with treatments anyway. Rarely do they write back to tell him about their decision. "That's kind of a hard part for me," he says. "I don't know the end of the story."

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The rise of unproven stem cell therapies turned this obscure scientist into an industry watchdog - Science Magazine

Stem cell therapies provide an alternative to pain relievers and total joint replacement for those suffering from osteoarthritis.

Osteoarthritis plagues millions of older adults throughout the world. It is the most common type of degenerative joint disease. Commonly referred to as OA, osteoarthritis is an inevitability for many people. It occurs as the rubber-like cartilage that protects the ends of human bones gradually breaks down. It eventually leads to a situation where bones rub against one another as little, if any, cartilage remains. OA can occur in any of the body's joints. However, it is more common in the hips, knees, spine and hands.

OA sounds like a particularly gruesome condition with painful bone-on-bone contact yet hope is available. Patients currently use physical therapy, pain relievers, cortisone injections and even surgery. Scientists have recently pinpointed stem cells as a possible catalyst for OA healing.

How the Human Body Might be Able to Heal Itself

Emory Orthopaedics and Spine Center physicians made waves five years ago when they launched regenerative stem cell therapy. This is a form of treatment for OA as well as related joint maladies. It makes use of the patient's stem cells to remedy damaged tissues, minimize pain and hasten the healing process. Stem cells are taken from the patient's body with a needle. These stem cells are derived from abdominal fat and/or the hip's bone marrow. They are then placed in a centrifuge and spun in a rapid manner to generate a concentrate. This process isolates the stem cells. These cells are injected right back into the patient's compromised joint minutes later. This reapplication of stem cells catalyzes the healing process.

The use of stem cells takes about an hour and a half. The best part is it involves minimal comfort and produces few side effects for the vast majority of patients. The stem cells are taken from the patient himself in order to decrease the odds of rejection. This method of treatment has proven quite effective, helping patients enjoy a substantial improvement in joint health in as little as one month.

Stem Cells: The Darling of Regenerative Medicine

The medical community is quickly determining stem cells enhance the healing process better than other treatments. The predecessor was platelet-rich plasma for the treatment of OA and joint damage. This method debuted nearly a decade ago. Stem cell therapy launched in 2012 and has proven incredibly effective. Stem cells are highly specialized cells that can replicate themselves and potentially differentiate into different cell types for varying functions within the body.

Though there are numerous different stem cell types, those that help promote ligament, tendon and cartilage healing are referred to as mesenchymal stem cells. The human body has a substantial amount of these cells available to repair damaged tissues. Though there is minimal evidence that adding a concentration of such cells can replace joint cartilage that has been lost, they serve as important signaling cells that promote the transmission of proteins like cytokines. These are molecular harbingers that mitigate cartilage degeneration and control pain.

Advancements in stem cells might eventually make it theoptimal means of repair for cartilage cells. Such cells aredamaged due to everyday wear and tear, sports participation, obesity, andgenetics. As of now, stem cells have proven quite effective in reducing the stiffness and pain tied to OA. It is an excellent alternative to total joint replacement surgery and pain relievers.

The FDA's Take on Stem Cells

Certain medical professionals consider stem cells to be an experimental treatment. The FDA is now attempting to determine how the number of stem cell therapies should be regulated. Unfortunately, many types of insurance do not cover stem cell treatments. Stay tuned for more developments.

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Healing Osteoarthritis with Stem Cells - Anti Aging News

Also known as hematopoietic stem cell transplant, hematopoietic cell transplant, autologous transplant, or allogeneic transplant.

A blood or bone marrow transplant replaces abnormal blood-forming stem cells with healthy cells. When the healthy stem cells come from you, the procedure is called an autologous transplant. When the stem cells come from another person, called a donor, it is an allogeneic transplant. Blood or bone marrow transplants most commonly are used to treat blood cancers or other kinds of blood diseases that decrease the number of healthy blood cells in the body. These transplants also may be used to treat other disorders.

For allogeneic transplants, your doctor will try to find a donor whose blood cells are the best match for you. Your doctor will consider using cells from your close family members, from people who are not related to you and who have registered with the National Marrow Donor Program, or from publicly stored umbilical cord blood. Although it is best to find a donor who is an exact match to you, new transplant procedures are making it possible to use donors who are not an exact match.

Blood or bone marrow transplants are usually performed in a hospital. Often, you must stay in the hospital for one to two weeks before the transplant to prepare. During this time, you will have a narrow tube placed in one of your large veins. You may be given medicine to make you sleepy for this procedure. You also will receive special medicines and possibly radiation to destroy your abnormal stem cells and to weaken your immune system so that it wont reject the donor cells after the transplant.

On the day of the transplant, you will be awake and may get medicine to relax you during the procedure. The stem cells will be given to you through the narrow tube in your vein. The stem cells will travel through your blood to your bone marrow, where they will begin making new healthy blood cells.

After the transplant, your doctor will check your blood counts every day to see if new blood cells have started to grow in your bone marrow. Depending on the type of transplant, you may be able to leave, but stay near the hospital, or you may need to remain in the hospital for weeks or months. The length of time will depend on how your immune system is recovering and whether or not the transplanted cells stay in your body. Before you leave the hospital, the doctors will give you detailed instructions that you must follow to prevent infection and other complications. Your doctor will keep monitoring your recovery, possibly for up to oneyear.

Although blood or bone marrow transplant is an effective treatment for some conditions, the procedure can cause early or late complications. The required medicines and radiation can cause nausea, vomiting, diarrhea, tiredness, mouth sores, skin rashes, hair loss, or liver damage. These treatments also can weaken your immune system and increase your risk for infection. Some people may experience a serious complication called graft-versus-host disease if the donated stem cells attack the body. Other people may reject the donor stem cells after the transplant, which can be an extremely serious complication.

VisitBlood-Forming Stem Cell Transplantsfor more information about this topic.

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Blood and Bone Marrow Transplant - NHLBI, NIH

The excitement at Jerusalem-based Gamida Cell, a maker of cell and immune therapy technologies, is palpable.

The biotechnology company has started enrolling patients for a last-stage clinical trial for a drug it believes will help increase the success of bone marrow transplants in blood cancer patients, and help them better withstand the ordeal of the lifesaving procedure.

The patients are being enrolled in the US, Spain, The Netherlands and Singapore. Should the results of the trial, as hoped, be positive, that would lead to the launch of a commercially available product in 2020, Gamida Cells CEO Yael Margolin said in an interview with The Times of Israel.

We are at an exciting transition point, and moving from being a research and development firm, based in Israel, to an international commercial firm, said Margolin who has headed the company for the past 12 years in her sun-drenched office at the biotech firms headquarters in Jerusalem. We need to prepare to commercialize the product. We are now looking at various sites in Israel for a new manufacturing facility and looking to employ some 100 people. These workers will be added to the 40 already employed in Jerusalem.

Gamida Cells CEO, Dr. Yael Margolin (Courtesy)

Preliminary clinical data has already revealed that the risk of their leading product for blood cancers, NiCord, not meeting its targets in the Phase 3 trial, is low, added Margolin.

The drug has already received a breakthrough therapy designation by the US Food and Drug Administration (FDA). The designation is given to a drug that is meant to treat a serious or life-threatening condition, and where preliminary clinical evidence indicates that it may demonstrate a substantial improvement on at least one clinically significant target (endpoint) over other available therapies. The designation also entitles the company to get more and closer FDA guidance to help bring the treatment faster to patients.

The combination of the low clinical risk based on the previous trial results and the lower regulatory risk, because the drug is being developed in close collaboration with the FDA, has spurred the company into a flurry of activity that is aimed at scaling up its production facilities to get ready for the day NiCord hits the markets.

The company said last month it raised $40 million from investors including Novartis, which is already a major shareholder in the firm. The funds will support the ongoing Phase 3 stage for NiCord. The company also announced, on July 20, that it received a $3.5-million grant from the Israeli government that will support the further development of NiCord and other drugs that the company is developing, including therapies for sickle cell disease and for blood and solid cancers. Gamida has also appointed a new chief medical officer, Ronit Simantov, who will be based in the US.

The first market for our drug will be the US, Margolin said.

The Gamida Cell lab in Jerusalem where umbilical cord blood is stored in tanks, July 16, 2017. (Shoshanna Solomon/Times of Israel)

NiCord, which would be the first drug developed by Gamida to hit the market if the trial goes well is believed to increase the chances of a successful bone marrow transplantation process for patients who do not have a rapidly available, fully matched, bone marrow donor.

Today some high-risk blood cancers cannot be cured unless patients undergo a bone marrow graft. For that purpose, a perfect 100-percent match needs to be found, a process that in the US takes an average of three to four months, if the patient is lucky. Sometimes, no match is found.

There are 70,000 patients a year globally with blood cancers who need a bone marrow transplant, Margolin said. It is a rare condition. But for that transplant, you need a donor with full tissue matching. As many as 50% dont get to the transplant phase, because they havent found a matching donor in time.

Umbilical cord blood collected from newborn babies contains stem cells, which can be used to treat diseases. Today cord-blood banks around the world store the cord blood. It great advantage is that because it is so young, there is no need for a full tissue matching.

The big advantage with umbilical blood is that you dont need full tissue matching; a partial match is enough, Margolin continued. Most patients generally find at least one unit of cord blood that partially matches them.

Stem cells in a bag in Gamida Cells Jerusalem lab, July 16, 2017 (Shoshanna Solomon/Times of Israel)

The problem is that the quantity of cells in each unit is not huge, and it is the number of stem cells in the cord blood that is critical to the success of transplantation.

Our idea is to leverage the advantages of the cord blood and overcome the limitations of the cell number by applying our own platform technology, called NAM Technology, added Margolin. This technology allows us to take one unit of umbilical cord blood and expand the number of stem cells within it and enhance their performance.

Gamida Cell selects the stem cells from the unit and puts them in a culture together with a molecule called Nicotinamide (NAM) a form of Vitamin B3 and adds other ingredients. This culture, to which the firm holds intellectual property rights, increases the number of stem cells, and enhances their functionality, Margolin said.

The cells are then harvested from the culture, frozen in a small blood-bag in a final formulation that is ready for infusion, and then shipped to hospitals via couriers. Doctors thaw the product by the bedside of the patients and infuse the fluid into them.

From start to finish, our process takes three weeks, Margolin said. The average search for a bone marrow match takes three to four months.

The clinical trial underway is enrolling patients aged 16 years and older.

An earlier trial of the drug showed that patients transplanted with NiCord showed a more rapid engraftment the amount of time needed for the development of a minimal amount of white blood cells, or neutrophils, in the blood. That minimum amount indicates the patient is now less vulnerable to infections and bleeding following the transplant, and is an indication of success.

In the pilot phase clinical trials, the median time to neutrophil engraftment with NiCord was 11 days, compared to three to four weeks in patients who received standard umbilical cord blood. The results in a study conducted at Duke University also showed a lower rate of infection 22% vs 54%; and a lower duration of hospitalization compared to standard umbilical cord engraftment, Margolin said.

Now the company is enrolling patients for its larger, Phase 3 multi-national, randomized controlled registration study. And in February it said it had already transplanted its first patient, as part of the trial.

We hope to publish positive topline data from the Phase3 study in the first half of 2019 and launch the product on the market in 2020, she said.

Metal barrel with a frozen bag of umbilical cord stem cells ready for delivery from Gamida Cells Jerusalem lab, July 16, 2017. (Shoshanna Solomon/Times of Israel)

A metal barrel within which was a frozen bag of umbilical cord stem cells was waiting to be picked by a courier in the lobby of the Gamida Cell offices, ready to be thawed and injected into a patient somewhere around the world.

We have a sophisticated infrastructure that coordinates everything between the cord bank blood and our manufacturing site and the hospital where the patient is to be treated, Margolin continued. This infrastructure is 100% robust, but we plan to scale this up toward commercialization.

The $40 million in funds the company raised last month is expected to last until late 2019. After that, she added, all options are on the table: an IPO, or teaming up with a strategic partner, are both possibilities for the future.

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Cell therapy firm in flurry of activity as hope nears for bone marrow ... - The Times of Israel

Credit: University of California, San Francisco

A virus hiding quietly in the gut may trigger the onset of a severe complication known as graft-versus-host disease (GvHD) in patients who receive bone marrow transplants, according to a new study led by scientists at UC San Francisco and Saint-Louis Hospital in Paris, France.

GvHD affects up to 60 percent of patients who undergo bone marrow stem-cell transplants, and kills about half of those affected. After transplants, to prevent a recipient's immune cells from laying siege to unfamiliar donor cells and rejecting them, clinicians often use drugs to suppress the immune response. GvHD is a mirror image of organ rejection, in which immune cells in the transplant attack its new host, the patient.

Despite the pervasiveness of this disease, there isn't yet a clear way of foretelling patients' risk of developing it before they go into surgery. The new study, published online July 31, 2017, in Nature Medicine, unveils a viral biomarker that could allow clinicians to assess patients' risk of an acute form of the disease known as enteric GvHD, which affects the gastrointenstinal system.

The team used a technique known as metagenomic next-generation sequencing (mNGS) which can rapidly and concurrently sequence genetic material of all organisms present in any biological sample to catalog microbes in patients' digestive tracts, monitoring the evolving bacterial and viral population throughout the transplantation process.

Although mNGS analyses of bacterial populations, called microbiomes, have been much in the news, fewer studies have focused on "viromes," the term for viral populations.

"Viromes can play an important part in health and disease," said Charles Chiu, MD, PhD, an associate professor of laboratory medicine at UCSF and principal investigator of the study. "Our goal was to understand what impact transplantation has on the gut virome."

In the new work, the researchers scanned stool samples taken from 44 patients before they received a transplant and up to six weeks after, and sequenced all the DNA and RNA in the samples in order to assemble a roster of their microbial passengers.

Using this technique, the researchers identified a number of viruses that flared up in the guts of patients who developed the deadly condition. Of particular note were members of the picobirnavirus (PBV) family: the presence of these viruses before transplantation, even in very small populations, was a reliable sign that a patient would likely develop the disease after a transplant.

"I would've expected herpesviruses or adenoviruses to be the more likely cause of infection," said Chiu. "We wouldn't have picked up picobirnaviruses were it not for the metagenomics approach."

PBVs are a very diverse family of viruses more diverse than HIV, said Jrme Le Goff, PhD, associate professor at the University of Paris Diderot and lead author of the new study. "It's very difficult to design a single test to detect all viruses simultaneously," said Le Goff. "So for many years, labs did not have the means to look for PBV." Indeed, each of the 18 patients who tested positive for PBV was carrying a different strain, a diversity that makes it challenging to detect PBVs using a simple lab test.

The team also observed a previously unreported "bloom" of other resident viruses in patients that occurred three to five weeks after they had received transplants. Intriguingly, the onset of GvHD appeared to trigger the late awakening of these covert viruses, laying to rest a longstanding chicken-and-egg debate: which comes first, viral infection or GvHD? The researchers conclude that much of the viral flare they saw is due to reactivation of latent gut infections following transplantation.

Given the potential utility of PBV as a predictive biomarker, Chiu and his team now hope to develop a metagenomics-based test to screen patients before transplantation. "We also saw shifts in the microbiome but those in the virome were more pronounced," said Chiu. "Loss of bacteria colonizing the gut has been thought to predispose patients to GvHD; here we show that shifts in the virome may also play a role in the occurrence of this disease."

Although the new study strongly implicates PBVs in the onset of GvHD, it is too early to tell whether or how these viruses trigger the disease. The team is now enrolling more adult and pediatric patients both in Paris and at UCSF to expand their analyses and uncover the mechanism by which the virus modulates the risk of disease. A systematic understanding of the virus's role could ultimately inform whether using antiviral drugs or tweaking the body's immune response would be the best strategy to temper the disease.

"It would be great to have a tool that can be used to assess GvHD risk in these patients before they undergo a transplant," Chiu said, a step that Le Goff said could lead to new therapies. "We hope that in the next few years we will find a way to prevent virus-associated GvHD," said Le Goff.

Explore further: Researchers develop new strategy to limit side effects of stem cell transplants

More information: Jrme Legoff et al. The eukaryotic gut virome in hematopoietic stem cell transplantation: new clues in enteric graft-versus-host disease, Nature Medicine (2017). DOI: 10.1038/nm.4380

Read more:
Gut viruses tied to potentially deadly complication of bone marrow ... - Medical Xpress

Marie Grim of Langley is looking for 100 people between the ages of 17 and 35 who are willing to take a few moments to have their cheeks swabbed.

Theres no pain, no fuss, she said.

And you could save someones life, anywhere in the world.

You could match with someone in Japan.

The campaign to sign up more potential stem cell donors, people who are willing to allow DNA samples to taken using cotton swabs, was inspired by the experience of her sister-in-law.

Cloverdale resident Tania Grim, a mother of four was diagnosed with leukemia in January.

She had to wait several months before a compatible donor was found whose stem cells will be used to replace bone marrow and abnormal white blood cells eradicated by a combination of chemotherapy and radiation.

We have been on quite the journey, Marie said.

I have sat with her at appointments and heard others get news of their donor while she had not.

Now that Tania has her donor, Marie would like to improve the odds for other families.

She already has a location and tentative date to collect the swabs September 8 at Immanuel Christian Reformed Church in Langley if she can round up enough donors.

Tania, who is preparing for her stem cell procedure in September, urged prospective stem cell contributors to sign up.

I am so grateful that the word is being spread about the huge need for donors, Tania said.

It is a very simple thing to do that can save a life.

If you are the right age to be a donor, you can contact Marie at 604-530-1326 or by email at mariegrim@hotmail.com.

Interested donors can also contact Canadian Blood Services directly at https://blood.ca/en.

More than 390,000 Canadians have joined the OneMatch Stem Cell and Marrow Network registry maintained by Canadian Blood Services, volunteering to be stem cell donors for any patient in need of a transplant, anywhere in the world.

Right now, the agency says about 70 per cent of eligible donors on the registry are Caucasian, which means the odds of finding match for other ethnicities, such as Canadians with indigenous, Asian or African heritage, are not good.

The Canadian registry connects to an international network established by the World Marrow Donor Association (WMDA) that has access to over 28 million donors in over 53 countries.

Not everyone who registers will be matched to a patient and asked to donate, but each registrant provides hope for those waiting, a message posted to the agency website states.

A person could be a match within a few months of registering, a year later or even seven years later.

If a volunteer donor is found to be a match, they face a relatively minor surgical procedure and can expect to make a quick recovery.

The agency says over 80 diseases and disorders can be treated with a stem cell transplant.

There are hundreds of patients in Canada waiting for a match, but only half of them find a match.

Patients are more likely to find a matching donor from within their own ethnic group.

The odds of family members matching is extremely slight, the agency said, which is why it does not support donor drives targeting relatives.

RELATED STORY: Surrey teen rallies stem cell donors to help with desperate need for South Asians

dan.ferguson@langleytimes.com

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Drive for stem cell donors in Langley - Surrey Now-Leader

Illustration incorporating gene-expression maps and cell images from the new research. Credit: University of Michigan

Every day, 17 million HIV-infected people around the world swallow pills that keep the virus inside them at bay.

That is, as long as they swallow those pills every day for the rest of their life.

But no matter how many drugs they take, they'll always have the virus in them, lurking in their white blood cells like a fugitive from justice.

And if they ever stop, HIV will come out of hiding and bring down their immune system from the inside out, causing the disease known as AIDS and potentially spreading to others before killing them.

Now, new research into HIV's hiding places reveals new clues about exactly how it persists in the body for years. The discovery could speed the search for drugs that can flush HIV out of its long-term hideouts and cure an infection for good.

In a new paper in PLoS Pathogens, a team led by University of Michigan researcher Kathleen Collins, M.D., Ph.D. reports that HIV hides in more types of bone marrow cells than previously thought - and that when these cells divide, they can pass the virus's genetic material down to their "daughter" cells intact.

This keeps the infection going for years, without tipping off the armed guards of the immune system.

Collins and her colleagues made the discovery in bone marrow samples donated by dozens of long-term HIV patients treated at U-M's academic medical center, Michigan Medicine, and at Henry Ford Health System in Detroit.

Using funding from the National Institutes of Health, they found that HIV can hide in hematopoietic progenitor cells (HPCs), which also serve as the parents of new blood cells that replace worn-out ones on a regular basis. HIV tricks the cells into incorporating the virus's genetic material into the cells' own DNA.

"Looking for the cells that harbor functional HIV is like searching for a needle in a haystack. Our new results expand our understanding of the type of cells that can do it," says Collins, a professor of Microbiology and Immunology and of Infectious Disease at the U-M Medical School. "It's like a cancer biology problem, only the 'mutation' in the cells is the inserted viral genome."

HPCs are made by hematopoietic stem cells, the "master cells" of blood production found in the marrow. Previous research had shown that HIV can hide for years in the bone marrow.

But it was not known whether the virus persisted only in stem cells or whether the reservoir could include more differentiated progenitor cells. Demonstrating that progenitor cells form a long-lived reservoir of virus expands the number of cell types that need to be targeted.

By demonstrating that HIV genetic material can lurk in blood progenitor cells, the researchers extend other recent studies indicating that such cells can live for years, says Collins, whose lab team included lead author Nadia Sebastian, a U-M M.D./Ph.D. student.

She notes that from the point of view of the virus, finding a harbor in this kind of cell means it can hedge its bets, giving it a chance at survival and eventual reproduction if its host's defenses weaken. The virus that causes chicken pox - varicella - also does this, hiding out in nerve cells just under the skin for years until it awakens and causes the painful condition called shingles.

Knowing exactly what cells harbor HIV over the long-term is crucial to battling persistent infections. Other research has focused on the T cells that carry out key immune system functions.

"Having established this, now we're poised to ask if we can treat HIV infection by targeting hematopoietic progenitor cells," she explains. The team is evaluating potential drugs that could kill just these cells.

The research team on the new paper also includes former U-M stem cell researcher Sean Morrison, Ph.D., who now leads a research center at the University of Texas Southwestern Medical Center. Morrison's lab uses mice as a model to study stem and progenitor cells.

They find in the new paper that in order for HIV to infect a progenitor cell, that cell must have a type of receptor on its surface, called CD4, that the virus can attach to. Additionally, the researchers show that two subtypes of HIV can infect these cells: those that use the CXCR4 co-receptor to enter cells as well as those that use CCR5, which expands the types of HIVs that can potentially cause reservoirs.

Finding those progenitor cells in the marrow of the human patients who agreed to undergo a biopsy for the sake of pure research was tricky, Collins says. But thanks to them, researchers are a step closer to a day when HIV infection is no longer a life sentence for millions of people around the world.

"Moving from the state we're in, where patients will always have to be on these drugs, to a better form of therapy where they can stop, would have a huge effect," she says. "Today's medications have side effects, as well as financial costs. To get to the next step, we need to target the types of cells that form a latent infection, including these progenitor cells."

Explore further: Scientists find that persistent infections in mice exhaust progenitors of all blood cells

More information: Nadia T. Sebastian et al, CD4 is expressed on a heterogeneous subset of hematopoietic progenitors, which persistently harbor CXCR4 and CCR5-tropic HIV proviral genomes in vivo, PLOS Pathogens (2017). DOI: 10.1371/journal.ppat.1006509

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Cells that stand in the way of HIV cure: Discovery expands understanding of marrow's role - Medical Xpress

JoAnne Viviano The Columbus Dispatch @JoAnneViviano

Dennis Matko was headed for a knee replacement when he discovered a new therapy that would instead inject his own stem cells and plasma into the joint to help prevent degradation.

The 69-year-old Clintonville resident said he had been pretty active in his 50s, leading to problems with the right knee. He eventually had his meniscus removed. He had been through physical therapy, cortisone shots and gel injections, but the pain persisted.

The therapy, he said, was a no-brainer. He was sold because the procedure involved putting his own fluids into his body with no foreign objects and no drugs.

Dr. Joe Ruane, the orthopedic doctor who treated Matko, introduced the therapy at OhioHealth, but there are a number of places using the therapy around the state and country.

It's used to treat people with osteoarthritis, the type of arthritis caused by wear and tear.

Ruane said that the need for total knee replacements in the U.S. is expected to climb by 600 percent in the next 20 years, and there is concern that there might not be enough surgeons to perform the procedures.

We need an alternative, and patients are looking for alternatives, and given the choice between a knee replacement and an injection, many patients would choose an injection, he said.

The treatment involved removing Matkos bone marrow from the back of his pelvic bone, a process done in the office under general anesthesia. The marrow was then processed to form a concentrate of stem cells and other growth factors.

Matko also had blood drawn to create platelet-rich plasma, which acts as a signaling system to get the stem cells to respond.

Ruane injected both components into the knee, delivering more than 100 stimulating and growth factors to the joint.

Ruane said the process inhibits irritating chemicals that contribute to inflammation, decreases the activity of enzymes that break down cartilage, and helps the knee to make some of its own joint fluid again.

And, to a small degree, it does help regrow some of the tissue in the knee that has been destroyed by the arthritis, Ruane said.

The procedures are most effective in young patients with early arthritis, said Dr. Adolph Lombardi of Joint Implant Surgeons in New Albany, where stem-cell and platelet-rich plasma injections are offered as separate therapies. It won't help with bone-on-bone disease, he said.

While other injections might offer short-term pain relief, platelet-rich plasma has been shown to offer a full year of relief, said Lombardi, who works with the Mount Carmel Health System. The idea is that bone-marrow stem cells, when injected into a hip or knee, can differentiate into cartilage cells and help with regeneration.

"All of this is very new but it seems to be extremely promising," Lombardi said. "This is using their own bodies' healing potential to maintain cartilage and relieve pain."

Dr. Michael Baria performs the procedure at Wexner Medical Center at Ohio State University, where the bone-marrow and platelet-rich plasma injections also are offered as separate treatments. He agreed that the hope with the bone-marrow injections is that the stem cells turn into cartilage cells, improving or halting the osteoarthritis disease.

But in his experience, the treatment is helpful for patients with advanced disease.

"The most common patient we see for this is going to be in late-stage arthritis, so kind of at the end of their rope," Baria said. "Platelet-rich plasma is usually not as good for bone-on-bone arthritis. Bone marrow doesnt seem to be limited by bone on bone."

The body has trouble healing arthritis because cartilage doesnt get enough blood supply, Ruane said. Injecting the stem cells boosts the bodys own process.

While platelet-rich plasma has been shown to decrease inflammation, stem-cell use is newer and has yet to be proven effective, Baria noted.

OhioHealth andJoint Implant Surgeons are currently in the midst of controlled randomized trials, hoping to prove the effectiveness of the procedures and obtain approval from the U.S. Food and Drug Administration.

Unless that happens, the procedure will be considered experimental, and insurance doesnt cover costs. Matko paid $2,800 for the injections at OhioHealth.

Before the treatment, Matko was having trouble with mundane things like going up and down stairs and with other activities, such as taking hikes or walks with his wife or working out. A retired police officer, he now works as a business consultant and spends a lot of time on his feet, so he was looking for better mobility there as well.

Matko said the injections have helped his knee, which is getting progressively better over time. He said hes been able to increase his activity, getting back to the gym and taking hikes and walks. He has minimal pain climbing stairs and hes more comfortable in his work.

Im not saying its all better but its much better, Matko said. Its headed in the right direction.

He realizes the treatment is not a cure.

Im not looking for a miracle, he said. I just want to forestall problems as long as possible.

.

.

jviviano@dispatch.com

@JoAnneViviano

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Patients' plasma, stem cells help knee problems - The Columbus Dispatch

A stem cell-based method created by University of California, Irvine scientists can selectively target and kill cancerous tissue while preventing some of the toxic side effects of chemotherapy by treating the disease in a more localized way.

Weian Zhao, associate professor of pharmaceutical sciences, and colleagues have programmed human bone marrow stem cells to identify the unique physical properties of cancerous tissue. They added a piece of code to their engineered cells so that they can detect distinctively stiff cancerous tissue, lock into it and activate therapeutics.

In a study appearing inScience Translational Medicine, the researchers report they have effectively and safely employed this stem cell-targeting system in mice to treat metastatic breast cancer that had spread to the lung. They first transplanted the engineered stem cells to let them find and settle into the tumor site where they secreted enzymes called cytosine deaminase. The mice were then administered an inactive chemotherapy called prodrug 5-flurocytosine, which was triggered into action by the tumor site enzymes.

Zhao said his team specifically focused on metastatic cancer, which comes when the disease spreads to other parts of the body. Metastatic tumors are particularly deadly and the cause of 90 percent of cancer deaths.

This is a new paradigm for cancer therapy, Zhao said. We are going in a direction that few have explored before, and we hope to offer an alternative and potentially more effective cancer treatment.

Zhao added that this stem cell-targeting approach can provide an alternative to many forms of chemotherapy, which has a number of bad side effects. While this widely used method is powerful enough to kill rapidly growing cancer cells, it also can harm healthy ones.

Our new type of treatment only targets metastatic tissue, which enables us to avoid some of conventional chemotherapys unwanted side effects, said Zhao, who is a member of the Chao Family Comprehensive Cancer Center and the Sue & Bill Gross Stem Cell Research Center at UCI.

This published work is focused on breast cancer metastases in the lungs, he added. However, the technology will be applicable to other metastases as well, because many solid tumors have the hallmark of being stiffer than normal tissue. This is why our system is innovative and powerful, as we dont have to spend the time to identify and develop a new genetic or protein marker for every kind of cancer.

So far, the Zhao team has done preclinical animal studies to demonstrate that the treatment works and is safe, and they hope to transition to human studies in the near future. They are currently expanding to include other type of cells, including cancer tissue-sensing, engineered immune-system T cells (called CAR-T) to treat metastasizing breast and colon cancers. They also plan to transform the technology for other diseases such as fibrosis and diabetes, which result in stiffening of otherwise healthy tissue.

Along with Zhao, UCI doctoral students Linan Liu and Shirley Zhang, are co-leading authors of the study. The National Institutes of Health, the Department of Defense, the American Cancer Society and the California Institute for Regenerative Medicine provided support.

Read more from the original source:
Stem Cell Therapy Attacks Cancer by Targeting Unique Tissue ... - R & D Magazine

BrainStorm Cell Therapeutics of Petah Tikva is recruiting American patients for a Phase 3 clinical study of its NurOwn stem-cell treatment intended to halt progression of amyotrophic lateral sclerosis (ALS).

The announcement was made in a patient webinar last week.

The NurOwn platform grew out of a technique developed at Tel Aviv University for growing and enhancing stem cells harvested from patients own bone marrow. The enhanced cells, injected via lumbar puncture, secrete elevated levels of nerve-growth factors believed to protect existing motor neurons, promote motor neuron growth and reestablish nerve-muscle interaction.

A 24-week Phase 2 safety study was concluded in 2016 on 48 participants (36 treated, 12 placebo) with possible, probable and definite ALS. This study was done at the University of Massachusetts Medical School, Massachusetts General Hospital and the Mayo Clinic.

The Phase 3 double-blind, placebo-controlled study, to begin enrollment in August, will look at efficacy and safety of repeated doses. The California Institute for Regenerative Medicine has awarded Brainstorm a $16 million grant to support the pivotal trial.

This study will accept 200 randomized study participants between the ages of 18 and 60 (half getting the treatment and half a placebo) at the three previous centers as well as California Pacific Medical Center in San Francisco, UC-Irvine near Los Angeles and another site not announced.

Potential participants must live within about 100 miles of one of the centers for ease of follow-up. They will receive three doses over a 16-week treatment phase and then undergo 28 weeks of follow-up.

BrainStorm President and CEO Chaim Lebovits said he hopes to get approval by the end of the year for a hospital exemption program in Israel an accelerated regulatory pathway that would clear the way for a first batch of 50 patients to receive NurOwn at Tel Aviv Sourasky Medical Center. However, there will be no compassionate treatment using NurOwn in Israel or elsewhere.

The NurOwn platform technology also has potential applications in any neurodegenerative disease, such as multiple sclerosis and Parkinsons.

For more information, click here.

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ALS treatment to begin Phase 3 clinical trials in US - ISRAEL21c

Regenerative medicine is a revolutionary approach to treating many degenerative conditions and includes a variety of different techniques including stem cell therapy. This field joins nearly all disciplines of science and holds the realistic promise of repairing damaged tissue by harnessing the bodys ability to heal itself.

Adult stem cells are found in every part of the body and their primary role is to heal and maintain the tissue in which they reside. Stem cells are unspecialized cells capable of renewing themselves by cell division. In addition, they have the ability to differentiate into specialized cell types. Adult stem cells can be harvested from a patients own tissue, such as adipose (fat) tissue, muscle, teeth, skin or bone marrow.

One of the most plentiful sources of stem cells in the body is the fat tissue. In fact, approximately 500 times more stem cells can be obtained from fat than bone marrow. Stem cells derived from a patients own fat are referred to as adipose-derived stem cells. The mixed population of cells that can be obtained from fat is called a stromal vascular fraction (SVF). The SVF can easily be isolated from fat tissue in approximately 30-90 minutes in a clinic setting (under local anesthesia) using a mini-lipoaspirate technique. The SVF contains a mixture of cells including adipose-derived stem cells or ADSCs and growth factors and has been depleted of the adipocyte (fat cell) population.

ADSCs are multi-potential and can differentiate into a variety of different types of tissue including but not limited to bone, cartilage, muscle, ligament, tendon and fat. These cells have also been shown to express a variety of different growth factors and signaling molecules (cytokines), which recruit other stem cells to facilitate repair and healing of the affected tissue. ADSCs are very angiogenic in nature and can promote the growth of new blood vessels.

Based on research performed in our FDA registered facilities, stem cell quality and functionality can vary greatly depending on the methods utilized to obtain the cells. It is important to utilize a product that has undergone full characterization to include safety, identity, purity and potency. We have developed a method for harvesting and isolating stem cells from fat for therapeutic use. The use of a cell population that retains the ability to function in vivo will lead to more consistent patient results with long term success.

Adipose stem cells can be obtained from the patient easily, abundantly, and with minimal patient discomfort. Clinical applications for patients can be performed in an office setting safely, legally, and ethically using autologous ADSCs. Current applications include orthopedic conditions (tendon/ligament injuries, osteoarthritis, etc.), degenerative conditions (COPD, diabetes), neurological (MS, Parkinsons, spinal cord injuries, TBI, etc.) and auto-immune (RA, Crohns, colitis, lupus).

Stem cells possess enormous regenerative potential. The potential applications are virtually limitless. Patients can receive cutting edge treatments that are safe, compliant, and effective. Our team has successfully treated over 7000 patients with very few safety concerns reported. One day, stem cell treatments will be the gold standard of care for the treatment of most degenerative diseases. We are extremely encouraged by the positive patient results we are seeing from our physician-based treatments. Our hope is that stem cell therapy will provide relief and an improved quality of life for many patients. The future of medicine is here!

For additional information on our South Miami clinic, visit http://www.stemcellcoe.com.

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Regenerative Medicine: The Future of Medicine is Here Miami's ... - Miami's Community Newspapers

When the Japanese researcher Shinya Yamanaka managed to reprogram adult cells into an embryonic-like state to yield induced pluripotent stem cells (iPSCs), this was supposed to herald a revolution in regenerative medicine. But 10 years after their discovery, a therapeutic breakthrough is still outstanding.

The overall stem cell therapy field has failed today to show a very clear cut clinical benefit, told me Georges Rawadi, VP for Business Development at Celyad. The field now needs some significant success to attract attention.

Even though investors prefer placing their bets on the hot T cell therapies these days, some stem cell technologies such as iPSCs are starting to get traction as big industry players are exploring the territory. Last year, Bayer and Versant threw $225M into the pot to launch BlueRock Therapeutics, a regenerative medicine company that plans to develop iPSC-based therapies. A year before, Fujifilm spent $307M to acquire the iPSC company Cellular Dynamics.

Although a big success story is still lagging behind, recent advances in the field argue that stem cells indeed have the potential to translate into effective therapies for currently intractable diseases. Heres an overview of what biotechs stem cells are up to!

Stem cell treatment is not a new concept hematopoietic stem cells (HSCs) were described as early as the 1960s and bone marrow transplants have been used to treat blood cancer for decades.

The reason that we get excited about stem cell therapies comes from our experience with the hematopoietic stem cells. If you want to see what a mature stem cell therapy is like, you only need to look at bone marrow transplantation explained James Peyer, Managing Partner at Apollo Ventures, who has a Ph.D. in stem cell biology.

According to Peyer, the hematopoietic stem cell field is one of the most active areas in the stem cell world right now, mainly fueled by our advances in the gene editing space. Tools like CRISPR and TALEN allow for the genetic modification of a patients own bone marrow stem cells, which can then be expanded and returned to the patient for the correction of a genetic defect.

Last year, regulators gave green light to one of the first therapies of this kind. Strimvelis, developed by GSK, consists of an ex vivo stem cell gene therapy to treat patients with the very rare type of Severe Combined Immunodeficiency (SCID). Using the patients own cells avoids the risk of graft versus host disease (GvHD), which still affects around 30% of people receiving a bone marrow transplant.

Small wonder that the CRISPR companies, CRISPR Therapeutics, Editas, and Intellia are all active in this field, with preclinical programs in a number hematological diseases.

To date, the most prominent stem cells in the clinic are mesenchymal stem cells (MSCs), which are moving through more than 300 registered clinical trials for a wide array of diseases. These cells are able to form a variety of tissues including bone, cartilage, muscle or fat, and can be readily harvested from patients or donors for use in autologous or allogeneic therapies.

While MSCs have deluded the biotech scene with good safety profiles in clinical trials, their actual regenerative potential remains controversial, and there have been a great number of clinical failures, which many blame on a lack of demonstrated mechanisms of action.

As Peyer explained, The problem here is that, as opposed to other adult stem cells, the MSC has been unclearly defined. We know roughly what it does but we dont fully understand the molecular mechanisms driving these cells. On top of being unclearly defined, the regenerative powers of MSCs have been massively over-claimed in the past.

Another reason for the lack of clinical benefit has also been attributed to the use of undifferentiated MSCs, as Rawadi explained to me. The Belgian biotech Celyad, which has been pioneering cell therapy in the cardiovascular space, is using bone-marrow derived autologous MSCs and differentiates them into cardiomyocyte precursors to produce new heart muscle in patients with heart failure.

Although the company missed its primary endpoint in a phase III trial last year, Celyad has staked out a patient subpopulation that showed significant improvement. Its technology still has the confidence of the FDA, which just handed out a Fast Track designation and Celyad is now planning a refined Phase III trial.

One of Celyads major competitors, Australian Mesoblast, is forging ahead using allogeneic MSCs with Phase III programs in heart failure, chronic low back pain (CLBP) due to disc degeneration, as well as a range of inflammatory conditions including GvHD and rheumatoid arthritis.

Although the ability of MSCs to regenerate tissues remains questionable, the Mesoblasts approach hinges on a body of evidence showing that MSCs can suppress inflammation and mobilize endogenous repair mechanisms through indirect effects on immune cells.

Indeed, the first-ever approved stem cell therapy, Prochymal, also depends on this mechanism. Prochymal was developed by US-based Osiris Therapeutics and in 2012 received Canadian approval to treat acute GvHD. But after Sanofi opted to shelve its partnership with Osiris prior to FDA approval, the biotech sold out its off-the-shelf stem cell platform to Mesoblast in a $100M deal.

In Belgium, companies like TiGenix and Promethera are also banking on the immunomodulatory properties of MSCs. The companies are developing treatments for patients with Crohns disease and liver diseases, respectively.

The ultimate hope for stem cell therapies has been to regenerate damaged or diseased tissues as found in diabetes, heart failure or blindness. Holostem Terapie Avanzate, a spin-off from the University of Modena and Reggio Emilia was the first company to move towards this goal.

Building on 20 long years of research, the biotech has developed Holoclar, the first and only autologous stem cell therapy (apart from bone marrow transplants) to enter the European market. Holoclar is based on limbal stem cells, located in a part of the eye called the limbus, which can be used to restore eyesight in patients that have lost sight due to burn injuries.

Meanwhile, UK-based Reneuron is developing off-the-shelf therapies that aim to restore the cognitive function of patients following a stroke. Backed by no other than Neil Woodford, the company recently raised an impressive 100M to advance its lead therapy to the market.

The biotechs fetal-derived neural stem cell line CTX was able to significantly reduce the disability of post-stroke patients in a Phase II trial and ReNeuron is now planning to push its candidate into pivotal trials.

A major question in the space a decade ago was safety. Today, theres been a lot of trials done that show that safety is not an issue. I think safety is kind of off the table but efficacy is still a question mark. And thats what were trying to deliver now, Olav Helleb, CEO of ReNeuron, told me.

While neural stem cells and other tissue-specific stem cells are able to regenerate the cells of a particular tissue, Embryonic Stem Cells (ESCs) and their engineered counterparts, iPSCs, are capable of making every cell type in the body, a property known as pluripotency. Pluripotent stem cells can also expand indefinitely in culture and their identification unlocked massive expectations for these cells to transform the regenerative medicine field.

Yet, these cells come with significant challenges associated with the safety of the final preparation. Apart from ethical issues surrounding ESCs, today, a lot of companies have been cautious about using these cells for therapy, because undifferentiated pluripotent cells can drive tumor formation, explained Rawadi. Since ESCs can, in principle, form every cell type, they can lead to the formation of teratomas.

A major reason for the fairly slow progress in the field is based on the difficulties of directing a pluripotent cell to exactly the cell type that is needed for cell therapy. We can readily drive the cells from the undifferentiated state to the differentiated state. However, getting those cells to pause anywhere in the middle of this continuum to yield progenitor cells is incredibly challenging, Peyer explained. Another challenge, he says, is to engraft the cells in the right place to enable them to become fully integrated.

Besides initial hurdles, companies like US-based Asterias or ViaCyte are now running the first Phase I/II trials with ESC-derived cells to treat patients with spinal cord injuries and to restore the beta cells in type I diabetes. So far, the eye has been the the dominant organ for many of the first human clinical trials with pluripotent stem cells, where the cells are assessed in diseases such as age-related macular degeneration (AMD) to restore the loss of the retinal epithelium.

Deriving retinal epithelium from pluripotent cells is relatively easy and in fact, researchers in Japan are now running the very first clinical trial using donor-derived iPSCs to treat patients with AMD. For reasons of safety and standardization, the trial is based on an allogeneic approach. However, since this doesnt offer an exact genetic match, allogeneic therapies raise the prospect of immune rejection, an issue that has been plaguing the use of ESCs.

But the scientists in Japan have contended that iPSC banks could potentially solve this problem. The team in Japan is currently establishing an iPSC bank, consisting of HLA-characterized cell lines from 5-10 different donors, which should match 3050% of Japans population.

Such haplobanks have the benefits of allogeneic cell therapy, namely cost-effectiveness and standardization, but you still have matching immune systems, Peyer agrees.

For now, this remains a vision for the future, but the potential seems enormous. As Julian Howell, CMO of ReNeuron, told me, iPSCs have still got an awful long way to go. For the iPSC program running in Japan, they recently acknowledged that it took about $1.5M and 6 months to treat each patient. Its a great idea but its still got some way to go before it reaches the scale that could get into the clinic.

Images via nobeastsofierce,Natali_ Mis,vchal/ Shutterstock

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Regenerating the Body With Stem Cells Hype or Hope? - Labiotech.eu (blog)

Cell harvesting is a technique of collecting stem cells for regenerate, transplant or repair the damaged organ with healthy functioning ones. Cell harvesting is considered as an important step in biopharmaceutical manufacturing industry that can directly affect the product quality and related downstream processes. Stem cells harvesting helps in treating with diseases namely cancers, blood disorders, immune deficiency diseases and various injuries. This therapy is also beneficial for burn victims which help them in grafting new skin cells as a replacement for damaged ones. Many companies are focusing on regeneration of myocardial tissue by injection of cell graft consist of adult stem cells from the patients for manufacturing regenerating medicines. For the treatment of eye diseases new healthy cells are also be grown. For harvesting bone marrow a companies are manufacturing devices with passive flexible drilling unit and suction mechanism which will help in reducing the invasiveness of bone marrow transplantation. Cell harvesting system helps in reducing the invasiveness of bone marrow aspiration from the iliac bone with less punctures. Moreover, helps in reducing procedure time and contamination by T-cells.

Cell Harvesting Systems Market are witnessing maximum growth owing to increase bone marrow transplantation procedures attributed to high prevalence of blood cancer and anemia. Moreover, improving healthcare expenditure, survival rate after treatment, increasing investment in logistic services, expansion bone marrow transplant registry for heart along with neuronal disorders and growing per capita healthcare expenditure. However, high cost of cumbersome treatment, lack of reimbursement policies, immunological rejection, viable cell density, and identification of stem cells in adult tissues, and complications during cell harvesting and inadequate number of HSCs cells for transplantation is a major barrier to the cell harvesting systems market.

The cell harvesting systems market has been classified on the basis of techniques, application and end user.Based on techniques, the cell harvesting systems market is segmented into the following: Altered Nuclear Transfer, Blastomere Extraction; Based on application, the cell harvesting systems market is segmented into the following: Bone Marrow, Peripheral Blood, Umbilical Cord Blood, Adipose Tissue; Based on end-user, the cell harvesting systems market is segmented into the following: Research Centers, Academics Institutes, Diagnostic Labs, Hospitals

Cell harvesting systems market witnessed substantial growth owing to equipment efficacy and accuracy during stem cells harvest. By application type, bone marrow aspiration is anticipated to hold the major share in the cell harvesting systems market owing to less process error, safe and simple procedure and less side effects. People suffering from Leukemia eligible for bone marrow transplant, is expected to contribute highest share in the global cell harvesting systems market. Cell harvesting systems helps in enhancing proper pigmentation in scar reconstruction which encourage companies for continuous technology advancement in both cell isolation techniques and downstream purification processes.

Depending on geographic region, cell harvesting systems marketis segmented into seven key regions: North America, Latin America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa. Asia Pacific dominates the cell harvesting systems marketfollowed by Europe, Japan and North America owing to high concentration of bone marrow stem cells harvesting centers and registries along with skilled doctors for the process of harvesting stem cells in these regions. Asia Pacific, Middle East and Africa hold huge potential and shows substantial growth in terms of wide acceptance of new technologyowing to awareness among population, increasing healthcare expenditure along with high number of potential candidate for the procedure.

Key players of cell harvesting systems market are PerkinElmer Inc.Tomtec, Bertin Technologies, TERUMO BCT, INC., hynoDent AG, Avita Medical, Argos Technologies, Inc., SP Scienceware, Teleflex Incorporated., Arthrex, Inc., Thomas Scientific, BRAND GMBH

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Growth Opportunities in Cell Harvesting Systems Market: New Research Report - LANews By Abhishek Budholiya (press release) (blog)

SINGAPORE The use of stem cell treatment to repair liver cirrhosis, or hardening of the liver, will be tested in a clinical trial here involving 46 patients and costing S$2.6 million.

The four-year study, which was launched yesterday, came amid a growing waiting list in Singapore for a liver transplant, which is currently the only cure for patients with end-stage liver cirrhosis.

Conducted by a multi-centre team from several restructured hospitals here, the study is led by the National University Hospital (NUH).

Liver failure is one of the top 20 causes of death in Singapore, but many patients are not suitable for a transplant due to factors such as age and surgical fitness.

Out of every five patients doctors see with end-stage liver disease, only one qualifies for a liver transplant, said Dr Dan Yock Young, principal investigator of the clinical trial and senior consultant at NUHs division of gastroenterology and hepatology.

(A liver transplant) is curative, but it is a complex procedure, and many patients are not suitable for it. For these patients, treatment is limited, but morbidity and mortality rates are high as high as 50 per cent in one year and this is probably worse than many (of the) other terminal illnesses we talk about today, he said.

Animal studies conducted over the last five years have shown that stem cells can reconstruct the micro-environment of a normal liver.

Like how branches are of critical importance in supporting the leaves and fruits of a tree, the endothelial (stem) cells contribute to supporting a nutritious environment for the hepatocyte (liver) cells, Dr Dan explained.

While similar stem-cell studies have been conducted in other centres in Asia, there has been no definitive evidence of the benefits of the treatment for liver patients.

The study will recruit 46 patients aged between 40 and 70 years old, and who are at the terminal stages of chronic liver disease, over three years. It is funded by the National Medical Research Council.

During the clinical trial, patients will be divided into a therapeutic group and a control group.

All patients will receive an injection to stimulate their bone marrow cells as part of the supportive treatment for their liver cirrhosis. However, only patients in the study group will have the stem cells from the bone marrow extracted and deposited directly into their liver for more targeted repair.

Using ones own stem cells will avoid the problem of cell rejection.

The liver tissue will be examined three months later, and an investigation to compare pre- and post-transplant results will be conducted after a year.

Since invasive surgery is not required for stem-cell therapy, the fatality risk is significantly lowered for the patient. However, other risks such as severe bleeding and infections still remain, given the patients weakened condition.

NUH also noted that the stem-cell therapy does not replace liver transplants, and the latter remains the best available treatment for liver cirrhosis.

It is very painful to turn patients away when we cannot offer them a liver transplant, said Dr Dan, adding that this stem cell therapy will serve as an alternative option.

We hope that this is a stepping stone to trials for stem cell candidates, he added.

MORE WAITING FOR A LIVER

The number of people on the waiting list for a liver transplant has been growing in recent years. In June last year, it was reported that there were 54 people on the list, more than double the 24 patients in 2011.

Chronic Hepatitis B remains the primary cause of non-alcoholic fatty liver disease, which refers to a range of liver conditions affecting people who drink little to no alcohol. However, obesity has become a contributing factor to the illness as well.

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New NUH study to test stem cells as treatment for liver disease - TODAYonline

Professional medical organisations have raised concerns about these expensive cell therapies

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

So whats on offer?

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on the rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

Rather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

Whats approved?

At present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

The action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

For more information on recognised stem cell treatments visit the National Stem Cell Foundation of Australia and Stem Cells Australia, Choice Australia, EuroStemCell, International Society for Stem Cell Research, and International Society for Cellular Therapy.

Megan Munsie, Deputy Director - Centre for Stem Cell Systems and Head of Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, University of Melbourne and John Rasko, Clinical Haematologist and President-Elect, International Society for Cellular Therapy., University of Sydney

This article was originally published on The Conversation. Read the original article.

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Private clinics' unproven stem cell treatment is unsafe and unethical - Business Standard

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WVU researchers study leukemia, bone marrow treatments - The Dominion Post

Firefighter Dustin Luebke puts his life on the line everyday protecting and serving the community. Never did he think his life would be threatened in a different way.

So now in 2017, Im going through it for the third time. So now its again recurring Hodgkins, said Luebke.

It all started in March of 2014. After 12 rounds of chemotherapy and six months in remission, it came back. He needed a stem cell transplant and was able to use his own stem cells.

Shortly after completing a year of chemotherapy after the transplant, it came back for the third time.

Its tough to swallow the first time and the second time. And then with the third time, its frustrating, said Luebke.

This father to three little girls will eventually need a bone marrow transplant.

But with this time, right now Im just doing an immunotherapy and were hoping that brings it back down to a cellular level and I can be on that for as long as until it stops working. So then it would require a stem cell transplant with a donor this time, said Luebke.

Thats where you and I can do our part and become part of the bone marrow registry and potentially be the match and save a life like Luebke's.

You fill out a short questionnaire. It talks about your health history and some personal questions, like how willing would you be to become a donor and then the swabbing process is really simple. We just swab each of your cheeks for a couple of minutes and then youre done, said Jalisa Spittler, transplant coordinator.

Spittler says 70% of patients who need a donor dont have a match in their family making the bone marrow registry their only hope.

We do have a lot of patients here that are waiting for matches that we just cant find for them. So its really helpful if we can create a diverse list with tons of people from here in South Dakota, said Spittler.

I got three little girls to raise and beautiful wife at home so I gotta stick around for a few more years, said Luebke.

Its pretty tough to realize that now youre relying on someone else where before it was all the medicine and just chemotherapy and now youre relying on somebody else with healthy stem cells to keep you going, said Luebke.

Sometimes it takes months to find a match.

Its taxing on them because they have to take more chemotherapy the longer it takes us to find a match for them. And the more chemotherapy they take, the harder it is on their body to get through the transplant. So its really important that we have a huge number of people to look at first, said Spittler.

Theres many ways that you can help out with people lives. And whether its in a fire, on a medical call and even helping somebody with life itself and furthering their life and making it better so they dont have to do chemotherapy anymore, said Luebke.

Luebke is a hero to this family and the community.

The first step to being someones cure is to join Be the Match Registry.

This Tuesday at the Oyate Community Center in Sioux Falls, there will be a bone marrow registry drive from noon to 7PM. It is put on by Avera, the city of Sioux Falls, and Be the Match. Registering takes less than 15 minutes.

For more information, just call 877-AT-AVERA.

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Avera Medical Minute AMcK: Firefighter with recurrent Hodgkin Lymphoma will need bone marrow transplant in future ... - KSFY