Archive for the ‘Cell Therapy’ Category
Stem cell therapy in Hawaii going to the dogs
HAWAII KAI (HawaiiNewsNow) -
Cutting-edge technology is helping Hawaii's pets live better lives for months, even years. We were there as a beloved dog named Kumba received one of the first-ever, in-clinic stem cell therapy surgeries in the islands.
13 year old Kumba doesn't know he's a guinea pig. The Rottweiler-Lab mix is one of the first in Hawaii to undergo the stem cell procedure at Surf Paws in Hawaii Kai.
Kumba suffers severe arthritis in his hips and knees, doesn't eat much, and is even a bit depressed. "It's an effort for him to get up off the floor, and when he gets up and crosses the room, you can see the stiffness," says his owner, Rumi Hospodar.
Kumba's kids learn some of details of his surgery. Then, he's moved to a table and nods off from anesthesia. Once he's prepped, the procedure begins. The vet removes about two tablespoons of fat tissue from Kumba's shoulder. From there, the stem cells are separated from the fat and activated. Then, they're injected back into the affected areas.
The entire process takes four hours, but the dog is actually only under for about 20 minutes. Surf Paws used to send the tissue to the mainland for processing, but with technology from Medi-Vet America, they can do it all here.
"The patient had to be, you know, go home and come back a few days later and the timing was a little bit difficult. Now, everything is same day," says Surf Paws veterinarian Dr. Cristina Miliaresis.
Cost depends on the size of animal but can run up to $2,800. It's mainly done on dogs, cats, and horses who suffer osteoarthritis, hip dysplasia, ligament and cartilage damage, and other degenerative diseases. Their quality of life can improve within a couple of weeks.
Dr. Miliaresis says, "Some people might say, 'Oh, the dog's 13. Why are you doing this for a 13 year old dog? But even 6 months, pain-free, after a very, it's not simple, but it's a pretty straightforward procedure, to me (would be) just amazing."
The techs move all 97 pounds of Kumba to post-op - while his anxious owner looks on.
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Stem cell therapy in Hawaii going to the dogs
Stem Cell Therapy for CMT – Gary B-part 1 – Video
17-06-2012 02:12 Gary B. Stem Cell Therapy for CMT - For more info. visit
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Stem Cell Therapy for CMT - Gary B-part 1 - Video
Sistemic to Moderate Regenerative Medicine Panel at 2012 Bio International Convention
BOSTON--(BUSINESS WIRE)--
Sistemic Ltd., a leading provider of microRNA-based problem-solving services and kit-based products to the Cell Therapy community, announced today that chairman and CEO Jim Reid is moderating a panel discussion at the 2012 Bio International Convention on Wednesday, June 20, in Boston. Featuring leaders from the regenerative medicine space, the panel is titled Stem Cell Therapies Fact or Fiction, and will share the lessons learned to-date from Scottish, European and American perspectives on the path to successfulcommercialization of stem cell therapies.
Jim Reid, Sistemic CEO, commented, "Sistemic is very active in the CellTherapyarena and aremembersof Alliance for Advanced Therapies (AAT) and the Alliance for Regenerative Medicine (ARM). We see the ability to raise this topic at the leading world event, BIO 2012, as animportantstep on the path to commercialization of these products which will be transformational in healthcare, and bring hope and cures to many people around the globe."
More information on the panel at BIO 2012:
What: Panel Discussion Featuring Leaders in the Regenerative Medicine Space
When: Wednesday, June 20, 3:00PM EDT
Where: Boston Convention Center, Room 254A
Who: Leaders of the Regenerative Medicine space:
Panel objectives include evaluating lessons learned and best practice including from the Scotland Roadmap for the commercialization of stem cell therapies; identifying global (US and EU) examples of progress in stem cell therapy commercialization; and facilitating a debate on the need for a global, multi-disciplinary approach to successful commercialization of stem cell therapies.
About Sistemic Ltd
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Sistemic to Moderate Regenerative Medicine Panel at 2012 Bio International Convention
ViaCyte Appoints Dr. Paul Laikind Chief Executive Officer
SAN DIEGO, June 15, 2012 /PRNewswire/ --ViaCyte, Inc. today announced the appointment of seasoned entrepreneur, Paul Laikind, Ph.D., as President & Chief Executive Officer. Allan Robins, Ph.D., who was serving as Acting CEO, will continue in his role as Vice President & Chief Technology Officer. ViaCyte is a leading pre-clinical company developing a novel cell therapy product for the treatment of insulin dependent diabetes.
Dr. Laikind brings over 25 years of leadership experience in the biotechnology and life sciences industry to ViaCyte. He is a serial entrepreneur, who co-founded three San Diego companies, Gensia Pharmaceuticals Inc., Viagene Inc., and Metabasis Therapeutics Inc., serving in various executive positions including President and CEO. All three companies went public and were eventually acquired. Most recently, he served as Chief Business Officer and Senior Vice President of Business Development at the Sanford-Burnham Medical Research Institute.
"Paul brings to ViaCyte a wealth of experience in managing new businesses based on highly innovative life sciences technologies," said Fred Middleton, Chairman of ViaCyte. "We are pleased to have him join to lead ViaCyte through our next phase of development in bringing our transformative stem cell therapy to patients with diabetes. We believe Paul's leadership and business development skills will greatly assist us in our strategy to be a leader in regenerative medicine therapy and to capitalize on our current technology leadership position in the development of stem cell therapy."
As Sanford-Burnham's first Chief Business Officer, Dr. Laikind set a new direction for the Institute's business development activity through a combination of licensing and strategic partnerships with large pharmaceutical organizations, including collaborations with Pfizer's Centers for Therapeutic Innovation, Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, and Takeda Pharmaceutical. Working with the Institute's leadership team he helped establish a sophisticated infrastructure for advanced drug discovery and development at Sanford-Burnham.
Prior to Sanford-Burnham, Dr. Laikind served as President & CEO from 1999-2008 for Metabasis Therapeutics, which developed new therapies for metabolic and liver diseases. Dr. Laikind co-founded Gensia Pharmaceuticals in 1986, was a board member of the company and held various executive leadership positions. While at Gensia he was responsible for establishing a number of important strategic partnerships. In 1997, he was part of a team that restructured Gensia to focus on specialty pharmaceuticals. The restructured company was renamed Gensia Sicor and went on to be acquired for over $3 billion by Teva Pharmaceutical Industries in 2004. Soon after founding Gensia, he was co-founder of Viagene, a gene therapy company. Viagene completed an initial public offering in 1993 and was acquired in 1995 by Chiron Inc., now a subsidiary of Novartis Vaccines & Diagnostics.
Dr. Laikind earned his Ph.D. in biochemistry from the University of California, San Diego and is the inventor on a number of key patents.
"ViaCyte addresses one of the largest commercial and medical opportunities in stem-cell-derived therapeutics, and its team is internationally recognized for its scientific leadership," said Dr. Laikind. "I look forward to working with ViaCyte through clinical development and market launch of its first important product that promises to change the way we treat insulin dependent diabetes."
About ViaCyte
ViaCyte is a preclinical cell therapy company focused on diabetes. The Company's technology is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.
ViaCyte is a private company headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine.
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ViaCyte Appoints Dr. Paul Laikind Chief Executive Officer
International Stem Cell Corporation Scientists Create New Protein-Based Stem Cell Technology
CARLSBAD, Calif.--(BUSINESS WIRE)--
International Stem Cell Corporation (ISCO) http://www.internationalstemcell.com announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs." TTFs are designed to pass into stem cells and direct the stem cells to change into specific cell types that can be both therapeutically-useful and can be used as revenue-generating research products.
In contrast to more traditional cell therapy methods this technology does not require the use of viruses or chemicals, and has the potential to produce safe therapeutic cells from stem cells. In addition, the TTF proteins are naturally eliminated by the cells when no longer required, a characteristic that further improves safety. The Company intends that this technology, once perfected, will first be used to create revenue-generating research products for sale through Lifeline Cell Technologys international distribution channels to the academic, biotechnology and pharmaceutical markets for cellular proteins, including the quickly growing markets for the study of stem cell biology and drug testing.
According to Jeffrey Janus, Lifeline Cell Technologys CEO, These proteins can be sold into the market for cellular proteins which exceeds $700 million and represents an excellent opportunity for LCT to grow sales. Since the technology also has broad application in research and therapy, it should provide ISCO with future out-licensing opportunities to the biotechnology and pharmaceutical industries.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.
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Forward-looking Statements
Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
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International Stem Cell Corporation Scientists Create New Protein-Based Stem Cell Technology
Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand
COLUMBIA, Md.--(BUSINESS WIRE)--
Osiris Therapeutics, Inc. (OSIR), announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. With this decision New Zealand joins Canada, which last month became the worlds first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.
"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."
Osiris submitted a New Medicine Application (NMA) to Medsafe(New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.
"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," said Hans Klingemann, M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases.
Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.
As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made, said Sandy Barker, President and Co-founder of the Gold Rush Cure Foundation. We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number.
Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.
About GvHD
GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.
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Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand
Cell Therapeutics Appoints New Chief Medical Officer
June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.
"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."
With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.
"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.
"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."
About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.
In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.
Pixuvri is currently available in the EU through Named Patient Programs.
Pixuvri does not have marketing approval in the United States.
About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
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Cell Therapeutics Appoints New Chief Medical Officer
Abunda to try stem cell therapy for mom
MANILA, Philippines -- "The Buzz" host Boy Abunda is going to Europe this weekend with his mother, who is suffering from dementia and Alzeimers disease.
In an interview with ABS-CBN News on Tuesday afternoon, Abunda said he will bring his mother to Germany to try stem cell therapy.
"Ako ay pupunta sa Europe hindi para magbakasyon. Dadalhin ko po ang aking ina para magpagamot sa Germany. Ito po 'yung fresh stem cell therapy. Maganda 'yung dini-diretso na dahil napag-uusapan ito," Abunda said.
While Abunda is in Germany, Kris Aquino will take his place on ABS-CBN's entertainment talk show "The Buzz."
In the interview, Abunda also said he's proud of Aquino, who's now open to doing extreme adventures, while continuing to be a good mother to her two sons.
"Ang daming nagbago kay Kris. May mga bagay na hindi ko inakala na gagawin ni Kris like 'yung diving, zipline at marami pang iba. Natutuwa ako that she has become more open to many things. She has become more adventurous. She has retained being the doting mother that she is pero mas malalim ang halakhak niya ngayon sa buhay. She's just so joyful. Natutuwa ako habang pinapanood ko ang kanyang adventure sa 'KrisTV,'" Abunda said.
Abunda said he's also hoping to do a new project with Aquino.
"I'm hoping na someday ay muli kaming magtagpo sa isang palabas dahil marami ang humihiling na kami ay magsama sa isang palabas. Sigurado ako sa puso ko na kami ay gagawa at gagawa dahil magkadugtong ang aming pusod," he said.
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Abunda to try stem cell therapy for mom
TiGenix: National Reimbursement in the Netherlands Obtained for Breakthrough Cartilage Therapy ChondroCelect(R)
LEUVEN, BELGIUM--(Marketwire -06/08/12)- TiGenix (EURONEXT:TIG)
TiGenix obtains national reimbursement in the Netherlands for breakthrough cartilage therapy ChondroCelect
TiGenix (EURONEXT:TIG) announced today that its innovative cartilage repair therapy ChondroCelect has obtained national reimbursement in the Netherlands. The Dutch National Health Authority (NZa) has formally announced that ChondroCelect is to receive national reimbursement retroactively per January 1, 2012. Previously ChondroCelect was made available in the Netherlands under a risk-sharing scheme.
"We are delighted with the decision of the NZa to reimburse ChondroCelect, and look forward to working with Dutch orthopedic centers of excellence and health insurers to routinely make this breakthrough therapy available to the right patients in the Netherlands," said Eduardo Bravo, CEO of TiGenix. "Dutch clinicians and scientists have been instrumental in ChondroCelect's development and four Cartilage Expert Centers in the Netherlands have already gained extensive experience with the procedure. After having obtained national reimbursement in Belgium last year, this constitutes another major step in improving patient access to this innovative therapy. We remain optimistic that we can obtain national reimbursement in other European countries later this year."
About TiGenix
TiGenix NV (EURONEXT:TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit http://www.tigenix.com.
About ChondroCelect
ChondroCelect is the first and currently only cell therapy that has been granted market authorisation by the European Union in accordance with the Advanced Therapy Medicinal Product regulation EC1394/2007. For more information, including the European Public Assessment Report (EPAR), prescribing information, and the Summary of Product Characteristics (SPC) please visit the European Medicines Agency (EMA) website at http://www.ema.europa.eu.
Forward-looking information
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
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TiGenix: National Reimbursement in the Netherlands Obtained for Breakthrough Cartilage Therapy ChondroCelect(R)
Neil Riordan PhD – Stem Cell Therapy for Spinal Cord Injury (Part 3 of 5) || Stem Cell Treatments – Video
06-06-2012 13:09 Mesenchymal stem cell homing to tissue damage, umbilical cord stem cells historically used for anti-aging, mesenchymal stem cells role in immune system modulation, inflammation reduction and stimulating tissue regeneration, donor stem cell safety and testing, the role of HLA matching in donated umbilical cord-derived stem cells, umbilical cord blood safety data and historical use in blood transfusions, allogeneic stem cell persistence in human mothers. Treatment information at More information on Dr. Riordan at
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Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Part 3 of 5) || Stem Cell Treatments - Video
Treatment eases arthritis pain in dogs
A local veterinary clinic recently added a cuttingedge treatment.
Dr. Tina Gemeinhardt, owner of Tsawwassen Animal Hospital, is excited to be offering stem cell therapy to animals suffering from arthritis and joint issues.
"I'm excited about trying to bring some relief to dogs that are living in pain," she said.
The therapy, which uses stem cells harvested from fat that is surgically removed from the dog, is, in most cases, able to offer relief from the pain and stiffness associated with
Gemeinhardt said once it's determined the therapy is the right course of treatment for an animal, body fat is surgically removed and sent to a lab in California where the stem cells are harvested. The harvested stem cells are then sent back to the vet clinic within 48 hours and injected into the joints in question.
Gemeinhardt, who added the treatment to the clinic's list of services earlier this year, said it's not quite clear exactly how the stem cells work.
"Stem cells seem to inherently know what needs to be done in that area," she said.
The treatment is not a cure-all - the arthritis is still there but the symptoms are lessened - and it does not work instantly. The vet said most animals start to notice a difference in a month or so, and some might require follow up injections.
She said about 85 per cent of animals receiving stem cell therapy have had a beneficial response, while 15 per cent saw no response.
Beatrice, a seven-yearold chow chow, has seen remarkable results. Owner Rose McClelland said Beatrice had been having problems with arthritis in her hips for years and medication wasn't working any more.
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Treatment eases arthritis pain in dogs
The potential impact of olfactory stem cells as therapy reported in Cell Transplantation
Public release date: 5-Jun-2012 [ | E-mail | Share ]
Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair
Tampa, Fla. (June 5 , 2012) A study characterizing the multipotency and transplantation value of olfactory stem cells, as well as the ease in obtaining them, has been published in a recent issue of Cell Transplantation (20:11/12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.
"There is worldwide enthusiasm for cell transplantation therapy to repair failing organs," said study lead author Dr. Andrew Wetzig of the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia. "The olfactory mucosa of a patient's nose can provide cells that are potentially significant candidates for human tissue repair."
According to the study authors, olfactory neural stem cells can be derived from a patient's own cells, they are readily available by a minimally invasive biopsy technique, and they can be expanded in vitro. The cells are plentiful because the olfactory epithelium undergoes neurogenesis and continual replacement of sensory neurons throughout adult life.
"Using the rat as our animal model source, we examined the basic aspects of olfactory neural stem cell biology and its potential for self-renewal and phenotypic expression in various circumstances," said Dr. Wetzig. "Previously, we found that they have performed well in pre-clinical models of disease and transplantation and seem to emulate a wound healing process where the cells acquire the appropriate phenotype in an apparently orderly fashion over time."
The researchers concluded that the olfactory neurospheres contain stem cells whose capacity for differentiation is triggered by signals from the immediate environmental niche.
"Stem cell numbers were shown to be enriched by our culture methods," explained Dr. Wetzig. "We also demonstrated that when adult olfactory stem cells are transplanted into an environmental niche different from that of their origin, they demonstrate multipotency by acquiring the phenotype of the resident cells."
"This study highlights another potential source of stem cells that has shown some degree of promise in a number of studies" said Dr. John Sladek, professor of neurology and pediatrics at the University of Colorado School of Medicine. "Their relatively easy accessibility and multipotent properties are important factors that could rank these cells competitively with other stem cells thus giving them a potential impact as an excellent source for cell therapy".
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The potential impact of olfactory stem cells as therapy reported in Cell Transplantation
Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone
SAN DIEGO, CA--(Marketwire -06/04/12)- Medistem Inc. (MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).
According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.
"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.
The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.
"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.
Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.
About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.
Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.
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Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone
Stem cell therapy for cornea treatment
Hyderabad, June 2:
Picking stem cells from a patients body, sending it to a sophisticated laboratory to culture a tissue and then implanting it are pass.
A team of doctors at L.V. Prasad Eye Institute has used the tea bag or sprinkler approach to regenerate stem cells. The organisation has developed a lab-free technique that could be available off-the-shelf. This allows eye surgeons with usual facilities to perform the procedure.
The team, led by Dr Virender Singh Sangwan, used this technique to treat those who suffered chemical injuries, resulting in bleeding in the cornea.
Instead of sending stem cells to the lab for culture, the doctor picked the required number of stem cells around the cornea and sprinkled on the damaged area and then put a contact lens. In 15 days, he sees development of a good layer in the place of injured area, Prof. Balasubramanian, Head of Research at LVPEI, said.
A winner of the prestigious Shanti Swarup Bhatnagar prize, Dr Sangwan said he had conducted the procedure on about 25 patients with good results. This had been published in international scientific magazines.
He is now in the process of developing tools to help doctors.
Leber Congenital Amaurosis
Children down with the rare ocular disorders that result in gradual loss of sight can hope for a cure. Doctors are working on a gene therapy to correct this problem caused by consanguineous marriages.
Though this therapy is in vogue abroad, LVPEI says it is the first centre to carry out research on this procedure. Technically called LCA or Leber Congenital Amaurosis, doctors would refer patients to a gene analysis after studying them for indications.
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Stem cell therapy for cornea treatment
Malta opposing EU financing for stem cell research on embryos
Stem cell therapy may one day be used to cure disorders such as Fragile-X syndrome, or Cystic fibrosis and other genetic maladies.
Matthew Vella
The Maltese government wants the European Commission to abandon plans to provide funds for research activities on stem cells that involve "the destruction of human embryos".
In a declaration on the ethical principles for the Horizon 2020 programme, which is an 80 billion fund for the EU's programme for research and innovation to create new jobs, the Maltese government said it wanted more detailed guidelines on the bioethical principles that will guide research programmes.
Horizon 2020 will allow the financing of research on human stem cells - both adult and embryonic - as long as it is permitted by the national laws of member states.
The fund however will not finance human cloning, genetic modification, or the creation of human embryos intended for the purpose of research or stem cell procurement.
The European Commission does not explicitly solicit the use of human embryonic stem cells, but Horizon 2020 allows the use of human stem cells according to the objectives of the research, and only if it has the necessary approvals from the member states.
The Maltese declaration echoes previous statements by the Commission of Catholic Bishops of the EC (Comece), which said Horizon 2020 did not include greater protection of human embryos from stem cell research.
Malta says it does not want any such embryos to be used for stem cell research. The statement by the Maltese government said the Horizon 2020 programme "does not take sufficiently into account the therapeutic potential of human adult stem cells."
Malta wants Europe to commit to a reinforcement of research on human adult stem cells, and that Europe should abstain from financing matters of fundamental ethical principles, which differ among member states.
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Malta opposing EU financing for stem cell research on embryos
Dogged by pain — stem cell therapy for dogs.flv – Video
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Dogged by pain -- stem cell therapy for dogs.flv - Video
NeoStem to Present at Six Conferences in June
NEW YORK, May 31, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company focused on cell based therapies, announced today that Company management will present at six conferences in June.
International Society for Cellular Therapy Annual Meeting
National Investment Banking Association Conference
International Society for Stem Cell Research 10th Annual Meeting
The Biotechnology Industry Organization (BIO) International Conference
Alliance for Regenerative Medicine -- Clinical Outlooks for Regenerative Medicine 2012
Marcum's Inaugural MicroCap Conference
About NeoStem, Inc.
NeoStem, Inc. ("NeoStem") is a leader in the development and manufacture of cell therapies. NeoStem has a strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. That manufacturing base is one of the few cGMP facilities available for contracting in the burgeoning cell therapy industry, and it is the combination of PCT's core expertise in manufacturing and NeoStem's extensive research capabilities that positions the company as a leader in cell therapy development. Amorcyte, LLC, also a NeoStem company, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and is enrolling patients in a Phase 2 trial for the preservation of heart function after a heart attack. Amorcyte expects to begin a Phase 1 clinical trial in 2012/2013 for AMR-001 for the treatment of patients with congestive heart failure. Athelos Corporation, also a NeoStem company, is developing a T-cell therapy for a range of autoimmune conditions with its partner Becton-Dickinson. NeoStem's pre-clinical assets include its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes to be an endogenous, pluripotent, non-embryonic stem cell that has the potential to change the paradigm of cell therapy as we know it today.
For more information on NeoStem, please visit http://www.neostem.com.
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NeoStem to Present at Six Conferences in June
Stem Cell Therapy for Parkinson’s Patient.flv – Video
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Stem Cell Therapy for Parkinson's Patient.flv - Video
Makati Medical Center now offering stem cell therapy
THE MAKATI Medical Centers Cancer Center celebrated its first year anniversary and marked the occasion with the launch of its Cellular Therapeutics Laboratory. Present at the ribbon-cutting ceremony were Dr. Eric Flores, head, Spine Clinic and Stem Cell Lab; Rosalie Montenegro, Makati Medical Center president and CEO; Dr. ManuelO. Fernandez Jr., executive vice president and director, Professional Services; Dr. Remedios G. Suntay, director and treasurer, MDI Board; Dr. Benjamin N. Alimurung, medical director; Dr. Francis Chung, scientific officer, Stem Cell Lab; and Augusto P. Palisoc Jr., executive director, president and CEO, MPIC Hospital Group.
MAKATIMEDS Cellular Therapeutics Laboratory is managed by experienced scientists with extensive training and is affiliated with the International Society for Cellular Therapy.
Stem cell therapy is now being offered at Makati Medical Center (MMC) as potential cure for a wide range of illnesses, from various types of cancer and heart ailments to incurable diseases such as multiple sclerosis, Parkinsons and Alzheimers.
Stem cell therapy is believed to be effective in bone marrow transplant for leukemia patients, and with early intervention, yields desirable results among renal and prostate cancer patients.
Launched in the first year anniversary of the hospitals cancer center, MMCs Cellular Therapeutics Laboratory is equipped with technology touted to be totally unmatched in our country, says Dr. Francis Chung, scientific officer of the lab. No system exists elsewhere.
Employing the strictest sterility standards at par with that of the US Food and Drug Administration, the lab has state-of-the-art facilities. The Clinimacs CD34 Reagent System is a machine that isolates specific cells needed for the procedure, while the Flow Cytomer ensures the purity of cultured cells.
Transplantation
Sourcing the stem cells, however, is what truly sets the Philippines premier health institution apart from chi-chi spas that also push stem cell therapy for beauty and anti-aging procedures.
At MMC, healthy stem cells are acquired from the patients themselves, a process known as autologous transplantation. For those suffering from an ailment, a parent, sibling or other close relative could be the donor. The hospital strives for utmost compatibility between patient and donor through a 10-point DNA matching system.
If a battery of tests finds a patient to be up to it, medication is given to prepare him for stem cell harvest.
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Makati Medical Center now offering stem cell therapy
Di’Anno Wants Former Iron Maiden Bandmate To Undergo Stem Cell Therapy Recap
Burr, the drummer with Maiden from 1979 until 1982, has been in a wheelchair as a result of multiple sclerosis, which has been attacking his nervous system since before he was diagnosed in 2002.
MS reduces the ability of the brain and spinal cord to communicate with each other, resulting in a wide range of potentially severe symptoms. The cause is unknown and there is no cure; but in 2009 researchers made the first breakthrough in reversing symptoms through stem cell therapy.
Di'Anno tells Talking Metal Pirate Radio Burr's condition is "not very good at all." - He had a lot to say, read it here.
Classic Rock Magazine is an official news provider for antiMusic.com. Copyright Classic Rock Magazine- Excerpted here with permission.
antiMUSIC News featured on RockNews.info and Yahoo News
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Di'Anno Wants Former Iron Maiden Bandmate To Undergo Stem Cell Therapy Recap
Di’Anno Wants Former Iron Maiden Bandmate To Undergo Stem Cell Therapy
05/24/2012 . (Classic Rock) Former Iron Maiden singer Paul Di'Anno wants his ex-bandmate Clive Burr to undergo stem cell therapy, despite the costs and risks associated with the procedure.
Burr, the drummer with Maiden from 1979 until 1982, has been in a wheelchair as a result of multiple sclerosis, which has been attacking his nervous system since before he was diagnosed in 2002.
MS reduces the ability of the brain and spinal cord to communicate with each other, resulting in a wide range of potentially severe symptoms. The cause is unknown and there is no cure; but in 2009 researchers made the first breakthrough in reversing symptoms through stem cell therapy.
Di'Anno tells Talking Metal Pirate Radio Burr's condition is "not very good at all." He had a lot to say, read it here.
Classic Rock Magazine is an official news provider for antiMusic.com. Copyright Classic Rock Magazine- Excerpted here with permission.
antiMUSIC News featured on RockNews.info and Yahoo News
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Di'Anno Wants Former Iron Maiden Bandmate To Undergo Stem Cell Therapy
World’s First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal
COLUMBIA, Md.--(BUSINESS WIRE)--
Osiris Therapeutics Inc. (NASDAQ:OSIR - News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.
"I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope," said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. "As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine."
Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.
Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.
Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal's safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.
Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses, said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. "I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD."
Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.
Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research, said Peter Friedli, Chairman and Co-founder of Osiris. It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.
In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada's decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.
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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal
Family hangs hope for boy on unproven therapy in India
Indian clinic's stem cell therapy real?
STORY HIGHLIGHTS
For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.
New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.
Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.
His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.
The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.
Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.
After five weeks of treatment, Cash and his parents returned home to the U.S.
That's when Cash began walking with the aid of braces for the first time.
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Family hangs hope for boy on unproven therapy in India
TiGenix Reports Business & Financial Results for the First Quarter 2012
LEUVEN, BELGIUM--(Marketwire -05/15/12)- TiGenix NV (TIG) a leader in the field of cell therapy, today gave a business update and announced the financial results for the first quarter ending March 31, 2012.
Business highlights
Financial highlights
"In the first quarter 2012 we continued to aggressively push our commercial efforts forward," said Eduardo Bravo, CEO of TiGenix. "As a result sales of ChondroCelect are developing in line with the improved traction we observed in the second part of last year. At the same time we are moving ahead of schedule with most of our clinical adipose stem cell programs. We closed the quarter with almost EUR 17 million cash on hand, which is sufficient to execute on our business plan and reach key inflection points."
Business update
ChondroCelect sales increase continues apaceThe Company reports net sales growth for the quarter of 123% compared with the same period of last year, and of 62% compared to Q4, 2011, a positive trend reflecting the uptake in Belgium, where we benefit from national reimbursement. In the Netherlands one of the leading private healthcare insurance companies has made treatment with ChondroCelect compulsory for its insured, and no longer reimburses non-ATMP treatments. Similarly, one of the large private insurers in the UK has expressed its intention to routinely reimburse ChondroCelect going forward. Discussions to obtain full national reimbursement keep advancing in the Netherlands, France, Spain and Germany.
Positive outcome of ChondroCelect compassionate use program published in leading journalPositive outcome data from the ChondroCelect compassionate use program (CUP), involving 43 orthopedic centers in 7 European countries, treating 370 patients with ChondroCelect over the span of four years, were published in advance online in Cartilage, the official journal of the International Cartilage Repair Society. The data show that the implantation of ChondroCelect results in a positive benefit/risk ratio when used in an unselected, heterogeneous population, irrespective of the follow-up period, lesion size and type of lesion treated. In addition, the CUP study significantly expands the data set used to obtain approval for ChondroCelect from the European Medicines Agency in 2009, increasing eight-fold, from 43 to 334, the number of patients with long-term follow up data. To date almost 700 patients have been treated with ChondroCelect.
ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula on schedule The ADMIRE-CD (Adipose Derived Mesenchymal stem cells for Induction of REmission in perianal fistulizing Crohn's Disease) Phase III protocol was submitted to Ethics Committees or Health Authorities in all 8 participating countries, and to date approvals have been received in four of those countries already.
Cx611 Phase IIa in RA passes last safety hurdleOn April 17, upon review of the safety data of the first three patients of the third cohort of the company's Phase IIa clinical trial in rheumatoid arthritis (Cx611), TiGenix received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort. This fact is of major importance. In RA it ensures that the product will not be held back by any dose-limiting factors and that we will be able to move forward with the optimal treatment dose. Of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013.
Last patient treated in Cx621 Phase I clinical trialAll 10 healthy volunteers have been recruited and treated in the Phase I study of Cx621. Cx621 investigates the safety and feasibility of intra-lymphatic administration of stem cells. Intra-lymphatic administration of (all) stem cells is patented by TiGenix. The final report of this trial will be available at the end of June.
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TiGenix Reports Business & Financial Results for the First Quarter 2012
Gamida Cell Closes $10 Million E Financing Round Earmarked to Support the Global Commercialization of the Company’s …
JERUSALEM--(BUSINESS WIRE)--
Gamida Cell announced today that it has closed an internal E financing round of $10 million. All major shareholders participated.
The financing will be used to support the global commercialization of the companys lead cell therapy product, StemEx, in development as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor. The company is currently seeking a strategic partner to join in the global commercialization of StemEx.
The financing will also support the continued development of the companys pipeline of products, primarily the NiCord clinical trial for sickle cell disease and thalassemia.
Mr. Reuven Krupik, chairman of the board of Gamida Cell said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer.
The international, multi-center, pivotal registration, Phase III clinical trial of StemEx completed enrollment in February 2012. Clinical outcome is expected in Q4/2012. The market launch of StemEx is planned for 2013. StemEx is likely to be the first allogeneic stem cell product in the market. StemEx is being developed by the Gamida Cell-TEVA joint venture.
Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, With the continued support of our shareholders and the analysis of the clinical results of the StemEx trial just around the corner, we are now focused on submitting the BLA.
StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit. Competing products in development use two units. As the average cost of a cord blood unit in the U.S. is $40K, StemEx is expected to be a significantly less expensive treatment option. StemEx is also expected to be available in the market several years before any of the competing products.
About Gamida Cell
Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The companys pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, neutropenia and acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cells therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, bone marrow and peripheral blood, which are expanded in culture. Gamida Cells current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.
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Gamida Cell Closes $10 Million E Financing Round Earmarked to Support the Global Commercialization of the Company’s ...