Category Archives: FDA Stem Cell Trials

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (OSIR), announced today that it has reached agreement with the United States Food and Drug Administration (FDA) regarding the regulatory pathway for its Biosurgery products, Grafix and Ovation. After discussions with the FDA, the regulatory status of Grafix is confirmed and the product will remain on the market as a wound cover for the treatment of acute and chronic wounds. For certain expanded indications for Grafix, Osiris has committed to submit a Biologics License Application (BLA). Osiris will leverage existing clinical data in the preparation of the applications, including data from Protocol 302, its multi-center, randomized controlled trial which demonstrated a 192% relative improvement in closure rate of chronic diabetic foot ulcers as compared to patients receiving conventional therapy (p Additionally, Osiris will continue transitioning its Ovation product line over to the companys newly launched OvationOS formulation and has agreed to complete this transition no later than the second half of 2014. We are pleased with the regulatory clarity this agreement provides and are excited to take this leadership role as we work with FDA in the evolving science and regulation of regenerative medicine, said C. Randal Mills, Ph.D., President and Chief Executive Officer … Continue reading →

Mitochondria (green) in egg cells carry an independent lineage of DNA that can pass on genetic defects. P. MOTTA/DEPT. ANATOMY UNIV. ROME LA SAPIENZA/SPL Regulators in the United States are considering whether to permit trials of a controversial assisted-reproduction technique intended to help women to avoid passing certain genetic defects on to their children. On 22 October, the US Food and Drug Administration (FDA) is scheduled to meet in Silver Spring, Maryland, to discuss a method that could prevent transmission of defects in mitochondria cellular components that contain a small amount of DNA from mother to child. The defects, which can cause fatal developmental conditions, affect as many as 4,000 US births a year. The technique places nuclear DNA from the egg of a woman with a mitochondrial defect into a donated egg that has had its nuclear DNA removed, but contains healthy mitochondrial DNA. Once the egg is fertilized, the resulting embryo would, in a sense, have three parents, because the donor mitochondrial DNA is passed down along with the mother and fathers nuclear DNA. The FDA was asked to look into the issue by developmental biologist ShoukhratMitalipov at Oregon Health and Science University in Beaverton, who last year … Continue reading →

NEWARK, Calif., Oct. 2, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug (IND) application for clinical testing of the Company's proprietary HuCNS-SC(R) human neural stem cells as a treatment for spinal cord injury. As a first action under this IND, the Company is working to open U.S. sites for its Phase I/II clinical trial for chronic spinal cord injury, which is currently underway in Switzerland and Canada. "This IND is a significant step forward for our spinal cord injury program," said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc. "With regulatory authorization from Switzerland, Canada and now the United States, we have the first international trial of a stem cell therapy for spinal cord injury. To date, we have transplanted seven patients from Germany, Norway, Italy, Israel, Canada, and the United States at Balgrist University Hospital in Zurich. We now look forward to enrolling patients at U.S. and Canadian sites and easing the travel burden for North American-based patients. Our goal is to complete enrollment in the trial by the first quarter of next year. This is the Company's … Continue reading →

SAN DIEGO, CA--(Marketwired - Sep 26, 2013) - Bio-Matrix Scientific Group Inc. (OTCQB: BMSN) announced today its subsidiary Regen BioPharma Inc. signed an agreement with Dr. Wei-Ping Min covering experiments requested by the FDA in support of clearance for the company's IND #15376 for use of HemaXellerate I in the treatment of drug refractory aplastic anemia. Regen BioPharma filed an Investigational New Drug (IND) application for HemaXellerate I in February 2013 seeking permission from the FDA to initiate a ten patient clinical trial. The FDA reviewed the Company's IND application and had a series of questions, which the company responded to on June 7th. The first series of comments were related to the manufacturing of HemaXellerate I and were successfully addressed. Subsequently the FDA responded with a second series of comments relating to cellular responses in mouse models of aplastic anemia. Regen BioPharma has been in discussions with Dr. Wei-Ping Min, who also sits on the company's scientific advisory board regarding responding to the FDA comments. On September 24th, Dr. Min signed a services agreement for conducting the animal studies requested by the FDA. "Having worked in an advisory capacity with Regen BioPharma for more than a year now, I … Continue reading →

SAN DIEGO, CA--(Marketwired - Sep 25, 2013) - Bio-Matrix Scientific Group Inc. (OTCQB: BMSN) announced today that its Regen BioPharma subsidiary is currently developing research plans for its breast cancer immunotherapeutic product, dCellVax.This cell therapy is based on patent # 8,389,708 obtained from Dr. Wei-Ping Min of the University of Western Ontario as well as an international patent portfolio licensed from Benitech Biopharma Ltd. The dCellVax therapeutic product is based on extracting blood from patients, growing a specialized type of immune cell from the bloodcalled the "dendritic cell" and then subsequently genetically modifying the dendritic cell to become resistant to cancer's immune suppressive activity.It is known that cancer modifies the immune system by producing proteins which result in immune suppression.One suchprotein which cancer stimulates is an enzyme, indolamine 2,3 deoxygenase (IDO), which cancer turns on in dendritic cells.While dendritic cells are usually immune stimulators, dendritic cells found in cancer patients suppress the immune system as a result of expressing IDO. Researchers at the University of Western Ontario, led by Dr. Wei-Ping Min, have demonstrated that using a genetic blockade of IDO in dendritic cells makes them resistant to the effects of cancer, and allows them to stimulate potent immune responses … Continue reading →

Arcadia, CA (PRWEB) September 25, 2013 Retina Institute (RIC) announced that its ground-breaking study, using stem-cell based therapy for advanced geographic atrophy, won FDA approval to move into the next phase. "Our original work with 29 patients in the Phase 1b/2a showed a positive result in a large enough group of patients to warrant advancement of this study, said Michael Samuel, MD, Retina Institute surgeon and co-founder. There are only two sites in the world that are providing this treatment for advanced macular degeneration (AMD), and that is here at RIC and in Philadelphia. The study will allow patients with 20/80 or worse vision with central geographic atrophy related to AMD. The cells in use are non-embryonic in nature, are registered with the National Institute of Health Clinical Trials registry, and will be zero out-of-pocket cost for patients. There will also be modest compensation for visit-related expenses. This research was recently highlighted at the annual meeting of American Society of Retina Specialists where four RIC surgeons were asked to present. A point I would like to make with significant pride is that at present, our surgeons have the largest experience of delivering stem cells to patients for AMD in the … Continue reading →

The Philippine College of Physicians urged several hospitals and medical practitioners to adhere to established standards of practice and medical ethics when they perform stem cell therapies (SCT) after they learned that there have been deviations from the three approved uses of stem cells in the country. PCP officials appealed to the Philippines's Food and Drug Administration (FDA) and Professional Regulation Commission on Tuesday to strictly enforce standards of practice involving stem cell cures and probe advertised SCT techniques, adding that the only recognized SCT as of now are: hematopoietic stem cell transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells. The PCP said all other SCT done in some hospitals and by some doctors that are not FDA-approved and are off-label, including those purported to address diabetes, autism, and HIV-AIDS must meet rigorous clinical standards and peer review. Hematopoietic stem cell transplantation for specific cancers involves the bone marrow, corneal resurfacing with limbal stem cells concerns the eyes, while skin regeneration with epidermal stem cells is used to treat severe burn cases. Dr. Carlos Lasa, a plastic surgeon, said the cosmetic and aesthetic applications of stem cell techniques have been abused and advised that … Continue reading →

It began with some Googling. Wellington woman Jennifer Jackson had learned that her Facebook friend, Mia Herranen of Helsinki, had been diagnosed with spino-cerebellar ataxia, a debilitating neurodegenerative disease that has no cure, so she began researching alternative treatments on the internet. She discovered that in places like Mexico, China and the Philippines, clinics are using adult stem cells to treat a vast array of ailments, including arthritis, diabetes, ageing, heart disease, auto immune conditions and degenerative diseases. What surprised Jackson was that stem cell therapy was happening right here - the New Zealand Stem Cell clinic uses liposuction to remove a patient's fat tissue, extracts the stem cells and implants them back into the body at clinics in Christchurch and Auckland. Herranen had been considering travelling to Mexico but the New Zealand clinic was more appealing because the method used was safer, and it was a lot cheaper - $9000 compared to as much as $50,000 elsewhere. Jackson got in touch with the clinic, and established a crowd funding site, which has so far raised more than 3000 ($5000) towards getting Herranen, 41, to New Zealand, possibly by the end of the year. The clinic's director, cosmetic surgeon Dr … Continue reading →

By RTT News, August 22, 2013, 10:35:00 PM EDT (RTTNews.com) - Cellular Biomedicine Group (CBMG) has completed patient enrollment for its phase I trial of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy in liver cancer. The company noted that it is on track to complete the phase I trial in the fourth quarter of this year. CBMG.OB closed Thursday's trading at $6, unchanged from the previous day's close. Navidea Biopharmaceuticals Inc. ( NAVB ) has reached agreement with FDA on Special Protocol Assessments for its pivotal phase III program with NAV5001, an investigational radiopharmaceutical imaging agent. NAV5001 is being developed as an aid in the differential diagnosis of Parkinsonian syndromes. The company is actively preparing for the initiation of the pivotal phase III trials for NAV5001 later this year. NAVB closed Thursday's trading at $2.96, up 3.14%. Nuvo Research Inc. (NRI.TO) said that the NDA for pain product PENNSAID 2% submitted by its business partner Mallinckrodt ( MNK ) on August 7, 2013 has been accepted for review by FDA. The regulatory decision is expected by February 7, 2014. PENNSAID 2% is an improved version of Pennsaid, a non-steroidal anti-inflammatory drug, approved to treat signs and symptoms of osteoarthritis … Continue reading →

The Summit 4 Stem Cell group will conquer Mount Everest Base Camp to raise awareness and funds for a Parkinsons disease study. Courtesy photo By Karen Billing A group of dedicated local climbers will head to the Himalayas this fall in search of an end to Parkinsons disease. As part of Summit 4 Stem Cell, 10 local residents will head to Nepal in early October to trek to the base camp of Mount Everest, an altitude of 17,598 feet, to raise awareness and funds for a unique Parkinsons disease study. The study is being done locally in San Diego, using non-embryonic stem cells and turning them into dopamine-producing neurons. The loss of dopamine production in the brain is the driving cause behind Parkinsons disease. This research is going to be so significant, said Sherrie Gould, a local nurse practitioner at Scripps Clinic Movement Disorders Center, who is leading the trek. We dont know what starts Parkinsons, but we do know that it is caused by a loss of a neurotransmitter called dopamine Its not a complete cure but if we can fill up the tank, refill the bucket with fresh new dopamine-producing cells we can essentially rid the patients of … Continue reading →