Category Archives: FDA Stem Cell Trials

Today I am posting Part 2 of my interview with Drs. Lander and Berman of the Cell Surgical Network. You can read Part 1 here, which is an interesting look inside the Network.The final portion of this blog post series, Part 3, will be my take on their answers and you might not be surprised that I often disagree with them. Today, the questions are focused on some very critical issues for the Cell Surgical Network including potential FDA regulatory factors for the Network, the definition of their SVF product (biological drug or not a drug), and whether homologous use (see more on homologous use here) applies to their clinical interventions. In addition, I questioned them about why patients have to pay to be part of the Network clinical trial. I also asked for their vision of the future. 1. There seem to be some divergent views on SVF. On occasion the FDA has indicated that in certain circumstances that SVF is a 351 biological drug not strictly regulated by 361 HCT/P regs, but it seems this is on a case by case basis. On the Cell Surgical Network websites it is stated unambiguously that the Network clinics do not … Continue reading →

Stem cell research continues to excite the field of MS research as a new Phase I trial involving the use of stems cells as an Investigational New Drug (IND) in MS patients has been approved by the Food and Drug Administration (FDA). The small Phase I clinical trial will investigate the safety and efficacy of autologous, mesenchymal stems cell-derived neural progenitor cells (MSC-NPs) in the treatment of progressive MS. Neural progenitor cells are cells that can develop into neurons and other nervous system cells, such as oligodendrocytes, encouraging neural repair and regeneration as evidenced in studies with mice (Harris, 2012). Mesenchymal stem cells (MSCs) are adult stem cells derived from bone marrow which can differentiate into other types of cells such as neural progenitor cells (NPCs). Autologous mesenchymal stem cells are obtained from a persons (or animals) own bone marrow. Led by Saud Sadiq, MD and Violaine Harris, PhD, researchers at the Tisch MS Research Center, formerly known as the Multiple Sclerosis Research Center of New York (MSRCNY), will be recruiting approximately 20 progressive MS patients from the existing patient population of the International Multiple Sclerosis Management Practice (IMSMP), which is the research centers clinical practice affiliate in Manhattan, to … Continue reading →

Oct 04, 2013 The Tisch MS Research Center of New York announced on August 14 that the FDA has given its approval to begin a clinical trial to use stem cells in the treatment of multiple sclerosis. Approximately 2.1 million people worldwide are affected by multiple sclerosis, a degenerative autoimmune disease that affects the nervous system and leads to myelin damage. According to Dr. Saud A. Sadiq, senior research scientist at Tisch, this is possibly the first effort in the U.S. that will investigate treatment of MS through direct injection of stem cells into the spinal fluid of patients. He says that the effort represents an exciting advance in MS research and treatment. The Tisch MS Research Center is a unique organization with a novel approach to the treatment of multiple sclerosis. Dr. Sadiq has believed for over two decades that combining high standards of clinical care with research targeted at finding the cure to MS would improve the overall standard of treatment for MS patients. In short, at the Tisch center, your researcher is your doctor. This is different from the standard model, where researchers spend the majority of their time conducting studies, trials, and lab work, while doctors … Continue reading →

Cord Blood Registry Call our Specialists Meet Heather Connecting clients to the regenerative potential of stem cell medicine Cord blood has been used for 20 years to treat more than 80 serious diseases.34 Successful treatments have paved the way for further research and today, FDA-regulated clinical trials are exploring the use of a childs own stem cells for conditions that currently have no cure. Several of these groundbreaking trials only use cord blood stem cells processed by Cord Blood Registry as a way of ensuring consistent quality. That means, saving with Cord Blood Registry gives families access to more uses and treatments. Cord blood stem cells are currently being evaluated as potential treatment for: Learn more about CBR's role in furthering stem cell research through the CBR Center for Regenerative Medicine. Dr. Michael Chez, director of pediatric neurology at Sutter Medical Center, is leading a landmark FDA-regulated clinical trial to test the use of a childs own umbilical cord blood as a therapy to improve language and behavior in children with autism who have no obvious cause for the condition such as a known genetic syndrome or brain injury. Learn more A new clinical trial will investigate using a childs … Continue reading →

Legal Policy Report No. 17 September 2013 The FDAs Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation Richard A. Epstein, Visiting Scholar, Manhattan Institute Executive Summary The current biomedical revolution has its most tangible application to ordinary people in the new cutting-edge techniques devised by individual physicians for the cure and palliation of chronic and degenerative diseases. The rate of advance in this area is a testimony to the creative forces unleashed by the decentralized control over medical procedures. But that progress is now threatened by the federal Food and Drug Administration (FDA), which seeks to extend its statutory authority to subject these practices to the same oversight that is given to large drug manufacturers in the design and production of new products for the mass market. One area over which the FDA has asserted its power is private adult stem-cell treatment, which has developed treatment protocols that were not possible a generation, or even a decade, ago. The FDA has taken the aggressive position that it has oversight authority over any stem-cell procedure that reinjects harvested stem cells into the same person from whom they were removed, so long as those cells were grown and cultured … Continue reading →

Home Newsroom News Releases FDA Approves Continuation of ALS Stem Cell Trial Oct.21, 2011 Jonathan Glass, MD Nicholas Boulis, MD Emory University researchers have received approval from the Food and Drug Administration (FDA) to advance to the next phase of a landmark trial to treat patients with Amyotrophic Lateral Sclerosis (ALS) using human neural stem cells. The Phase I trial, currently underway exclusively at Emory University, is designed to assess the safety of implanting neural stem cells into the spinal cord in up to 18 people with ALS and began in January 2010. The first 12 patients received neural stem cell transplants in the lumbar, or lower, region of the spinal cord. After reviewing safety data from these patients, the FDA has granted approval for the trial to advance to the final two groups of patients (three in each group), all of who will be transplanted in the cervical, or upper, region of the spinal cord. This represents a major accomplishment for the trial, meaning that we have achieved our stated goal of proving safety in the first 12 patients who received lumbar spinal injections, says Jonathan Glass, MD, Professor of Neurology, Emory School of Medicine and director of the … Continue reading →

A recent news report released by the FDA announced the approval of a groundbreaking new study. The basis of the study utilizes advancements in stem cell use to treat multiple sclerosis (MS.) This trial is being performed by Tisch MS Center of New York research teams. Phase one of the trial follows ten years of research. New Hope for a Cure If this FDA approved trial is successful in its goals, it portends the beginning of further investigation into new FDA drug approvals. The goals of the study intend to provide clear conclusions of several factors: The study was performed with the assistance of twenty MS patients who had previously been enrolled in R&D trials and studies. This particular study gives new hope to hundreds of thousands of Americans afflicted with multiple sclerosis. The CDC reports that at least two hundred people will be diagnosed with multiple sclerosis every week. Use of Stem Cells Is Critical From early studies performed on patients with other autoimmune diseases, stem cell research has become an acceptable and feasible method of treating certain diseases believed to be incurable. In some cases, multiple sclerosis patients can experience chronic symptoms. The most serious are advancing paralysis … Continue reading →

Could skin tissue hold promise for treating Multiple Sclerosis?(30/10/13) Researchers in Milan, Italy reported that stem cells derived from mouse skin tissue were able to reduce nervous system damage in mice with a disease similar to multiple sclerosis, offering further evidence for the possibility that stem cells from patients might in the future be used for cell therapy to treat MS. The study, by Cecilia Laterza, Ph.D., Gianvito Martino, MD and colleagues at the San Raffaele Scientific Institute, Milan, and the University of Milan, was published today in Nature Communications. The study was co-funded by the National Multiple Sclerosis Society, Multiple Sclerosis Italian Foundation (FISM), MIUR Lombardy Region (NetLips Project), ELA Foundation, BMW Italy and NEUROKINE network (EU Framework 7 ITNproject). Current therapies for MS reduce the immune system attacks that damage the brain and spinal cord, but they are not effective in progressive phases of the disease, when damage to the protective myelin coating on nerve fibers and the nerve fibers themselves may be widespread. Finding ways to repair the nervous system to restore function is a major research priority. For this study the team used mouse skin stem cells and forced them through "cell reprogramming" to become myelin-making … Continue reading →

ANN ARBOR, Mich. For nearly two years, University of Michigan neurologist Eva Feldman, M.D., Ph.D. has led the nations first clinical trial of stem cell injections in patients with the deadly degenerative disease known as amyotrophic lateral sclerosis, often called ALS or Lou Gehrigs disease. Now, a new approval from the U.S. Food and Drug Administration paves the way for U-M to become the second site in the trial, pending approval of the U-M Institutional Review Board. To date, the first phase of the trial has taken place at Emory University, with Feldman serving as principal investigator. The FDA approval of a Phase II trial was announced today by Neuralstem, the company whose product the trial is testing. The Phase II trial will continue to evaluate the safety of the stem cell injections, delivered directly into patients spinal cords in escalating doses of up to 400,000 cells per injection, with a maximum of 40 injections. It will also assess any signs that the injections might be impacting patients ALS symptoms or progression. Dr. Feldman discusses the FDA approval Feldman serves as an unpaid consultant to the company, and has led the analysis of results from the Phase I trial. In … Continue reading →

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (OSIR), issued a statement today correcting certain inaccuracies in media reports following the announcement of its favorable agreement with the United States Food and Drug Administration (FDA) regarding Grafix. It should be noted that Osiris may not be aware of and may not correct all current or future inaccuracies in media reports. About Osiris Therapeutics Osiris Therapeutics, Inc. is the leading stem cell company, having developed the worlds first approved stem cell drug, remestemcel-L, for graft versus host disease. Osiris products include Grafix and Ovation for acute and chronic wounds, Cartiform, a viable cartilage mesh for cartilage repair and the latest addition to Osiris line of products, OvationOS, a viable bone matrix. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology and commercial interests. Osiris, Grafix, Ovation and Cartiform are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIR-G) Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words … Continue reading →