FDA : Stem Cell Cite

Posted by admin on February 13, 2013 Leave a Comment

By offering unproven therapies, a Texas biotechnology firm has sparked a bitter debate about how stem cells should be regulated. David Cyranoski 13 February 2013 Ann McFarlane is losing faith. In the first half of 2012, the Houston resident received four infusions of adult stem cells grown from her own fat. McFarlane has multiple sclerosis (MS), and had heard that others with the inflammatory disease had experienced improvements in mobility and balance after treatment. The infusions which have cost her about US$32,000 so far didnt help, but she knew that there were no guarantees. It is McFarlanes experience with Celltex Therapeutics, the company that administered the cells, that bothers her. She was told

Filed under Headlines, Multiple Sclerosis, Stem Cell Regulation, Stem Cells, Texas, World News Tagged with Celltex Therapeutics, FDA, Leigh Turner, multiple sclerosis, Parkinson's, stem-cell tourism

Posted by admin on August 15, 2012 Leave a Comment

Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived fromand later put back intoa person? A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier, head of FDA practice at the law firm Sidley Austin LLP, argues FDAs efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent and potentially promising industry. At issue, write Gottlieb and Klasmeierboth of whom have an admitted financial interest in stem cell therapiesis a recent court case decided in favor of FDA by the US

Posted by admin on July 26, 2012 Leave a Comment

Its official: stem cells are drugs. At least, thats the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice not regulated by the US government. But if the cells are subjected to more than minimal manipulation, the FDA maintains that the therapy becomes a drug, which must be specifically approved for use. It was on this basis that in 2008 the FDA began moves to shut downRegenerative Sciences,

Posted by admin on July 26, 2012 Leave a Comment

Animal trials of Mesoblasts (ASX:MSB) mesenchymal stem cells in rheumatoid arthritis (RA) have encouraged the company press on with an FDA application for a phase II trial. Mesoblast (ASX:MSB) is continuing to expand the applications for its off-the-shelf stem cell technology by pushing forward to conduct a phase II trial for rheumatoid arthritis (RA). This follows encouraging results from preclinical trials of its adult stem cells in animal models of RA. The company revealed that a single injection of its mesenchymal precursor cells (MPCs) was able to simultaneously inhibit multiple cytokines responsible for driving RA. The MPCs concomitantly affected T cells, monocytes and synoviocytes to shut down TNF-alpha, IL-6 and IL-I7 cytokine pathways in sheep

Posted by admin on July 10, 2012 Leave a Comment

New Therapy for Heart Attack Patients Approved by FDA for Clinical Trials San Francisco, CA A new approach using stem cells to repair the damage caused by heart attacks has been given approval for first-in-human use in clinical trials by the Food and Drug Administration. Funding for research that contributed to the potential therapy came from Californias stem cell agency, the California Institute for Regenerative Medicine (CIRM), through a Disease Team grant to Cedars-Sinai Heart Institute in Los Angeles. This is the first time that research by a CIRM-funded Disease Team has resulted in an Investigational New Drug (IND) approval from the FDA, a critical step in testing promising therapies in patients, says Ellen

Filed under Headlines, Heart Attacks, Heart Disease, Stem Cells Tagged with California Institute for Regenerative Medicine, Cardiosphere Derived Cells, CDCs, Cedars-Sinai Heart Institute, CIRM, Eduardo Marbn, Ellen Feigal, FDA, IND, Robert Quint

Posted by admin on May 27, 2012 Leave a Comment

FDA approved biologics license application (BLA) for cord blood hematopoietic progenitor cells, manufactured by Clinimmune Labs, University of Colorado Cord Blood Bank. This is a second licensed cord blood product in US, after Hemacord. Related Post FDA Okays 1st Cord Blood Product Recommend on FacebookTell a friend

Posted by admin on November 1, 2011 Leave a Comment

The FDA requires the use of a Good Manufacturing Practice (GMP) facility for taking stem cell-based therapies into clinical trials. This GMP facility is a clean-room laboratory that ensures the therapeutic products will be safe and contamination-free for patients. In Spring 2008, CIRM gave $272 million for the construction of twelve stem cell research facilities in California. The University of California, Davis was one of the recipients of this Major Facilities grant. Their $20 million award is supporting construction of the new Institute for Regenerative Cures. This 60,000 square foot building will include a state-of-the-art GMP facility. Jan Nolta is the director of the UC Davis stem cell program and Institute for Regenerative Cures. Gerhard

Posted by admin on October 25, 2011 Leave a Comment

Investigational or experimental drugs are new drugs that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use, and are in the process of being tested for safety and effectiveness. Patients may decide to seek access to investigational drugs for different reasons.Some patients with serious or life-threatening illnesses seek treatment with investigational drugs if FDA-approved therapies are not working or if their side effects are too severe.Others may have heard about promising early study results for a specific investigational drug, and they might want to learn more. Investigational drugs are available through two pathways designed to protect patients, because an investigational drug may pose

Posted by admin on October 22, 2011 Leave a Comment

AUSTIN, TexasDoctors at Heart Hospital of Austin and Austin Heart, one of the largest non-academic cardiovascular research departments in the United States, are working to identify patients for a clinical trial to investigate a therapy that would allow physicians to treat patients with severe Peripheral Arterial Disease (PAD) using adult stem cells harvested from a patients own body. The study will focus on patients with critical limb ischemia, a severe blockage in the arteries of the lower extremities that significantly reduces blood flow, a condition that often results in amputation. This groundbreaking research may open doors to new treatment strategies for a wide range of cardiovascular conditions and offer hope for patients with end-stage disease,

Posted by admin on October 22, 2011 Leave a Comment

Global regenerative medicine company Mesoblast Limited (ASX:MSB; OTC ADR: MBLTY) today announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase 3 clinical trial for bone marrow regeneration in patients with blood cancers. FDA clearance was obtained within the 30-day minimum time period after Mesoblast filed its Phase 3 Investigational New Drug (IND) submission. The Phase 3 trial will aim to reproduce the positive pilot trial results seen at the University of Texas MD Anderson Cancer Center, where accelerated neutrophil and platelet recoveries, together with excellent 100-day patient survival and low GVHD rates, occurred in patients receiving partially mismatched hematopoietic cells from umbilical cord blood expanded

Filed under Blood, Cord Blood, Stem Cells, Texas, Texas Research, World News Tagged with allogeneic, bone marrow transplantation, FDA, hematopoietic stem cell, IND, Investigational New Drug, MD Anderson, mesenchymal precursor cells, Mesoblast, Orphan Drug Designation, Phase III, stem cell, The University of Texas, umbilical cord blood

Posted by admin on October 20, 2011 Leave a Comment

Harvest Technologies Announces FDA Approval of Its Pivotal Randomized, Controlled, Double Blind Multicenter IDE Trial Using Autologous Adult Stem Cells to Treat Patients With Non-Reconstructable Critical Limb Ischemia PLYMOUTH, Mass., March 22, 2011 /PRNewswire/ Harvest Technologies Corp. (www.harvesttech.com) announced today that the FDA has approved the company sponsored 210-patient IDE clinical trial to be conducted at twenty-five sites in the U.S. using the companys proprietary Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI). Mark D. Iafrati, M.D. Chief of Vascular Surgery at Tufts Medical Center in Boston is the trials Principal Investigator. If the pivotal study confirms these findings this would be a dramatic affirmation of the

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FDA : Stem Cell Cite