Category Archives: FDA Stem Cell Trials

SAN DIEGO--(BUSINESS WIRE)-- Medistem announced today Dr. Alan Lewis, the recently appointed CEO of Medistem, will be presenting at the Stem Cells on the Mesa meeting. The company will discuss its ongoing programs at creating effective treatments for cardiovascular diseases using the Endometrial Regenerative Cell (ERC), a stem cell derived from menstrual blood. The lining of the uterus is unique in its ability to create large numbers of new blood vessels monthly. We found that the cells responsible for creation of new blood vessels, the ER, are shed into the menstrual blood. The ERC have now been cleared by the FDA for clinical trials, said Dr. Lewis. Currently we are pursuing clinical trials in patients with heart failure and critical limb ischemia, an advanced form of peripheral artery disease. In both of these conditions we anticipate the production of new blood vessels will lead to therapeutic responses. The NIH has recently published that Medistem's ERC possess a unique genetic profile associated with stimulation of new blood vessel growth. The paper may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-207.pdf We are excited about the commercialization potential of these cells, given that one donor can generated 20,000 treatment doses, said Thomas Ichim, President and Chief … Continue reading →

GlaxoSmithKline Plc (GSK) is applying Shinya Yamanakas Nobel Prize-winning discovery in stem cells to identify heart risks linked to experimental drugs earlier in the development process. Yamanaka was awarded the Nobel Prize in medicine this month for his work in turning ordinary skin cells into induced pluripotent stem, or iPS, cells with the potential to become any cell in the body. That breakthrough has enabled the London-based drugmaker to study iPS cells transformed into heart-muscle cells that may be used to test compounds for cardiovascular safety, said Jason Gardner, head of Glaxos early-stage regenerative medicine research. About half of all experimental drugs fail for safety reasons, and half of those failures are due to toxic effects on the heart, Gardner said. Finding that risk even before animal testing could potentially save drugmakers millions of dollars in clinical-trial costs and better protect patients, he said. I call this a low-risk, must-do approach to stem cells, Gardner said in an interview in Upper Providence, Pennsylvania, where Glaxo has been building on research using iPS cells that began in the U.K. in 2010. Its on the verge of being used now for decision-making. Other applications include using the test, also called an assay, … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, today released a letter to Shareholders. To Our Shareholders and Potential Shareholders: InVivo has been making excellent progress in the past months and we are firing on all cylinders. I wanted to use this letter as a forum to provide an important update on how we are using InVivos resources to create and capture shareholder value. We expect the next six months to mark a major inflection point in our growth. The FDA has not put up any roadblocks or requested additional information that will delay the start of the study for the use of our biopolymer scaffolding to treat spinal cord injuries (SCI). Before the end of 2012, we expect to validate our clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application. We expect FDA approval to start the clinical study in early 2013. We are disappointed with our recent stock price performance. The 50% decline since the end of August 2012 is unwarranted and seems to have been driven by unsubstantiated internet rumors. We … Continue reading →

GAITHERSBURG, MD--(Marketwire - Oct 11, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a leading developer of biologically active regenerative therapies, today announced that safety data from the first 10 patients in the Phase II RECOVER-Stroke study of ALD-401, a unique and differentiated stem cell population derived from patients' own bone marrow, are being presented today at the World Stroke Congress in Brazil.This initial part of the study, primarily designed to assess the safety of ALD-401, showed no severe adverse events. The study was expanded to a target enrollment of 100 patients following a review of these initial data by an independent Data Safety Monitoring Board (DSMB) earlier this year. The study data are being presented today by Sean Savitz, M.D., professor of neurology and director of the stroke program at the University of Texas Health Science Center at Houston (UTHealth). Ten patients who had suffered MCA ischemic stroke were enrolled and randomized to one of two groups: 1) a bone marrow harvest followed by intra-carotid infusion of purified ALDHbr cells or 2) a sham harvest followed by sham angiography. As this is the only randomized, double-blind, intra-arterial stem cell trial of its kind in the world, … Continue reading →

NEWARK, Calif., Oct. 10, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that two papers reporting clinical and preclinical data demonstrating the therapeutic potential of the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells) for a range of myelination disorders were published in the Oct. 10 edition of Science Translational Medicine, the peer review journal of the American Association for the Advancement of Science (http://stm.sciencemag.org/). The paper by Gupta, et al. describes the encouraging results of the Company's Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a genetic myelination disorder that afflicts children. In the trial, which was completed in February 2012, four patients were transplanted with the Company's HuCNS-SC cells and all showed preliminary evidence of progressive and durable donor cell-derived myelination. Three of the four patients showed modest gains in their neurological function, which suggests a departure from the natural history of the disease; the fourth patient remained stable. Although clinical benefit cannot be confirmed in a trial without control patients, the small but measureable gains in function at one year may represent signals of a clinical effect to be further investigated in a controlled trial with more patients. The second of the two papers, by … Continue reading →

SAN DIEGO--(BUSINESS WIRE)-- Medistem Inc. (PINKSHEETS:MEDS) announced today a peer-reviewed publication led by NIH scientists demonstrating that the companys Endometrial Regenerative Cells (ERC) possess a unique genetic signature associated with production of new blood vessels (angiogenesis). The demonstration by an independent group that ERC possess a unique gene signature compared to other stem cells, and that the gene signature is associated with production of new blood vessels, is a strong validation for our programs, said Dr. Thomas Ichim, President and CSO of Medistem. These data support original publications by our group and others that have demonstrated ERC appear to be nature's regenerative powerhouse for production of new blood vessels. According to the publication, the gene encoding aldehyde dehydrogenase, a marker of stem cell potency, was expressed 39.5-fold higher in ERC as compared to bone marrow mesenchymal stem cells (MSC). Additionally, genes associated with production of new blood vessels such as MMP-3, angiopoietin, and PDGF, were expressed 29-fold, 13-fold, and 26-fold higher in ERC as compared to bone marrow MSC, respectively. Currently the majority of scientific effort in development of stem cell therapeutics is associated with bone marrow stem cells. While bone marrow stem cells have many excellent properties, the stem … Continue reading →

BY LAURA OLENIACZ loleniacz@heraldsun.com; 919-419-6636 DURHAM Stem cells from umbilical cord blood saved at 14-month-old Jase Howells birth are now being used in research to see if the cells can help his brain heal. The research is looking into the use of the stem cells to treat brain damage from hydrocephalus, a condition characterized by the buildup of fluid in the skull. His family traveled from Texas so he could receive an infusion on Tuesday at the Duke Childrens Hospital & Health Center of cord blood that was saved at his birth. Mommys so proud of you, said LeaAnn Howell, to Jase, as he lay on a hospital bed, surrounded by medical personnel and family. He periodically lifted his leg up and down to the beat of The Wheels on the Bus and other songs played by music therapist Tray Batson during the procedure. Like I said, we were going to do anything humanly possible that we can do, Howell said in an interview prior to the procedure. Its a tough thing to fly, but once we (get here), I think the results are worth the wait, I guess. The research into the use of cord blood stem cells to … Continue reading →

ROCKVILLE, Md., Oct. 9, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE Amex: CUR) announced that Eva Feldman, MD, PhD, principal investigator of the Phase I trial to test Neuralstem's NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), updated data on the trial at the American Neurological Association annual meeting in Boston, MA, yesterday. (http://www.aneuroa.org/i4a/pages/index.cfm?pageid=3311). Dr. Feldman, who is President of the American Neurological Association, presented interim results on all 18 procedures in 15 patients, including the last three patients from earlier cohorts who received second procedures. The trial will conclude six months after the last patient was treated, which was in August. (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) "This has been a very successful trial so far," said Dr. Feldman, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "With the transplantation of these neural stem cells, we are exploring a paradigm shift in the treatment of ALS. We have demonstrated that intraspinal transplantation is feasible and well-tolerated. Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in … Continue reading →

World-Class Industry Expert to Accelerate Commercialization of Universal Donor Stem Cell Drug for Heart Failure, Critical Limb Ischemia and Type 1 Diabetes SAN DIEGO--(BUSINESS WIRE)--Medistem Inc. (PINKSHEETS:MEDS) announced today appointment of Dr. Alan Lewis to the position of Chief Executive Officer and Member of the Board. Since January, Dr. Lewis has been functioning in the capacity of Scientific Advisory Board Member for Medistem. To date the Medistem team has demonstrated remarkable accomplishments by taking a stem cell from discovery to FDA clearance in the short span of 4 years, thus positioning the company as having the longest patent life among clinical-stage stem cell companies We are enthusiastic that Dr. Lewis is taking the helm to help accelerate clinical development of the Endometrial Regenerative Cell (ERC) universal donor stem cell product, which is already in Phase I and Phase II studies for critical limb ischemia and congestive heart failure, respectively, said Dr. Vladimir Bogin, Chairman of Medistem. Dr. Thomas Ichim is assuming the role as the companys President and Chief Scientific Officer. Dr. Lewis spent 15 years at the pharmaceutical company Wyeth-Ayerst, where he was Vice President of Research, leading translational research efforts in diabetes, CNS, cardiovascular, inflammatory, allergy and bone … Continue reading →

NEW YORK, Oct. 8, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), an emerging leader in the fast growing cell therapy market, announced today that data from its collaborative studies with the University of Michigan School of Dentistry further expands the therapeutic potential of its proprietary regenerative cell therapy product, "VSELSTM" (very small embryonic-like stem cells), by demonstrating bone regeneration capabilities in a study published online ahead of print1 in the journal Stem Cells and Development (DOI: 10.1089/scd.2012.0327). The paper highlights that human VSEL stem cells form human bone when implanted in the bone tissue of SCID mice. VSELs are a population of stem cells found in adult bone marrow with potential regenerative properties similar to those of embryonic stem cells. NeoStem has shown that these cells can be mobilized into the peripheral blood, enabling a minimally invasive means for collecting what NeoStem believes to be a population of stem cells that have the potential to achieve the positive benefits associated with embryonic stem cells without the ethical or moral dilemmas or the potential negative effects known to be associated with embryonic stem cells. This published controlled study, funded by NIH and led by Dr. Russell Taichman, Major Ash Collegiate … Continue reading →