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A new therapy based on embryonic stem cells will give a new hope to people who did lose their ability to move in some accident. But that’s not all, because this therapy, developed by the Geron Corp., is the demonstration that in USA, since a few days from Obama‘s election, a new course in research – above all in stem cells research – has begun.
The Food and Drug Administration (FDA) frees the medics to inject spinal stem cells extracted from embryonic tissue in legs paralysed patients since a short time. The treatment in on experimental phase, but
Medistem Inc. 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,
Drug Companies and FDA Trying to Slow Adult Stem Cell Progress
In a startling new interview on stem cell research and adult stem cells in the near future, Dr. Christopher Centeno warns that Big Pharma and the FDA are teaming to control the use of a person’s own stem cells thus slowing innovation and the […]
MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.
Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application
Christopher J. Centeno, M.D.
A leading adult stem cell therapy organization is warning the public that the Food and Drug Administration (FDA) has teamed up with the pharmaceutical industry to declare a person’s own stem cells to be a “drug” which can be regulated, thus slowing down the progress of these promising therapies by requiring years of clinical trials before use.
Dr. Christopher Centeno, of Regenerative Science, Inc. of Broomfield, Colo., realized what was happening when he was contacted by the FDA last summer about his work using a patient’s own stem cells to regenerate bone and cartilage.