FDA: NeuralStem's Fetal Stem Cell Study for Lou Gehrig's Patients on Hold |
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Editors published 2/25/2009 9:50:00 AM
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Source: Neuralstem clinical trials put on hold Vandana Sinha , BizJournals.com
The US FDA put a hold on NeuralStem's clinical study amyotrophic lateral sclerosis, more commonly known as Lou Gehrig’s Disease.
The company had intended to test its ability to safely inject fetal stem cells into the spinal cords of patients and fully replace the damaged spinal cord cells.
See First Human Trials for Stem Cell Therapy on Lou Gehrig Patients
Looks like President Obama is side-stepping these more controversial fetal stem cells for the time being.
The FDA said it needed more information about Neuralstem’s manufacturing capabilities, animal studies and injection methods for treatment, said Richard Garr, the chief executive officer.
In addition, the agency has asked the company to modify its proposed protocols for the Phase 1 study, including a patient’s eligibility to participate and the timing of the surgeries. Neuralstem had asked for permission to test the treatment on 15 ALS patients.
While the questions are extensive, they are answerable “in an expeditious manner,” Garr said. Still, the move delays Neuralstem’s ability to take its spinal cord technology, which recently received a patent, to the next level.
In contrast, the FDA made history last month when it approved a California biotech’s similar bid to begin testing a stem cell treatment in humans for the first time to help heal traumatic spinal cord injury.
Of course, the Geron study approved last month (see FDA Approves World's First Embryonic Stem Cell Therapy in Humans. Will They Walk Again? uses embryonic stem cells previously authorized by George Bush - not more controversial fetal stem cells.
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