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Complications and unanticipated side-effects that have slowed the progression of stem cell studies from the lab to the clinic could soon change, researchers say.
For a decade, stem cells have tantalized scientists and patients with their promise to regenerate damaged tissues and offer treatments for incurable diseases.
No one hears, however, about the individuals who died due to complications of surgery, said Dr. Hans Keirstead, a Canadian researcher who made a paralyzed rat walk back in 2004 by injecting its spinal cord with cells derived from human embryonic stem cells.
Keirstead’s lab at the University of California-Irvine just received approval
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.
Stem Cell Therapeutics Corp. is pleased to announce the U.S. Food and Drug Administration (FDA) has provided a verbal confirmation to remove its clinical hold placed on NTx®-265 on September 18, 2008. This will allow SCT to commence the recruitment of patients under an amended protocol using NTx®-265 for the Company’s Phase IIb clinical trial treating acute ischemic stroke.
Dr. Alan Moore, President and CEO, commented as follows:
“We are very pleased that our series of collaborative meetings with the FDA has resulted in this positive development. We are expecting to receive written notification from the FDA in the near future
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