Tag Archives: US Food and Drug Administration

FDA Violates Mandate – Unauthorized Change Undermines Most Promising Stem Cell Research

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.

“The FDA
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Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial

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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Graft Vs Host Disease Stem Cell Treatment Made Available

Prochymal Adult Stem Cell Therapy Available For Graft Vs Host Disease
Lost amidst the Adult stem cell company Osiris’ latest press release announcing their 1rst quarter results for 2009, was a revelation that revealed that their “off the shelf” stem cell product, Prochymal, was given approval by the FDA to be used as a stem cell […]

Stem Cell Research Saves Diabetes Patient’s Leg From Amputation

Victory for Adult Stem Cell Research- Saves a Man’s Leg
Tom Fisher already had his  right leg amputated due to complications from Diabetes and he was in danger of losing his left leg as well.  However, stem cell research in the form of Adult Stem Cells has saved his leg from amputation and have healed all his […]

US Patients Battle the FDA Over Use of Their Own Cells

American Doctors and Patients Challenge the FDA to Save Lives Rather Than Allow Patients to Needlessly Die
A couple of weeks ago, the American Stem Cell Therapy Association (ASCTA) was formed by a group of doctors, not to debate the pros and cons of embryonic stem cell research and adult stem cell research, but to […]