Tag Archives: Clinical trial

Adult stem cell research moving forward, but still slow

Sierra Fedelem may look like any other 20-month-old, but her parents are doing everything they can to make sure her life is just like that of any other healthy human being.
Stem cell research has stirred quite the controversy in the United States, and though the current administration’s recent policy reversal on the issue could open the markets to treatments and commercialization, it’s still an option unavailable for American patients, like Sierra, unless they’re willing to travel across the world.

“The first time the neurologist said, ‘No, you don’t realize it, she’s never going to be able to walk, talk and
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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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First U.S. stem cells transplanted into spinal cord

For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday.

Doctors injected stem cells from 8-week-old fetal tissue into the spine of a man in his early 60s who has advanced ALS, or amyotrophic lateral sclerosis. It was part of a clinical trial designed to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe (…)

Safety call over stem cell trips

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A clampdown on unproven and potentially unsafe stem cell research is being called for by an expert group.
Bionet, a group of expert Chinese and European doctors, lawyers and bioethicists, says countries throughout the world must develop more effective regulation for this emerging science (…)

They had provided a wealth of anecdotal evidence about their concerns that stem cell research was being moved too rapidly into clinical practice without proper study.
He said: “The key is informed consent. Doctors should be able to tell the patient about the short-term and long-term prognosis and the things we don’t know about the
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Austin hospital among first to test stem cells to fix broken hearts

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For patients who suffer a major heart attack, get treatment at the hospital but are left with a damaged heart, Dr. Roger Gammon of the Heart Hospital of Austin is testing a new process to reverse that damage.

Just as a Houston hospital is investigating stem cells to repair the brains of stroke patients (see yesterday’s blog), the Heart Hospital is trying out a new stem cell therapy to fix the hearts of patients who suffered their first attack.
It is one of the nation’s first hospitals to test the new therapy.

Gammon, an interventional cardiologist, is leading the clinical
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