Search Results for: clinicaltrials.gov

Cynata stem cell trial update: CEO Ross Macdonald interview

Koch-et-al_2016_MCA-derived-MSC-Treatment-of-Hindlimb-Ischemia-in-Mice-e1498668676851

Stem cell clinical trials have a certain gravitational pull for me as I’m always fascinated by them and since the new Cynata trial is moving forward, I recently did an interview their CEO, Dr. Ross A. Macdonald to find out more. PK: Cynata’s recently initiated clinical trial aims to treat GVHD as have other stem …

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Burt Northwestern Stem Cell MS Trial Part 2: Marketing ‘Cure’-Like Outcomes?

stem-cells-MS-Northwestern-University

Can science now cure MS in some patients with stem cells or is that near on the horizon? What about stem cells for other serious autoimmune disorders? What are the risks to patients in terms of health, money, and hope? What if patients must find $100,000 or $200,000 just to get into a clinical trial for …

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Burt Northwestern Stem Cell MS Trial Part 1: Big Promise & Tough Questions

Curing-Multiple-Sclerosis-Stem-Cells

Dr. Richard Burt of Northwestern University has been doing cutting edge research on the use of stem cells for autoimmune disorders for more than a decade. The core idea behind the work that Burt and other research teams are doing is that stem cells may have revolutionary potential to somehow counteract the autoimmunity that causes …

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Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes

Stemgenex

Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false? Do such clinics not bear any legal requirement to provide informed consent to patients? A new court ruling raises such striking questions. San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem …

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Does stem cell clinic IRB approval mean much? Insights from blinding cases

stem-cells-eyes, stem cell therapy side effects.

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)? More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it …

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NEJM paper links 3 blinded patients to US Stem Cell clinic

stem-cells-eyes, stem cell therapy side effects.

Do three blinded US Stem Cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image …

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SCOTS Study on Stem Cells for Vision: Still Questions as Patient Alleges Harm

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I’m hearing more questions from the community about alleged harm from stem cell clinics selling stem cells for a number of vision-related conditions and some concerns include the so-called SCOTS study. I first blogged about SCOTS early this year and back then I myself had questions too. Some commenters then raised concerns or questions about SCOTS in …

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What happens next with FDA & stem cells: lower your expectations?

FDA-draft-guidance

In the total the FDA has held 3 days of public meetings on stem cells in the last few weeks ranging from science to policy and hearing from many parties including patients and even stem cell clinics so the big question now is, “what happens next?” The FDA has 4 draft guidances pertaining to investigational …

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