Search Results for: stem cell clinics

Mesoblast gets FDA RMAT; List of 10 total designations so far

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Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting […]

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Scientist’s dilemma: find a public voice on big issues or stay silent?

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Scientists-Dilemma

There is a scientist’s dilemma: should you speak out on important, sometimes controversial issues in science, where you not only can potentially have positive impact, but also risk being attacked for it? Or do you remain silent? I’ve now been blogging for more than 7 years. I’ve battled the often exploitive for-profit stem cell clinics

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Dr. Jeffrey Weiss, SCOTS trial, & Patient Claims of Blindness

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Two physicians are central to something called the SCOTS trial, Dr. Jeffrey Weiss and Steven Levy. Patients have claimed negative outcomes after participating in the trial. What’s going on here? SCOTS trial The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning. More information has come out on negative

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Federal judge blocks FDA action on Texas amniotic supplier

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The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the

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REGROW Act 2.0 still no-go with big risks to patients & field

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The REGROW Act is a bill that seeks to lessen the regulatory burden to accelerate getting stem cells to patients more quickly, but it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole. The REGROW Act, which is sponsored by Senator Mark

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Huge clinical trial fees allowed by FDA at times, details often secret

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Why can there be huge clinical trial fees for participants? I am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective. But

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Review of Centeno MSC safety paper: without controls, conclusions muted

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Centeno-Table-3

The number of people around the world being injected with stem cells every day has never been higher and the heterogeneous group of medical providers doing these procedures is also at or near its highest level ever. The cells used are also highly variable as are the procedures themselves, but most of these cells fall under the

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