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15 still unanswered interview questions for stem cells for vision SCOTS trial docs

May 29, 2018 May 17, 2023 / By Professor Paul Knoepfler, Ph.D. / 4 Comments

George-Gibson-SCOTS-patient-screenshot-of-Sun-Sentinel-video-1

What is the SCOTS Trial and why are some of its participants raising concerns? There’s a lot going on in Florida with non-FDA approved stem cell offerings. Even just related to stem cells for vision problems alone. While US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida …

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

April 3, 2017 March 17, 2023 / By Professor Paul Knoepfler, Ph.D. / 6 Comments

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

November 21, 2016 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

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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Overplaying N=1 in the stem cell therapy world

May 17, 2022 May 16, 2022 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

The regular emails and phone calls I get from patients asking questions about stem cell therapy are a powerful reminder of the fact that research in our field can be very personal. Sometimes individuals who receive experimental stem cell therapy (or other cell therapies) and seem to have a positive outcome can end up becoming …

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MD Stem Cells purported Right To Try program

November 3, 2019 February 15, 2022 / By Professor Paul Knoepfler, Ph.D. / 14 Comments

I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that …

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New lawsuit against U.S. Stem Cell also alleges blindness

December 21, 2017 May 12, 2023 / By Professor Paul Knoepfler, Ph.D. / 4 Comments

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

A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart). American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of …

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Sentinel Takes Investigational Deep Dive into Florida Stem Cell Clinic Soup

December 11, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 12 Comments

When you think of Florida, what else crosses your mind first? Orange juice? Heat and humidity? Beaches? Disney? I don’t know if this says more about me or the state, but these days I think of stem cells. Florida and California are the two biggest hotbeds of the for-profit stem cell clinic world, each with …

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New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network

September 28, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 5 Comments

Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The …

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

March 23, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 15 Comments

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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