fat stem cells Archives

Suit against Dr. Alvaro Skupin & Dra Nancy Alvarez over blinding at clinic is settled

September 14, 2023 September 16, 2023 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place. …

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Striking FDA Hahn & Marks JAMA pub on regenerative clinics

June 18, 2020 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 5 Comments

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other …

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In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial

January 28, 2020 December 31, 2023 / By Professor Paul Knoepfler, Ph.D. / 28 Comments

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a …

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StemGenex clinic bankruptcy reveals surprises including huge revenue

September 11, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 6 Comments

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end …

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Kristin Comella resigns from embattled clinic firm US Stem Cell

September 8, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 8 Comments

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to …

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Fallout of big court loss for stem cell clinic whose leader tweeted conspiracy claim

June 4, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case. Here is the FDA’s official reaction today to the court ruling. Also, since the ruling major media have been covering the court ruling. Here are some examples: From the Washington Post from …

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Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court

June 3, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 26 Comments

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is …

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FDA needs to quickly act against IRBs enabling risky fat stem cell clinics

March 31, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by …

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Clinic biz US Stem (USRM) may be kaput in matter of weeks or months

March 10, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 7 Comments

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further, …

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Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device

February 20, 2019 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 12 Comments

When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. …

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