Search Results for: peter marks

21 Stem Cell Research & Regenerative Medicine 2021 Predictions

stem-cell-crystal-ball-300x3001

In any given field of biomedical science like stem cell research and regenerative medicine, it’s very useful if you can accurately predict the future. It seems, though, that predictions are far more difficult within the more exciting and rapidly-changing fields. The field of stem cells and regenerative medicine fits that bill. Past stem cell research …

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Recommended reads: PSC, COVID, FDA pledge, sci jobs

Sarthy-et-al-eLife-2020-Fig-2

When you sit down to read science on the weekends lately, assuming you are not primarily a COVID-19 researcher, how much COVID stuff seeps into your reading? As I was going over some of this year’s recommended weekly reads posts here on The Niche, I’ve realized that an increasing amount of COVID-19 research has joined …

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Politics & FDA OK of 2 stem cell clinic COVID-19 efforts

Anand-Srivastava

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of …

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Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy

Levy-et-al-MSCs-Science-Advances

Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative …

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FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

Roya-Panah-Kosolcharoen

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day …

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MD Stem Cells purported Right To Try program

Steven-Levy-Jeffrey-Weiss, SCOTS trial

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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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm …

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Permanent injunction on clinic firm US Stem Cell is big blow to fat clinics

US-Stem-Cell-Clinic-2

Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms. US Stem had lost the case a couple weeks back, but now …

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a …

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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …

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