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Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

January 21, 2024 / Professor Paul Knoepfler, Ph.D. / 10 Comments

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter […]

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Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more

July 3, 2018 / Professor Paul Knoepfler, Ph.D. / 6 Comments

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMATs RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with

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Tom Price & MiMedx: a stem cell connection?

January 18, 2017 / Professor Paul Knoepfler, Ph.D. / 5 Comments

What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its

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MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit

September 22, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

ABC News just reported that the FDA is allgedly “cracking down” on the publicly traded company, MiMedx (MDXG), which sells a placental derivative touted for healing powers. The Wall Street Journal is also following the story. According to ABC News: MiMedx is a publically traded, for-profit company that takes donated human placentas — solicited via a website featuring

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Big spike in FDA warning letters to unproven biologics firms

October 1, 2024 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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Regener-Eyes maker gets FDA warning on amniotic eye drops

September 12, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start

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Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions

August 8, 2023 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several

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End of FDA “grace period” impacted perinatal cell therapy biotechs

May 6, 2022 / Professor Paul Knoepfler, Ph.D. / 1 Comment

knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in

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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

September 24, 2019 / Professor Paul Knoepfler, Ph.D. / 2 Comments

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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Stem cell & regenerative medicine good news including Fate Therapeutics

January 13, 2019 / Professor Paul Knoepfler, Ph.D. / 6 Comments

In the past month or two there has been a steady stream of good news in the stem cell and regenerative medicine world. Here are three examples starting with Fate Therapeutics. Fate Therapeutics Fate Therapeutics announced the first US IND for an induced pluripotent stem cell (IPSC)-related product. Its cleared product, FT500, is an off-the-shelf

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