Search Results for: perinatal

Weekly reads: brain aging, perinatal stem cell clinics, $1M lab meat fine bill

February 17, 2024 / By / 1 Comment
brain aging

What happens during brain aging and how can we tell if dementia is coming? Are there particular early hallmarks? There are an increasing number of medical tests for predicting or detecting dementia. Alzheimer’s disease can often be detected early. But what do patients or their doctors do with such information? Until recently there weren’t any …

Weekly reads: brain aging, perinatal stem cell clinics, $1M lab meat fine bill Read More »

FDA warns Neil Riordan U.S. perinatal firm Signature Biologics

October 8, 2023 / By / Leave a Comment
Signature Biologics, Neil Riordan

Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama  clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the …

FDA warns Neil Riordan U.S. perinatal firm Signature Biologics Read More »

FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity

August 31, 2023 / By / 7 Comments
Dr. Leonid Macheret, FDA warning

Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this …

FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity Read More »

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

May 5, 2022 / By / 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 …

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

Bad Batch podcast’s dark picture of perinatal stem cell industry

March 2, 2022 / By / 4 Comments
John-Kosolcharoen-Liveyon-Bad-Batch

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have …

Bad Batch podcast’s dark picture of perinatal stem cell industry Read More »

FDA warns another perinatal stem cell supplier Stemell

February 1, 2021 / By / 1 Comment
Stemell-logo

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain …

FDA warns another perinatal stem cell supplier Stemell Read More »

Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry

June 8, 2022 / By / 1 Comment
Liveyon

The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that  in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow …

Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry Read More »

Key Mayo Clinic stem cell webpage is overexuberant & outdated

March 30, 2024 / By / 2 Comments
The Mayo Clinic.

The Mayo Clinic does some great research on stem cells and regenerative medicine. However, at times I’ve felt that a few Mayo researchers are overexuberant. This mainly relates to certain not-yet-proven stem cell and related offerings. Fitting with that perception, the Mayo website also has some inaccurate stem cell content that leans toward overstating things. …

Key Mayo Clinic stem cell webpage is overexuberant & outdated Read More »

Man could get 240 yrs for amniotic fluid for knees Medicare scam

February 6, 2024 / By / 3 Comments

A Justice Department press release details how a physician’s assistant (PA) in Texas was convinced of fraud related to amniotic fluid injections. This story tells us some important things about how Medicare handles things versus the FDA approach to such things. Amniotic fluid scam A jury found Ray Anthony Shoulders, a PA at a pain …

Man could get 240 yrs for amniotic fluid for knees Medicare scam Read More »

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

January 21, 2024 / By / 10 Comments
AXIOFILL, MiMedx

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 …

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