Search Results for: perinatal fda

FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells, […]

FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024 Read More »

Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis

stem cell shampoo

Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell

Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis Read More »

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

Robert Califf, FDA Commissioner

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »

Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society

Perinatal Stem Cell Society email material.

I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah

Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »

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

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 »

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

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 »

Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,

Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »

3rd Invitrx warning highlights FDA oversight weakness

The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past

3rd Invitrx warning highlights FDA oversight weakness Read More »

Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO

Timothy D. Hunt, new CEO of ARM, Alliance for Regenerative Medicine

I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an

Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO Read More »

Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees

Human-cloning

Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been

Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees Read More »