What happens if unproven stem cell clinic firms like GIOSTAR start getting okays from the FDA to do clinical trials? On the one hand, it could reflect a positive trend of stem cell clinic firms working with the FDA and toward compliance. Having more robust data.
However, I worry about some of these types of clinic okays, called investigational new drug applications or INDs. We’ve seen more of them since 2016.
Also, in the scenario of RFK at HSS and Martin Makary at the helm of the FDA (these are the nominees), what will the FDA do about clinic firms more generally?
Let’s start our weekly overview of the field there as GIOSTAR just got an IND.
GIOSTAR and the FDA
Here’s the item that got me thinking more about this again. GIOSTAR Announces FDA Clearance of the IND for Starting PHASE-2 Clinical Trial for Developing Specific Stem Cell Therapy for Type II Diabetes, PR. I have some concerns about this news. I’ve written about GIOSTAR before including its marketing of unproven stem cell approaches. From the PR:
“According to the Chairman and Cofounder of GIOSTAR, Dr. Anand Srivastava, “DT2-SCT is a cellular therapy for Type II diabetics which uses autologous stem cells, isolated from the visceral tissues of the recipients, developed to target systemic ill-effects caused by diabetes-induced pathology in patients. We are pleased to reach this milestone following extensive research and development.”
To get the IND the firm must have had some solid data so that’s something.
Yet it’s not clear to me how visceral cells, perhaps MSCs in this case, could help Type II diabetes.
I worry about GIOSTAR’s track record of selling unproven stem cells for many conditions.
Do participants have to pay to participate in the DT2-SCT trial? I hope not.
My searches of Clinicaltrials.gov found no results for DT2-SCT or GIOSTAR. I also found nothing on PubMed for DT2-SCT or for GIOSTAR related to diabetes.
Turning to cadavers for bone marrow transplants
More reads including spiking worries about NIH under Trump 2.0
- The emergence of Sox and POU transcription factors predates the origins of animal stem cells, Nat Comm. Interesting look at evolution of Sox and POUR TFs. Heard of the word “exaptation”? Look it up.
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Unproven stem cell therapies: an evaluation of patients’ capacity to give informed consent, Griffith Law Review.
BlueSky vs. Twitter (X) for science
Blast from the past
Greatest Hits: Tweets from a stem cell. Having fun a long time ago in what seems like a galaxy far far away.