FDA same surgical exception comment
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FDA Interstate Commerce Regs Surprisingly Broad, Major Implications for Stem Cell Clinics
The FDA mandate to regulate drugs and devices often invokes a term called “interstate commerce”. Like many people I thought I knew what that meant, but probably like most people I was wrong. After a great discussion on an original post on various key issues related to the many stem cell clinics doing non-FDA approved
Stem cell clinics, FDA, & giant, unapproved for-profit human experiments
When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the
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FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet?
Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of
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FDA Draft Guidance Views Fat Stem Cells As Drugs
With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem
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FDA warning letter to stem cell face creams maker
The FDA has issued a warning letter to Cell Vitals, a company that manufactures and sells stem cell face creams. Cell Vitals is apparently owned by Irene Hardy according to the letter and the business has an address in Irvine, CA. A screenshot from their website is shown below. The stem cell creams sold by Cell Vitals
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FDA on Key Stem Cell Regulatory Issues & Its Own Research
It’s been a seemingly rather quiet year on the FDA regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank
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BioTime Cell Cure Files IND with FDA for ES cell AMD therapy
Stem cell biotech BioTime announced the news today that its subsidiary Cell Cure Neurosciences (Cell Cure) has filed an IND with the FDA for an embryonic stem (ES) cell-based therapy for Dry age-related macular degeneration (AMD). The product to be tested is OpRegen, which the company indicates is “the first IND for an ES cell-based
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Interview with Jane Lebkowski on Asterias FDA-approved Stem Cell Trial
The BioTime subsidiary, Asterias, has received FDA approval for a combined Phase I/IIa clinical trial of OPC1 for treating spinal cord injury. BioTime (BTX) and Asterias (ASTY) have picked up the portfolio of the former Geron clinical trial using oligodendrocyte precursor cells (OPC). Asterias also acquired a second element from Geron in the form of a lung
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Great News: FDA Nod For ViaCyte IND of Diabetes Stem Cell-Based Product
Type 1 Diabetes is a huge global problem. Where are the solutions that would compliment or replace insulin therapy for diabetics? There haven’t been too many that have gotten very far, which makes the news of a potential stem cell-based therapy moving along in the pipeline all the more exciting. ViaCyte (see more posts here,
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