In the previous post: Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One, I started exploring what I think the FDA is trying to tell us stakeholders in its recently issued Guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”. I...
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The FDA issued two Guidances on November 16, 2017; one on homologous use and minimal manipulation, and the other on the Same Surgical Procedure Exception in 21 CFR 1271.15. See, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” for the text of the Guidance. Also, see...
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In my last post,  I continued my discussion about Dr. Paul Knoepfler’s “out there” heavily biased blog post on the alleged evils of stem cell clinic’s patient treatments with “…non-FDA approved offerings.” Today, I am going to discuss the importance of two recently issued FDA Guidances. For some of us, November 16, 2017 will be...
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Knoepfler on Stem Cell Clinics
In my previous post, I introduced a really out-there post by Dr. Paul Knoepfler on the evils of stem cell clinics that he claims are providing just placebo treatments. He indicated he was privy to secrets told to him by personnel at the offending clinics. However, he failed to mention the therapies he is targeting,...
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False Points about Stem Cell Clinics
Last month, Dr. Paul Knoepfler wrote a post on his Blog that was one of the most biased commentaries I have read in a long time about the alleged evils of stem cell clinics treating patients with “…non-FDA approved offerings.” The post covered secrets he claimed have been told to him by clinics over the...
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Pluripotent Stem Cells
In the previous post I had begun a review of the nature of totipotent and (real) pluripotent stem cells. I was motivated to comment on this apparently confusing area due to the ever more frequent statements patients can find on physician/clinic websites touting the miracles of being injected with what the sites claim are pluripotent stem...
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Pluripotent Stem Cell Injections
My boss, Dr. David Karli, frequently fields questions from friends, colleagues and patients about his opinion on the value for someone to receive a seemingly magical regenerative medical injection that will cure all that ails them. After I investigate the link he sends me, I usually find the words “pluripotent stem cell” somewhere in a...
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SVF Drug Violations
Previously, I wrote about several significant issues identified in the FDA’s audits of Ms. Comella’s US Stem Cell Clinic (USSCC) with respect to making stromal vascular fraction (SVF) preparations to treat patients. Needless to say, the FDA has come down hard on the USSCC operation by auditing the clinic’s protocols against a cGMP standard, which...
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SVF Preparation Process
The previous Greyledge post contained some of my observations on the issues cited in the FDA’s Warning Letter that was sent to Ms. Comella and her SVFing clinic, US Stem Cell Clinic (USSCC) on August 24th. The Warning Letter addressed substantial operational failures in the protocols Ms. Comella and her clinic have used to produce...
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