Tag

cell therapy
Knoepfler on Stem Cell Clinics

Creating a Storm Without Enlightening Anyone: Paul Knoepfler Shares His Frustrations with Stem Cell Clinics – Part Two

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

Creating a Storm Without Enlightening Anyone: Paul Knoepfler Shares His Frustrations with Stem Cell Clinics – Part One

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

What’s Up with All of the So-Called Pluripotent Stem Cell Injections Everyone is Getting? Part Two

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

What’s Up with All of the So-Called Pluripotent Stem Cell Injections Everyone is Getting? Part One

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 Sterile Procedures

FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part Six

Of the previous five posts in this series, there were two posts (Part One and Part Two) on the Warning Letter received by Ms. Kristin Comella, which the FDA issued on August 24th, followed by three more posts (Part Three, Part Four, Part Five) on the questions Ms. Comella included in a stunningly blunt diatribe...
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FDA Warning Letter Rebuttal Responses

FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part Five

So far, I have written two posts (Part One and Part Two) on the Warning Letter received by Ms. Kristin Comella, which the FDA issued on August 24th, followed by two more posts (Part Three and Part Four) on the questions Ms. Comella included in a breathtakingly blunt diatribe against the FDA that she issued...
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Comella FDA Warning Letter Response

FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part Three

My original plan for this post series was going through the FDA’s Warning Letter issued to Ms. Comella, Chief Scientific Officer of the US Stem Cell Clinic (USSCC), on August 24th to review adverse findings the FDA published on the conditions and quality issues they found during their auditing visits. If you want to get...
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FDA Warning Letter to Party Creating SVF Drug

FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part Two

Note: After the previous post was queued up for last Wednesday’s release, US Stem Cell Clinic issued an extraordinarily lengthy, and at times unfocused, rebuttal to the actions taken by the FDA against the clinic. I will review this incredibly in-your-face diatribe against the FDA in the next three posts. However, there was a statement...
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Treating Patients with Fat Tissue-derived Stem Cells

FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part One

Last Thursday, the FDA issued a Warning Letter to Ms. Kristin Comella, Chief Scientific Officer (CSO) of US Stem Cell Clinic, LLC (USSCC). And although it looks like your run-of-the-mill letter it actually is a hammer—a FDA hammer. The recipient, USSCC, is a subsidiary of US Stem Cell, LLC, for which Ms. Comella also is...
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Degenerative Disc Disease Treated with BMC

BMC as Degenerative Disc Disease Treatment – Part Four

The focus of the previous three posts (Part One, Part Two, and Part Three) has been on reviewing various aspects of a paper recently published on the three-year milestone data of a clinical study in which study subjects had their own BMC injected into a 1-level or 2-level degenerative disc pathology in an attempt to...
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