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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SVF Sterile Procedures
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
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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FDA Warning Letter Response and Questions
In case you haven’t heard, Ms. Kristin Comella, Chief Scientific Officer of the US Stem Cell Clinic (USSCC) was the recipient of a Warning Letter from the FDA concerning her clinic’s use of collagenase to digest fat tissue from patients to produce a stem cell-containing preparation known as stromal vascular fraction (SVF). I reviewed the...
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Comella FDA Warning Letter Response
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
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
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
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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