Tag

svf
Bone Marrow-Derived Cells

Combination Cell-Based Therapies: A Very Sparse Record Except for Combo-Fat Grafting with Bone Marrow – Part Two

In the last post, I had finished covering the experimental design and describing the fluids Xing, et al. used in a study of the influence of bone marrow-derived fluid to augment fat graft survival in the rabbit. I will continue in this post with a review of the results they reported. Refer to Part One...
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Cell-Based Combo-Therapies

Combination Cell-Based Therapies: A Very Sparse Record Except for Combo-Fat Grafting with Bone Marrow – Part One

Recently, my boss, Dr. David Karli, asked me about publications or data on the use of various combinations of stem cell-derived therapies. He had been looking at websites that more often now than before are advertising cell-based combo-therapies. For example, he asked me about treating patients with a mixture of some form of embryonic stem...
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Cord Blood-Derived HCT PS

Cord Blood-derived HCT/Ps Remain ‘351 Category Products – Part Two

In the last post, I covered the rapidly expanding sales of donor cord blood-derived products, despite the fact that the FDA considers cord blood to be a biological drug, and requires companies to perform an IND to gain approval to sell cord blood units. In the previous post, I focused on a company, Invitrx, which...
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CryoStem Warning Letter

American CryoStem Gets a Warning Letter About Obvious Issues With Its Services

A lot of folks think that following the rules laid down by the FDA can be a challenge, due to the uncertainty of words used in 21 CFR 1271 or alleged ambiguities in the Agency’s guidances issued to assist stakeholders to follow the right regulatory path. But, in the case of American CryoStem Corporation (ACSC;...
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SVF Drug Violations

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

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

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

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

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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FDA Warning Letter Response and Questions

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

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

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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