Tag

therapeutic preparation
amniotic fluid therapeutic products

Implications of Using Donor-derived Exosome-laden Amniotic Fluid As a Therapy: Practical Concerns and Potential Regulatory Issues – Part Four

In the previous post, I raised the possibility that the FDA might view the presence of exosomes in amniotic fluid therapeutic products as causing the fluid to no longer be considered exempt from 21 CFR 1271, because the fluid with exosomes would no longer be considered as just a secretion. I had indicated that there were...
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Misunderstanding BMA, Minimal Manipulation

Misunderstanding BMA and a Regulatory Framework for Thinking About Combination Cell-Based Therapies – Part Four

In a paper published by Gassman, et al., the authors have made a number of groundless and puzzling statements, which I have been covering over the past few posts. Misunderstanding BMA and a Regulatory Framework for Thinking About Combination Cell-Based Therapies Series: Part One | Part Two | Part Three I will provide in this...
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Misunderstand BMA and Fat Grafting

Misunderstanding BMA and a Regulatory Framework for Thinking About Combination Cell-Based Therapies – Part Three

In the previous two posts (Part One and Part Two), I have examined comments made by Gassman, et al. in which they erroneously stated that bone marrow aspiration is painful and that it is associated with increased aspiration site morbidity. Their comments were directed at an article by Xing, et al. published together in the...
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FDA Commissioner Brings Down Hammer

The FDA Commissioner Brings the Hammer Down on Rogue Clinicians Offering “Unproven” Regenerative Medical Therapies

There has been great concern raised about a Statement the FDA Commissioner issued on November 16, 2017, due to the forceful comments he made about non-compliant physicians and clinics offering a variety of “unproven” therapies for use in treating a large number of pathologies. But what motivated the Commissioner to issue the letter last November? Consider these...
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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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PRP and Method of Ratios

Method of Ratios Applies to PRP Made by Commercial Device Technologies

My boss, Dr. David Karli, introduced the concept of the method of ratios during a talk he gave at the TOBI conference this past June. He wrote a couple of guest posts for the Blog in which he covered the field of hemoanalytics and how, in the case of PRP, a set of ratios might...
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SVF Preparation

Fuzz Balls Aren’t Equivalent to SVF in the World of Regenerative Medicine

In the previous post, I covered a material I call Fuzz Balls produced in the Lipogems System. My contention is that the Fuzz Balls can’t be used to treat orthopedic pathologies for regulatory reasons, which definitely is a minority position. I also mentioned that I had been taken to task for the somewhat tongue-in-cheek use...
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Lipogems Adipose Tissue

Lipogems Not to the Rescue

The previous post provided an introduction into what’s happening in the world of fat tissue-based therapeutic preparations in the USA. I focused on the situation in which physicians use enzymatic digestion of a patient’s fat tissue to manufacture stromal vascular fraction (SVF), which is a single cell suspension containing mesenchymal stem cells (MSCs). I ended the...
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