Tag

orthopedic surgical treatments
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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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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BMC as Alternative for TKA

BMC as an Alternative to TKA and Rotator Cuff Support in the Elderly

I disposed in the previous post of the notion that you lose all of your bone marrow-based MSCs if you are elderly. That conclusion is based on one of Dr. Philippe Hernigou’s presentations during the recent national ASIPP conference. Dr. Hernigou is the pioneering physician who has been working with bone marrow concentrate (BMC) for treating...
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BMC Treated Allograft

BMC Supercharges Allograft for Better Outcomes in Hips with Swiss Cheese-like Holes

In the previous post, I reviewed results reported by Dr. Philippe Hernigou about the significant loss of MSCs and satellite cells (the stem cell in the muscles) from the tissue of patients who had received a certain kind of implant liner in their primary total hip replacement. The publication showed that patients with the largest...
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Bone Marrow Depot and Hip Replacement

The Importance of Healthy Bone Marrow Depots in Hip Replacement Patients

One of the important lessons embedded in the clinical results Dr. Philippe Hernigou has published in a dozen or so papers on the benefits of using bone marrow concentrate (BMC) in treating orthopedic pathologies is that having a healthy bone marrow depot close to the site of pathology will aid in restoring/repairing the orthopedic injury....
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Avascular Necrosis

Hernigou Pioneered BMC Treatment of Avascular Necrosis of the Femoral Head

In the last post,I reviewed the therapeutic benefit reported by Dr. Philippe Hernigou for using BMC to treat ankle non-unions in diabetic patients. I will move on in this post to cover Dr. Hernigou’s use of BMC in another bony pathology, namely avascular necrosis of the femoral head, also referred to as osteonecrosis of the...
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Non-unions in Diabetic Patients

Hernigou Closes the Gap on Diabetic Foot/Ankle Non-unions

In the last post, I reviewed the potent anti-microbial benefits of bone marrow concentrate (BMC) published in a paper by Dr. Philippe Hernigou in treating antibiotic-refectory infections in non-unions. I will move on in this post to cover Dr. Hernigou’s use of BMC in treating non-unions of the foot and ankle in diabetic patients. I...
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Stem Cell

Making Sense of Your Environment—if You are a Stem Cell

In a previous post, I commented on a paper recently published in the New England Journal of Medicine (NEJM) in which FDA personnel expressed their dissatisfaction with the lack of solid, Level 1 clinical trials for the use of stem cell therapies by citing the lack of systematic recording of adverse events and a lack...
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