Placental Tissue-based HCT/P Products

Addressing the Flood of Placental Tissue-based HCT/P Products, Again

 In the previous post, I began a review of a marketing blurb sent to my boss, Dr. David Karli, extolling the virtues of an amniotic fluid-containing product. I am sure you are wondering why I haven’t mentioned the name of the manufacturer and the offending product, but see the explanation provided in the previous post....
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Amniotic-derived Product False Claim

Another Amniotic-derived Product Mis-states FDA Compliance

During a course offered by ASIPP last March in Las Vegas, NV, I gave a brief impromptu presentation about regulatory issues in the field of translational regenerative medicine. I mentioned that producers of placental tissue-derived products, like amniotic fluid products or amniotic fluid plus micronized amniotic tissue products, were sprouting like weeds, despite the issuing...
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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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Fat-derived SVF

Implications of the Increasing Use of FDA-non-compliant Fat-derived SVF and Fuzz Balls

While the use of adipose tissue for treating orthopedic pathologies currently is not compliant with regulations governing the manufacturing of HCT/Ps (human cells, tissues and cellular and tissue based products) in the USA, there are a lot of clinics out there, some of whom should know better, who are offering a variety of adipose tissue-derived...
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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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Health of Bone Marrow Depots

The Dynamics of Healthy Bone Marrow Depots

One theme of the last few posts on Dr. Philippe Hernigou’s pioneering use of BMC to treat soft and bony tissue pathologies has been the need to boost the bone marrow cellularity and/or its vitality. What? You haven’t caught on that the real objective of treating orthopedic pathologies is to make sure the adjacent bone...
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