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Bone Marrow Morbidity

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

Xing, et al. published a study in which they determined that bone marrow aspirate (BMA) and bone marrow concentrate (BMC) both contributed to the viability of fat grafts in a rabbit model, with some advantages demonstrated in BMC-laced grafts. I reviewed the details of the study in a series of posts, which I especially appreciated...
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Misunderstanding Bone Marrow Aspiration

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

On occasion I am asked what the FDA would think about a physician combining two therapies together. Examples of combinations might include PRP and BMC, PRP and SVF (Stromal Vascular Fraction of single cells obtained after enzymatic digestion of fat tissue), PRP and Fuzz Balls (i.e., mechanically processed lipoaspirate) or BMC and a small molecule...
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Lipoaspirate treatments

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

In the past couple of posts (Part One and Part Two of this series), I have reviewed a study by Xing, et al. in which the authors combined minced fat tissue with BMA, BMC or PBS (phosphate buffered saline) to assess the impact of each material for promoting viability of fat grafts in a rabbit...
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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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Cord Blood Derived HCT

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

Back in mid-February, I was at the IOF Conference and was a part of a panel discussing various aspects of the questionable regulatory compliance by companies selling products that contain cord blood-derived components, including viable cells, among other issues. I was shocked to learn of the extent that the free-for-all in regenerative medicine involved donor cord...
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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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RTI Warning Letter

An Oldie But a Goodie: RTI Surgical is Awarded a Warning Letter

Physicians using FDA-compliant therapies (BMC and PRP are the only ones currently) are frustrated by having to compete with over-the-line, lunch-sponsoring, media-savvy, modern day snake oil sales organizations who say whatever it will take to charge patients for receiving miracle cures. Some physicians wonder why it takes the FDA so long to deal with these...
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