Misunderstanding BMA, Minimal Manipulation
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
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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Bone Marrow Morbidity
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
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
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
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
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
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
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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