Tag

bone marrow aspiration
BMC via IV Therapy

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part Three

Over the previous couple of posts, I have been reviewing the love/hate relationship the FDA seems to have with therapy provided by an IV route. They issued a blanket determination in the MM/HU Guidance that IV therapies of HCT/Ps would be considered risky and therefore physicians offering IV therapies of HCT/Ps would be more rapidly...
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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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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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Winners and Losers Emerge at Long Last After the FDA Issues Two Guidances

In my last post,  I continued my discussion about Dr. Paul Knoepfler’s “out there” heavily biased blog post on the alleged evils of stem cell clinic’s patient treatments with “…non-FDA approved offerings.” Today, I am going to discuss the importance of two recently issued FDA Guidances. For some of us, November 16, 2017 will be...
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Amniotic Fluid-derived Information

The Astonishing Mis-information Being Shared on Amniotic Fluid-Derived Products – Part Two

I would like to finish up with my review of outrageous mis-information being spread about by some advocates of amniotic fluid-derived products. My focus has been on a Powerpoint presentation (PPt) made available to the public by Dr. Davidson. So far, I have pointed out what I contend are discrepancies in some of his statements,...
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Bone Marrow and MSCs Through the Ages

Hernigou and Bone Marrow-Derived MSCs Through the Ages

There are a lot of folks going around saying that you suffer a dramatic loss of bone marrow stem cells (the mesenchymal stem cell [MSC] version) from your body’s bone marrow depots as you age. Which is true to a certain extent, but, as usual, the devil is in the details. Some of those who...
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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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