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Bone Marrow Aspirations
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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Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part Two

In the previous post: Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One, I started exploring what I think the FDA is trying to tell us stakeholders in its recently issued Guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”. I...
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Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One

The FDA issued two Guidances on November 16, 2017; one on homologous use and minimal manipulation, and the other on the Same Surgical Procedure Exception in 21 CFR 1271.15. See, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” for the text of the Guidance. Also, see...
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