Tag

LIPOASPIRATE
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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Misunderstand BMA and Fat Grafting

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

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

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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Greyledge Hemoanalytic Data

Practical Implications for Physicians Wanting to Use the Lipogems System for Processing Lipoaspirate Part One

In the last two posts (When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One andWhen Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two), I reviewed a situation involving a 510(k)-cleared device/kit for mechanically disrupting a patient’s adipose tissue (i.e.,...
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Amniotic Fluid-derived Information

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two

In the previous post When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One, I introduced what I think is a curious situation that has resulted from instructions the FDA provided to physicians on how to review the standards outlined in 1271.15(b) to see if they can invoke the...
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Lipogems Adipose Tissue

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One

During my previous review(see posts): When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two of important and relevant points the FDA made in the two Guidances that were issued on...
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