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

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 given the fact that they performed the study on an autologous basis, since that is how humans are treated with fat grafts.

Combination Cell-Based Therapies Series: Part One | Part Two | Part Three

However, lipofilling in humans occurs in subcutaneous tissues (e.g., the back of your hand or the face), while the Xing, et al. fat grafts were implanted into the ears of rabbits. This was done for a variety of quite valid reasons. So, I believe the observations from the study have bearing on studies in the human literature involving fat-derived therapies, as explored in Combination Cell-Based Therapies: A Very Sparse Record Except for Combo-Fat Grafting With Bone Marrow – Part Three. In the last post,  I had started to review statements made by Gassman, et al. in a paper entitled “Discussion: Improvement of Fat Graft Survival with Autologous Bone Marrow Aspirate and Bone Marrow Concentrate: A One-Step Method” . Their article was a discussion of various aspects of the article by Xing, et al.

Gassman, et al. started their critique of Xing, et al. with a concern about the pain associated with bone marrow aspiration, which I rebutted in the previous post. Their next baseless comment concerns donor-site morbidity, in which they stated that patients might not want to undergo the bone marrow aspiration procedure due to “…increased morbidity”. As immortalized by Les McCann: compared to what? Perhaps the authors think that performing more lipoaspiration and lipofilling procedures after fat graft failure are free of morbidity. Clearly, medical procedures, including lipoaspiration and lipofilling, have some level of morbidity. However, to provide context on the issue of bone marrow aspiration morbidity, I will review the data published by Dr. Hernigou on the topic.

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

One type of morbidity is associated with nerve damage. Herngiou, et al. reported that 0.6% (n=3) of the patients experienced nerve damage during the six-month period following their bone marrow aspiration. Hernigou et al. also reported on minor complications associated with bone marrow aspiration, which include superficial hematoma, seroma, and superficial infection. Approximately 2% of patients experienced one of these minor complications. The patients experiencing minor complications were treated with appropriate non-surgical wound care, and all complications resolved. Finally, 0.6% (n=3) of the patients experienced a major complication. Two patients had deep-seated hematomas, which were treated by transfusion (without surgical intervention for drainage) and the other patient suffered a non-displaced fracture at the donor site three days after the bone marrow aspiration. The three patients with major complications healed without further issues.

Obviously, no medical procedure is without the potential for an adverse event. This applies to any medical procedure including liposuction, fat grafting (e.g., lipofilling), and bone marrow aspiration. But if certain precautions are taken, and the aspirator is trained in the procedure, the morbidity of a bone marrow aspiration is very low. Also, keep in mind that Dr. Hernigou tends to aspirate fairly large volumes of bone marrow for his surgical procedures (>120 mL), while augmenting a fat graft would require less volume to be aspirated.

In addition to the Hernigou reference mentioned above, he and his colleagues have published two papers that explicitly deal with the anatomy of the iliac crest and how to approach performing a bone marrow aspiration from the ilium. The papers are entitled:

Understanding bone safety zones during bone marrow aspiration from the iliac crest: the sector rule” and “Anatomy of the ilium for bone marrow aspiration: map of sectors and implication for safe trocar placement”. The point is bone marrow aspiration has made a lot of progress in the time since the authors of the Gassman, et al. paper probably were first exposed to a BMA procedure way back when. What is puzzling is that an easy key word search would have brought up the Hernigou papers and the authors could have been better informed on the topic.

However, I am not sure how they could have avoided some of mistakes they made on regulatory aspects of combining fat grafts and bone marrow that I will point out in the next post.

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