Bone Marrow Concentrate (BMC) Therapy in
Musculoskeletal Disorders: Evidence-Based
Policy Position Statement of American Society of
Interventional Pain Physicians (ASIPP)
Authors: Centeno Christopher J. 
Published: March 2021

Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal
disorders has become increasingly popular over the last several years, as technology has improved
along with the need for better solutions for these pathologies. The use of cellular tissue raises a
number of issues regarding the US Food and Drug Administration’s (FDA) regulation in classifying
these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in
musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous
to the musculoskeletal system and spine.
Objectives: The aim of this review is to describe the current regulatory guidelines set in place by
the FDA, specifically the terminology around “minimal manipulation” and “homologous use” within
Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional
musculoskeletal medicine.
Methods: The methodology utilized here is similar to the methodology utilized in preparation of
multiple guidelines employing the experience of a panel of experts from various medical specialties
and subspecialties from differing regions of the world. The collaborators who developed these
position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy
standards were employed in the creation of these position statements. The literature pertaining to
BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of
minimal manipulation, and homologous use were comprehensively reviewed using a best evidence
synthesis of the available and relevant literature.
Results/Summary of Evidence: In conjunction with evidence-based medicine principles, the
following position statements were developed:
Statement 1: Based on a review of the literature in discussing the preparation of BMC using
accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and
moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies
for the same surgical exemption. Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal
disorders has become increasingly popular over the last several years, as technology has improved
along with the need for better solutions for these pathologies. The use of cellular tissue raises a
number of issues regarding the US Food and Drug Administration’s (FDA) regulation in classifying
these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in
musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous
to the musculoskeletal system and spine.
Objectives: The aim of this review is to describe the current regulatory guidelines set in place by
the FDA, specifically the terminology around “minimal manipulation” and “homologous use” within
Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional
musculoskeletal medicine.
Methods: The methodology utilized here is similar to the methodology utilized in preparation of
multiple guidelines employing the experience of a panel of experts from various medical specialties
and subspecialties from differing regions of the world. The collaborators who developed these
position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy
standards were employed in the creation of these position statements. The literature pertaining to
BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of
minimal manipulation, and homologous use were comprehensively reviewed using a best evidence
synthesis of the available and relevant literature.
Results/Summary of Evidence: In conjunction with evidence-based medicine principles, the
following position statements were developed:
Statement 1: Based on a review of the literature in discussing the preparation of BMC using
accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and
moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies
for the same surgical exemption.