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Minimally-invasive

cellular procedures in a research-focused setting

BH Cellular Medicine is a physician‑led practice that evaluates emerging approaches in regenerative medicine. Our clinical services focus on individualized assessment, patient education, and participation in appropriate treatment pathways.

© Copyright C. Bertolotto MD and S. Heneidi MD. All rights reserved.

WELCOME

Welcome to BH Cellular Medicine. Our physicians provide consultations to discuss your medical history, current diagnoses, and conventional treatment options. In selected situations, and only where consistent with applicable US regulations, we may discuss the possibility of cellular procedures that use a patient’s own cells.

These cellular approaches are considered investigational for most diseases and conditions and are not approved by the US Food and Drug Administration (FDA) to diagnose, treat, cure, or prevent any disease. Any potential risks, uncertainties, and alternative options are reviewed in detail during a clinical consultation.

TECHNOLOGY THAT TRANSCENDS
Regenerative Medicine

After a comprehensive clinical evaluation, our physicians may consider procedures that use a patient’s own cells. These cells are processed under sterile conditions. These approaches are part of an evolving field of regenerative medicine and are the subject of ongoing research to better understand their safety profile and potential effects. 

Any cellular procedures performed at BH Cellular Medicine are conducted in accordance with applicable US laws and regulations. 

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© Copyright C. Bertolotto MD and S. Heneidi MD. All rights reserved.

Innovative Visionaries & Academic Researchers

Regulatory Information & Commitment:
What Sets Us Apart

Under FDA’s regulations for human cells, tissues, and cellular and tissue‑based products (HCT/Ps), 21 CFR 1271.15(b) states: “You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.

 

On December 9, 2025, the U.S. Food and Drug Administration’s Tissue Reference Group (TRG) sent an informal recommendation in response to a legal inquiry about our bone marrow aspirate concentrate (BMAC) procedure. In that letter, FDA staff stated:

 

"FDA’s Tissue Reference Group concluded that, based on the procedure exactly as described in the submission, our bone marrow aspirate concentrate procedure “appears to qualify for the same surgical procedure exception described in 21 CFR 1271.15(b).” This exception is a narrow exemption in FDA’s HCT/P regulations for autologous procedures where tissue is removed and re‑implanted into the same patient during the same surgical operation and remains essentially in its original form."(fda.gov)

© Copyright C. Bertolotto MD and S. Heneidi MD. All rights reserved.
© Copyright 2010 Cristina Bertolotto, MD. All rights reserved.

Request a Consultation

Our team is dedicated to providing you with the highest level of care and attention, and we look forward to meeting your needs at a time that works best for you. Contact us to learn more about our educational programs and ongoing research initiatives. 

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Address

301 N. Canon Drive, Suite 305
Beverly Hills, CA 90210

Phone

424-490-BHCM (2426)

Email

301 N. Canon Drive

Suite 305

Beverly Hills, California 90210

310.490.BHCM (2426)

DISCLAIMER: The information provided on this website is for general educational purposes only and is not medical advice. Any references to cellular or regenerative approaches describe areas of ongoing scientific and clinical research. Except where specifically identified as an FDA‑approved product, the cellular procedures discussed on this website have not been evaluated or approved by the US Food and Drug Administration (FDA) to diagnose, treat, cure, or prevent any disease or condition. FDA has stated that stem cell products and products derived from adipose tissue of the type described here have not been approved to treat orthopedic, neurologic, cardiopulmonary, autoimmune, or other chronic conditions.(fda.gov)

Any cellular procedure carries potential risks, and benefits are uncertain. Decisions about care should be made in consultation with a licensed healthcare professional who can review all conventional and investigational options. BH Cellular Medicine endeavors to operate in compliance with applicable US laws and regulations governing human cells, tissues, and cellular and tissue‑based products (HCT/Ps), including requirements under section 361 of the Public Health Service Act and 21 CFR Part 1271, where applicable.(fda.gov)

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