Abstract

Adipose Derived Stromal Vascular Fraction and the FDA: The Cell Surgical Network Position

Mark Berman, Past President/Medical Director, California Stem Cell Treatment Center

Objective
Over the last two years the Cell Surgical Network (CSN) has fielded several criticisms from a number of scientists and bio-ethicists questioning their right to deploy adipose derived SVF.  Code of Federal Regulation 21 part 1271 provides a list of elements that allow the FDA to determine whether Human Cells, Tissues and Tissue Products are a drug that can be regulated by the FDA.  Letters from FDA Tissue Reference Groups have been circulated as proof that groups such as CSN are in violation of these FDA regulations.  This presentation will argue that CSN is indeed in full compliance of the FDA regulations.  Further it will address the controversy and point out how these misrepresentations have gained so much traction with many groups of doctors, scientists and ethicists.  

Methods
A thorough review of CFR 21 part 1271 and a complete understanding of the procedure performed by CSN will help verify our findings of compliance and ethical behavior.

Results
A thorough understanding of the purpose of the FDA rules and regulations along with an understanding of surgical practices along with validation of sterility will be essential for understanding CSN compliance.  Further, it will be argued that the FDA does not have jurisdiction over a solution that can not be classified as a drug due to its actual lack of definable characteristics.  

Conclusion
CSN is in full compliance with FDA CFR 21 part 1271 and maintains its ethical position in the practice of surgery.

CSCTC – California Stem Cell Treatment Center -  Rancho Mirage and Beverly Hills, CA
WA – World Anti-Aging Optimum Health Center – Shanghai, Beijing, China