Regulations of Mesenchymal STEM CELLS
and Their Allowed Use

At THE STEM CELL ORTHOPEDIC INSTITUTE OF TEXAS, ADULT STEM CELLS used are not more than minimally manipulated and are not cultured.  They are used for orthopedic problems and pain conditions.


  1. The differenation of low risk 361products is based on four criteria that help determine the risk for adverse events. The FDA tissue regulation 21 CFR part 1271 outlines the current guidelines for STEM CELL based therapies that may be used by clinicians. The criteria based on the principles are the following:
    • Minimal manipulation of STEM CELLS
    • Homologous use (Non-homologous use is where adipose MESENCYHMAL STEM CELLS (MSC’s) are used for an orthopedic indication).
    • Non-combination products.
    • Lack of systemic effect.
    • Use STEM CELLS within a short period of time.

    Any product that does not meet all five criteria are characteristed above as a 361 product and requires premarket approval

  2. The regulation 21 CFR 1271; – – If the STEM CELLS are more than minimally manipulated – – It is considered a drug.Fat STEM CELLS (adipose cells) when properly isolated, unlike bone marrow concentrates, are a drug as per the FDA. The rationale for why processed adipose tissue is a drug is that adipose requires digestion or breakdown of the collagen matrix of the tissue and thusly ALTERS the biologic characteristics of that tissue. However, for bone marrow, the tissue exists in a liquid suspension so that the cellular digestion of the collagen matrix IS NOT REQUIRED.
  3. Consequently to date, minimally manipulated BONE MARROW ASPIRATE and PRP fall under the heading that they are not manipulated. When bone marrow cells are manipulated, this is not FDA approved in the United States and their use is not allowed. So cells that have significant processing beyond a simple centrifugation are not allowed to be used in the United States.


FDA Guidlines



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