US Stem Cell Inc (USRM)

[Xpecht]

Read a good article today! Link at bottom...

“the U.S. holds the most stringent regulations for SVF”

“Exemption from the drug pathway occurs when the harvesting of the adipose tissue is processed during the “same surgical procedure.”

“In Japan, “The Act on the Safety of Regenerative Medicine” which regulates medical professionals' practices and clinical studies related to regenerative medicine classifies SVF as a low risk or medium risk depending upon the level of risk associated with the medical treatment.”

“In Europe, MSCs are classified as advanced therapy medicine products (ATMPs) guided through the European Medicines Agency (EMA). According to Directive 2004/23/EC and 1394/2007, in procedures in which SVF is autologous, cell administration is conducted in the same surgical procedure, and the essential function of cells is considered to be the same as in the donor's fat tissue, the cellular therapy treatment is not considered an ATMP.”

“In Australia, legislative framework for the regulation of human cell and tissue products by the “Therapeutic Good Administration” (TGA) allows products that are derived from human tissue and cells during medical procedures that are considered a part of medical practice to be excluded from regulation provided they are collected from a patient who is under the clinical care and treatment of a licensed medical provider and manufactured by that medical provider for the therapeutic application in the treatment of a single indication and in a single course of treatment of that patient by the same medical provider, or by a person or persons under the professional supervision of the same medical provider. Thus, SVF is exempt from regulation in Australia based on the criteria discussed previously (https://www.tga.gov.au).”

“Conclusion...
Given its abundance and mixture of potentially therapeutic cells, the treatment of various diseases and conditions with SVF-derived cell therapies holds great clinical promise.”


https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.16-0337


Can’t wait for the good old US of A to get up to speed with other countries! Just a matter of time!