Sign this petition to urge the Texas Medical Board and the United States Food and Drug Administration (FDA) to affirm a patient’s right to use one's own adult stem cells.
The FDA recently released a memo suggesting patients need to be cautious and insure that adult stem cell therapies be approved by the FDA or considered investigational (experimental), and therefore subject to the FDA regulatory process.
If subjected to onerous regulation you would be restricted from using your adult stem cells obtained from your own body, specifically from bone marrow or fat tissue, in a manner that you and your physician believe is appropriate.
MedRebels believes that adult stem cells that are obtained from a patient’s own body, in full compliance with existing FDA regulations and guidelines, should NOT be classified as a drug as long as they meet the following criteria: (1) The cells are from the patient’s own body (NOT from a donor); (2) The cells are obtained and used in the same medical procedure (NOT grown outside the body, frozen or stored); (3) The cells are subjected only to minimal manipulation (NOT disrupted or extensively processed)
Sign this petition to request the FDA to classify non-cultured, minimally manipulated autologous cells under 21 CFR part 1271, Section 361, and NOT as investigational products or drugs under Section 351.
We are a nonprofit organization whose mission is to enhance the quality of life through preventative and regenerative adult stem cell research and education.
The views expressed in this petition are solely those of the petition's sponsor and do not in any way reflect the views of iPetitions. iPetitions is solely a provider of technical services to the petition sponsor and cannot be held liable for any damages or injury or other harm arising from this petition. In the event no adequate sponsor is named, iPetitions will consider the individual account holder with which the petition was created as the lawful sponsor.