There is (was) a doc in Eugene OR doing stem cell injections (along with plenty of totally wacky things) who lost his license. The OMB listed "stem cell injections outside of a clinical trial" as one of the reasons for discipline.
I went to Rosenthal's course. Great as usual. Definitely a commercial bias. When I raised the question of problems with one's local medical board it seemed that it hadn't been considered in depth. I wrote to the OMB and got a very negative and ambiguous response. I checked the FDA's website and found contradictions and so wrote to them and their response raised more questions and provided little in the way of answers. The FDA response is copied below.
Thank you for writing to the Center for Biologics Evaluation and Research (CBER). One of seven centers within the FDA, is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic extracts, tissue, and cell and gene therapy products. We hope that the information which we are able to provide will be helpful.
Human cells and tissues intended for use in humans are regulated by CBER as human cells, tissues and cellular and tissue-based products (HCT/Ps). FDA has a risk based approach to the regulation of HCTP/s. Under the authority of Section 361 of the Public Health Service (PHS) Act, FDA established regulations for all HCT/Ps to prevent the transmission of communicable disease. These can be found in Title 21 of the Code of Federal Regulations (
21 CFR Part 1271).
The regulations in 21 CFR Part 1271 identify the criteria for regulation solely under Section 361. HCT/Ps that meet all of the criteria in 21 CFR Section 1271.10(a) are regulated solely under Section 361 of the PHS Act. If all of the criteria in 21 CFR Section 1271.10 are met then no pre-market review (application to FDA) is required. To satisfy these criteria, an HCT/P must be: minimally manipulated (relates to the nature and degree of processing); intended for homologous use only (the product performs the same basic function in the donor as in the recipient); not combined with another article (with some limited exceptions); and the HCT/P does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function, or if it does, the HCT/P is intended for autologous use or use by a first- or second-degree blood relative.
HCT/P establishments must register with the FDA and submit a list of every HCT/P manufactured within 5 days after beginning operations (see 21 CFR 1271.21). Registration of an HCT/P establishment with FDA does not in any way denote approval of the firm or its products. Registered establishments undergo routine inspections to determine compliance with the applicable regulations. You can query the list of registered establishments in the Human Cell and Tissue Establishment Registration (HCTERS) database on CBER's website at
http://www.fda.gov/cber/tissue/tissregdata.htm. You can also find the dates of inspection and the inspection classification in our publicly available database (see
http://www.fda.gov/ICECI/Inspections/ucm222557.htm).
HCT/Ps that do not meet all of the criteria of 21 CFR Section 1271.10 are also regulated under Section 351 of the PHS Act and/or the Federal Food, Drug and Cosmetic Act as drugs, devices and/or biological products and require premarket approval prior to distribution.
The FDA issued a number of untitled letters to manufacturers of amniotic-membrane based products whose products did not meet the minimal manipulation and/or the homologous use criteria (see
untitled letters). As a result, these HCT/Ps are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act and biological products as defined in section 351(i) of the PHS Act. Thus premarket approval is required, but no such products have been approved.
FDA has also issued four
draft guidances related to the regulation of HCT/Ps as listed below. The guidances on minimal manipulation and homologous use may be of most interest.
• Same Surgical Procedure Exception under § 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry (Same Surgical Procedure Exception Draft Guidance) (October 2014);
• Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff (Minimal Manipulation Draft Guidance) (December 2014); and
• Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry (Adipose Tissue Draft Guidance) (December 2014).
• Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff (Homologous Use Draft Guidance) (October 2015)
The comment period for all four draft guidances is currently open to allow interested stakeholders to provide critical input across the full scope of the FDA’s thinking in these areas. Once the comment period ends, the FDA will carefully review and consider all comments received on the draft guidance documents and make modifications and additional clarifications as necessary. When finalized, the guidance documents will represent the FDA’s current thinking on how certain regulations apply to various HCT/Ps. The agency will also hold a
public hearing on April 13, 2016 to obtain additional public input.
We hope this information has been helpful.
Sincerely,
