3guidelines—if the Texas Medical Board thinks it necessary to develop guidelines intended tosupplement federal regulations— must include a far more detailed account of what types of interventions involving different kinds of stem cells require submission of IND applications to theFDA.
2) Most (though not all) interventions involving administration of stem cells require submittingan Investigational New Drug Application to the FDA
having study protocols approved byInstitutional Review Boards
Comments made by several members of the Adult Stem Cell Research/Treatments Stakeholder Workgroup as well as correspondence sent by various individuals to the Texas Medical Board suggestthat one major reason for classifying “stem cells” as investigational agents is to permit physicians toadminister to patients adult autologous stem cells without first having to submit to the FDAInvestigational New Drug applications. As members of the Texas Medical Board presumably know, 21Code of Federal Regulations 1271 (See Appendix) makes important distinctions concerning howdifferent stem cells, tissues, and cellular and tissue-based products (and methods of processing them)are regulated.Some procedures involving administration of stem cells do not require submission of an INDapplication to the FDA. For example, physicians are not required to submit IND applications to FDA if they perform procedures in which stem cells are minimally manipulated, are intended for homologoususe, are removed from an individual and implanted into the same person during the same surgical procedure, and meet additional standards listed in 21 CFR 271. However, according to 21 CFR 1271,“If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in1271.10(a), and you do not qualify for any of the exceptions in 1271.15, your HCT/P will be regulatedas a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, andapplicable regulations in title 21, chapter I.” What this standard means is that use of many differenttypes of stem cells requires
submission of an Investigational New Drug application to the FDA
approval of research protocols by Institutional Review Boards.According to 198.3 (b), “Prior to administering or providing of investigational agents, physicians musthave their proposed use either included in an FDA/NIH approved protocol/study or approved by anIRB.” This language is misleading. If researchers wish to administer an Investigational New Drug inthe context of a clinical trial, there are two major regulatory pathways that must be navigated.Researchers are not free to select whichever option they prefer. First, researchers must submit to theFDA an Investigational New Drug (IND) application. The FDA then has 30 days to decide whether or not to put a hold on the application. Second, research involving investigational agents must bereviewed, evaluated, and approved by an Institutional Review Board. By not being precise about theextent to which “investigational agents” are similar to or different from what the FDA describes as“Investigational New Drugs” and by asserting that researchers can submit to the FDA/NIH
an IRB, itappears that Chapter 198, if approved, would dramatically reduce protections for research participants.It is possible that the proposed guidelines are not intended to subvert federal regulations specifying thatresearchers planning to conduct clinical studies involving Investigational New Drugs must first submitIND applications to FDA. If the guidelines are meant to support this longstanding protection for research projects and are not intended to pose a challenge to federal regulations governing medical