A new study takes a close look at the content and potential implications of the new Texas law HB 810, which aims to expand assess of experimental stem cell interventions outside the realm of clinical trials under FDA oversight. HB 810 represents a new level of deregulation after the Right To Try laws and presents concerns including ambiguity over what constitutes a chronic illness, reporting requirements, and safety concerns, as described in an article in Stem Cells and Development, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.
In the article entitled "Texas H.B. 810: Increased Access to Stem Cell Interventions or an Increase in Unproven Treatments?" coauthors Bhavana Kunisetty and Kirstin Matthews, PhD, Rice University, Houston, TX describe HB 810 as the first step toward an expansion of the Right to Try laws. Those laws, in response to the FDA's prolonged approval process, allow terminally ill to request access to experimental drugs without FDA approval. HB 810 gives access to investigational stem cell treatments to patients with certain severe chronic diseases or terminal illnesses.
"This important article reaffirms our continuing commitment as a journal to discuss issues germane to the responsible advancement of regenerative medicine," says Editor-in-Chief Graham C. Parker, PhD, The Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI.