US state laws on medical freedom and investigational stem cell procedures: a call to focus on state-based legislation
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Cytotherapy. 2024 Feb 3:S1465-3249(24)00020-3. doi: 10.1016/j.jcyt.2024.01.002. Epub ahead of print. PMID: 38310500.

US state laws on medical freedom and investigational stem cell procedures: a call to focus on state-based legislation

Authors: Kirstin R W Matthews 1Samantha J Lowe 2Zubin Master 3

Affiliation:

  1. Baker Institute Center for Health and Biosciences, Rice University, Houston, Texas, USA. Electronic address: krwm@rice.edu.
  2. Baker Institute Center for Health and Biosciences, Rice University, Houston, Texas, USA.
  3. Baker Institute Center for Health and Biosciences, Rice University, Houston, Texas, USA; Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA. Electronic address: zubin@zubsplace.com.

Abstract:

The premature marketing of investigational stem cell interventions (SCIs) is a growing market in the US. Several US states have passed legislation to permit and promote unproven and experimental SCIs for individuals with terminal or chronic diseases. These SCI medical freedom laws, which are largely based on right-to-try legislation, increase access to experimental SCIs with little to no oversight. They undermine federal regulatory authority and can compromise patient safety and informed decision-making. SCI medical freedom laws have gone largely unnoticed by scientific societies interested in the responsible translation of stem cell medicine. In this article, we analyze state SCI medical freedom laws and describe their detrimental impact on patients and society. We contend that scientific and medical societies are uniquely poised to advocate against state-based policy promoting unproven SCIs but recognize resource and other constraints to advocate for or against legislation in 50 states. We recommend societies establish coalitions and share resources to address state-based SCI medical freedom laws and other legislation surrounding unproven SCIs.

Keywords: cell therapy; compassionate use; medical freedom; regenerative medicine; right-to-try; state policy

Download: https://www.sciencedirect.com/science/article/pii/S1465324924000203