By Ana S. Iltis, Grace Koster, Emily Reeves & Kirstin R. W. Matthews

Abstract

Recent advances in methods to culture…

Abstract

Scholars began reporting about this marketplace in the mid-2000s; however, there is no sign of it dissipating…

Scientists and members of the public exploring the controversial area of U.S. human embryo and embryoid research will find a complex and sometimes bewildering assortment of federal and state laws. The authors recommend additional guidance, but note slow progress in the development of embryo research policy.

Companies developing stem cell-based interventions should work with policymakers and patient advocates to address risks for current and future patients and to protect clinical research and the reputation of the field, write the authors. Read their full article in Cell & Gene Therapy Insights (free registration).

The intense marketing of unproven stem cell interventions has become an international health concern. The authors offer resources and suggestions for physicians seeking to effectively counsel patients and respond to their questions about various stem cell therapies.

The unproven stem cell intervention industry is a worldwide, direct-to-consumer market where clinics offer stem cells or stem cell-derived components to patients with little to no scientific or clinical basis. In this paper, the authors call for the establishment of a World Health Organization Expert Advisory Committee on Regenerative Medicine to tackle this issue and provide guidance. Stem Cell Reports: https://doi.org/10.1016/j.stemcr.2021.05.004

The connection between Texas H.B. 810, which allows clinics to provide investigational stem cell treatments to certain patients, and a deregulation movement to increase patient access to unproven stem cell treatments is described in this report.

A growing number of stem cell clinics treat a variety of illnesses and injuries, yet few have conducted the necessary clinical research to ensure safety and efficacy. The authors highlight the importance of collaboration between scientists, regulators, patients and patient advocates in developing effective policies and practices for unproven stem cell-based intervention clinics.

This journal article examines the risks patients face in seeking experimental stem cell-based interventions from clinics outside the United States. The authors advocate for new public policies that encourage patients to remain in clinical trials in the U.S.

While the Food and Drug Administration currently regulates storage and use of cord blood (CB) in the United States, other state and federal guidelines on CB education, awareness and ethical considerations remain variable, and no mandatory international guidelines exist. To help organize and coordinate efforts across the United States and other nations, policymakers should implement regulations for high quality standards for both private and public CB banks.