Adverse events related to unapproved stem cell products and other regenerative interventions: recommendations for more robust regulation of the direct-to-consumer marketplace-Reference-Cited by-同舟云学术

Adverse events related to unapproved stem cell products and other regenerative interventions: recommendations for more robust regulation of the direct-to-consumer marketplace

Published:2022-02 Issue:2 Volume:17 Page:63-68
ISSN:1746-0751
Container-title:Regenerative Medicine
language:en
Short-container-title:Regenerative Medicine

Author:

Akkas Farzana¹,Turner Leigh²^ORCID,Richardson Elizabeth³

Affiliation:

1. Senior Research Associate, Health Care Products Project, The Pew Charitable Trusts, 901 E Street NW, Washington, DC 20004, USA

2. Professor, Department of Health, Society & Behavior; Program in Public Health, Member, Stem Cell Research Center, University of California, Irvine, Anteater Instruction & Research Offices, 2nd Floor, 653 E. Peltason Dr., Irvine, CA 92697-3957, USA

3. Director, Health Care Products Project, The Pew Charitable Trusts, 901 E Street NW, Washington, DC 20004, USA

Abstract

Tweetable abstract Adverse events continue to occur in the direct-to-consumer market for unapproved regenerative interventions and the US FDA alone cannot adequately address the problem. Other public health strategies are needed to provide better patient protection.

Publisher

Future Medicine Ltd

Subject

Embryology,Biomedical Engineering

Link

https://www.futuremedicine.com/doi/pdf/10.2217/rme-2021-0124

Reference25 articles.

1. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions

2. The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis

3. Global Distribution of Businesses Marketing Stem Cell-Based Interventions

4. Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

5. The Pew Charitable Trusts. Harms linked to unapproved stem cell interventions highlight need for greater FDA enforcement (2021). http://www.pewtrusts.org/-/media/assets/2021/05/harms-linked-to-unapproved-stem-cell-interventions-highlight-need-for-greater-fda-enforcement.pdf

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