ISCT Presidential Task Force on the Use of Unproven Cellular Therapies

Concerns about Unproven Cellular Therapies

Cellular therapies and regenerative medicine approaches have the potential for hopeful avenues for many patients and physicians towards disease cure and treatment. These therapies must undergo rigorous scientific investigation to assess their safely and efficacy, and must gain regulatory health care approval from the appropriate agency before becoming a standard-of-care.

Unfortunately, a growing number of clinics in the United States and around the world have been operating outside these requirements. Several cases of physicians administrating cellular therapies without the proper regulatory approval and/or scientific validation have been identified, putting patients at risk. 

To address this issue, ISCT has devised a group of influential academics, clinicians, regulatory experts and patient advocates to address the complicated, sensitive and contentious issues around medical tourism and unethical stem cell use. The group, termed The Presidential Task Force on the Use of Unapproved Cellular Therapies (PTF/UCT), has been highly active within ISCT, generating many publications, featured below, and speaking at events. 

To view the roster of PTF/UCT members Click Here

 

Resources for Health Care Professionals and Patients 
Published by the Presidential Task Force on the Use of Unproven Cellular Therapies

REFERENCE GUIDE ON UNPROVEN CELLULAR THERAPIES (2015)
Talking about Unproven Cell Interventions
Click Here to Read

Authored by 23 leaders in the field, this open document identifies key aspects of unproven cellular interventions to promote effective communication between health-care stakeholders, and to highlight the role of rigorous research prior to treatment. Click Here.

Abstract to Reference Guide
Positioning a Scientific Community on Unproven Cellular Therapies

English - Italiano - Español - Português - 简体中文 - 繁體中文

 

Medical Societies, Patient Education Initiatives, Public Debate and Marketing of Unproven Stem Cell Interventions

Cell Therapy Medical Tourism: Time for Action

Patient Advisory for Stem Cell Therapy and Medical Tourism 

Daniel Weiss
Leigh Turner
Aaron Levine
Laertis Ikonomou

Click to Read

Kurt Gunter
Arthur Caplan
Edwin Horwitz
et al.

Click to Read

Joint statement endorsed by 13 professional organizations 

Click to Read

 

Additional Resources

 

The Path to Successful Commercialization of Cell and Gene Therapies:
Empowering Patient Advocates - Click Here
ISCT Commercialization Committee Patient Advocacy Task Force

Information on Stem Cell Treatments - Click Here
Published in the Journal of the American Medical Association (JAMA)

ISCT Webinar: Lessons from Unregulated Clinics in Australia and Japan - Click Here
ISCT Australia & New Zealand Regional Committee

 

 News

 August 30, 2017 ISCT Response to Aug 28th FDA Statement Concerning Regulatory Oversight of Cellular Therapies
August 28, 2017 US FDA Commissioner Scott Gottlieb, M.D., issues statement on the FDA's new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
July 7, 2017

Global interest in report co-authored by members of ISCT Presidential Task Force on UCT

December 2, 2016

ISCT Publishes Article in Translational Scientist Concerning the US REGROW Act

October 19, 2016

ISCT Presidential Task Force Publishes Article in Brain Circulation Journal

  

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