Informational Resources

COVID-19 RESEARCH SPOTLIGHT

Cell-based treatments for COVID-19
By Laertis Ikonomou, PhD

The COVID-19 pandemic has produced a rush of candidate treatments, currently evaluated worldwide for safety and efficacy. We discuss issues related to the development of cell-based interventions for COVID-19.

Current Status of Cell-Based Therapies for Respiratory Virus Infections: Applicability to COVID-19
Maroun Khoury, Jimena Cuenca, Fernanda F. Cruz, Fernando E. Figueroa, Patricia R. M. Rocco, Daniel J. Weiss

Published in the European Respiratory Journal

Cell-Based Therapies for COVID-19: Proper Clinical Investigations are Essential
Maroun Khoury, Patricia R.M. Rocco, Mauro Krampera, Ivan Martin, Sowmya Viswanathan, Donald G Phinney, Jan A. Nolta, Katarina LeBlanc, Jacques Galipeau and Daniel J. Weiss

Published in Cytotherapy 

ISCT takes a stand against organizations marketing unproven COVID-19 cell and gene therapies
Wednesday, March 25, 2020

Following up on a statement made on March 20th, ISCT has issued a press release taking a stand against organizations marketing unproven COVID-19 cell and gene therapies.

LIVE at ISCT 2020 Paris Virtual – ISCT CSO Global Showcase on COVID-19 

Part I: “The Force Awakens”

  • Review of Current Understanding of COVID-19 Pathogenesis
  • Reports from the Front Lines
  • Supply Chain Issues

LIVE at ISCT 2020 Paris Virtual – ISCT CSO Global Showcase on COVID-19 

Part II: “A New Hope”

  • MSC-based Approaches
  • Immuno-Gene Therapy Approaches

ISCT Presidential Task Force Members Laertis Ikonomou, Daniel J. Weiss, and Megan Munsie interviewed by The Medical Republic regarding concerns about the marketing of unproven therapies during the pandemic. 

ISCT CSO Daniel J. Weiss moderates Webinar on Potential COVID-19 Treatments Using Cell Therapies

Hosted by ARM, ARMF, and ISCT

Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed “Stem Cell Treatments” for COVID-19

By Leigh Turner, PhD

LISTINGS OF APPROVED PRODUCTS & OTHER USEFUL RESOURCES

Cell, Tissue and gene products with marketing authorization in 2023 worldwide

Author

Resource

Food and Drug Administration

 FDA Warning Letters

General Assembly of the State of Vermont

Legislature relating to health care practitioners administering stem cell products not approved by the U.S. Food and Drug Administration

ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies

Annual Report – Cell, Tissue and Gene Products with Marketing Authorization in 2018 worldwide

List of cell/tissue/gene products with marketing authorization – updated November 2022

ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies

Positioning a Scientific Community on Unproven Cellular Therapies (Multiple Languages)

English – Italiano – Español – Português – 简体中文 (Simplified Chinese) – 繁體中文 (Traditional Chinese) – 한글 (Korean) – Français – Deutsch  – हिंदी  (Hindi) – فارسی (Farsi)

ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies Reference Guide – Talking About Unproven Cell-Based Interventions
ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies Medical Societies, Patient Education Initiatives, Public Debate and Marketing of Unproven Stem Cell Interventions
The Journal of the American Medical Association (JAMA) Identifying the Risks of Unproven Regenerative Medicine Therapies

Marks PW, Hahn S. Identifying the Risks of Unproven Regenerative Medicine Therapies. JAMA. Published online June 17, 2020. doi:10.1001/jama.2020.9375. Copyright © (2020) American Medical Association.  All rights reserved.

Wondery Bad Batch Podcast**

Patients in search of a miracle cure end up in critical condition. The race is on to find out what went wrong before more people get hurt. The trail leads back to a medical company with slick marketing and a charismatic CEO. And to a multibillion dollar stem cell industry where greed and desperation collide. Laura Beil, the award-winning host and reporter of “Dr Death,” returns for this six-part investigative series from Wondery, the makers of “Dirty John” and “The Shrink Next Door.”

**These links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by ISCT of any of the products, services or opinions of the corporation or organization or individual. ISCT bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

The Journal of the American Medical Association (JAMA) Information Fact Sheet
Joint Statement from Prominent Professional Organizations Patient Advisory for Stem Cell Therapy and Medical Tourism
ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies Cell Therapy Medical Tourism: Time for Action
ISCT Immuno-Gene Therapy Committee ISCT Webinar – Gene Therapy and Gene Editing for Hemoglobinopathies

The ongoing progression of gene therapies towards clinical use has led to an increased number of clinical trials in recent years and global discourse around the therapeutic potential, ethical considerations and future application of gene therapy and gene editing. As a result, there is an increased need for patient resources that provide information and insight into these novel therapies.

Developed by the ISCT Immuno-Gene Therapy Committee as a resource for patient advocacy groups, patients and their families, this webinar will define gene therapy and outline the mechanism of action and current status of gene therapies for hemoglobinopathies, such as sickle cell disease and thalassemia. To close the session the future of gene therapy and gene editing will be discussed, and key considerations identified that can help ensure the safe and effective utilization and overall advancement of such therapeutic products.

ISCT Commercialization Committee Patient Advocacy Task Force Empowering Patient Advocates
ISCT Australia & New Zealand Regional Committee ISCT Webinar – Unregulated Clinics in Australia and Japan