Informational Resources

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.

Published in the European Respiratory Journal

Published in Cytotherapy 

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.

Part I: “The Force Awakens”

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

Part II: “A New Hope”

• MSC-based Approaches
• Immuno-Gene Therapy Approaches

Hosted by ARM, ARMF, and ISCT

By Leigh Turner, PhD

Author

Resource

 FDA Warning Letters

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

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

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)

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.

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.”

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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.