ISCT stands against organisations marketing unproven COVID-19 CGTs

Patients urged to seek official medical advice to prevent surge in unethical treatments outside clinical pathways

Vancouver, Canada, March 25, 2020 - The International Society for Cell & Gene Therapy (ISCT), the global society of clinicians, researchers, regulators, technologists, and industry partners dedicated to the translation of cellular therapy into safe and effective therapies to improve patients’ lives, today announces it is discussing with scientific and industry organizations and regulators a range of actions against the proliferation of unproven and untested ‘stem cell’–based therapies with claims to treat COVID-19. It also urges patients and families to consult expert medical professionals for the most accurate available information on treatment options. 

“Organizations across the life science industry, including the cell and gene therapy (CGT) sector, are currently united in the key focus of finding evidence-based treatments and vaccines for the current COVID-19 pandemic. These therapies and vaccines could save vast numbers of lives globally,” said Dr Daniel Weiss, MD, PhD, Chief Scientific Officer of ISCT. “It is critical that these vital and urgent efforts are not hampered by unscrupulous companies profiting by offering false and unproven interventions. These false interventions can cause immense harm by eroding the confidence of the public, investors, and the wider communities in the medical and biopharma sectors at the very time it is needed most.” 

ISCT set up its Presidential Task Force in 2014 in its ongoing commitment to address the rise of commercially available unproven cell and gene therapy treatments. In October 2019, it formed a cell and gene therapy sector-wide coalition of organizations across the globe to combat the rise in the number of unproven commercial cell banking services. The PTF also publishes a biennial report detailing global CGT with market authorization which patients and physicians can utilize to make informed decisions on treatments. ISCT is currently in conversations with its consortia partners, as well as regulators and governments globally, regarding options to prevent organizations operating outside of current clinical guidance.

Prior to the current COVID-19 pandemic, ISCT identified that the unproven cell therapy market is currently worth up to USD 2.4 billion and involves approximately 60,000 patients annually, paying up to USD 40,000 per treatment. ISCT believes that during the current COVID-19 climate, the number of patients and the costs of these ‘treatments’ will considerably increase. 

“The current climate of a quickly spreading COVID-19 infection and a lack of approved treatments creates a perfect storm that results in a plethora of unethical organizations offering unproven therapies. These organizations offering untested therapies outside of proper clinical pathways for COVID-19 create a real and immediate risk to life. These treatments often lack proof of efficacy, and potentially have a very high cost to desperate patients. Most importantly, these ‘treatments’ produced with no evidence can be even more dangerous to the immediate health of patients and their communities,” said Dr. Laertis Ikonomou, PhD, co-chair of the ISCT PTF on the Use of Unproven and/or Unethical Cell and Gene Therapy. “ISCT will work with government agencies and regulatory bodies internationally to take action against those looking to profit from a pandemic that is affecting so many people across the globe.”

About the International Society for Cell & Gene Therapy

Established in 1992, the International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists and industry partners with a shared vision to translate cellular and gene therapy into safe and effective therapies to improve patients’ lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory and Commercialization. Through strong relationships with global regulatory agencies, academic institutions and industry partners, ISCT drives the advancement of research into standard of care.
Comprised of over 1700 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders and organizations invested in cell and gene therapy translation. For more information about the society, key initiatives and upcoming meetings, please visit: www.isctglobal.org, @ISCTglobal.