ISCT Publishes Comprehensive Guide to Safeguard Patients Against Unproven Cell and Gene Therapies

By Lauren Reville posted Oct 05, 2023 12:59


The guide aims to educate ISCT members, healthcare professionals, and the public about the risks related to the direct-to-consumer regenerative therapy industry, exposing common deceptive marketing tactics and highlighting channels to report these practices.

VANCOUVER, British Columbia October 5, 2023, The International Society for Cell & Gene Therapy (ISCT), the translational-focused global community of cell and gene experts today announces the publication of a guide designed to educate and protect patients against unproven cell and gene therapies titled, ‘International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products.’

The paper developed by the ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT) serves as a resource to educate patients on identifying false or misleading claims about unproven cell- and gene-based interventions and provides an overview of reporting mechanisms for potentially harmful products and unethical practitioners and treatment providers. The paper also explores further actions for the sector to correct misrepresentations about cell and gene therapies in the media and suggests practical strategies to address the direct-to-consumer marketing of unproven products.

ISCT strongly opposes the premature commercialization of unproven cell and gene-based interventions. Through its work with the ECGT committee, ISCT aims to educate the sector and the wider patient community on the potential dangers of such interventions and emphasizes the need for evidence-based therapies/products that have been rigorously tested in clinical trials.

Highlighting the importance of ethics to ensure patient safety, Laertis Ikonomou, PhD, Immediate Past Chair of the ISCT ECGT Committee and First Author, stated “The position paper was developed to further ISCT’s mission to combat the prevalence of unapproved and harmful treatments and ultimately protect patients. The research uses science-based evidence to raise awareness of the risks associated with unproven interventions and highlights the level of evidence and safety required for scientifically and clinically validated therapies that the public may not be aware of. We hope that our research will enable patients to make informed decisions regarding therapies and empower those who believe they have been harmed by the administration of unapproved products to report such vendors.”

Speaking on the significance of the issue, Jacques Galipeau, MD, ISCT President said “The explosive growth of the cell and gene therapy sector coupled with the surge in demand for new treatments has unfortunately led to the rise in the availability of direct-to-consumer unproven cell and gene-based products which have not undergone the proper approval and testing. These products, lacking proper approval and testing, pose a great risk to patients and are often promoted with misleading claims about their safety and efficacy. ISCT strongly opposes commercialization of such products, and this guide reaffirms our continued support for the need for the ethical and meticulous development of cell and gene-based products, where patient safety and therapeutic benefits are the guiding principles.”

Read the full paper here.

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 cell and gene therapy into safe and effective treatments to improve 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 critical areas of translation: Academia, Regulatory, and Commercialization. Through solid relationships with global regulatory agencies, academic institutions, and industry partners, ISCT drives the advancement of research into a standard of care.

Comprising over 3,000 cell and gene therapy experts across five geographic regions and with 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, @ISCTglobal.

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