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Papers highlight necessity of clinical investigations despite therapeutic demand around pandemic

Vancouver, Canada, May 11, 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 global efforts to lead the cell and gene therapy sector’s response to COVID-19. This has resulted in the acceptance for publication of three papers addressing the importance of proper clinical investigations to the development of COVID-19 therapies. These papers, authored by ISCT leaders, were submitted, under peer review, to the journals Cytotherapy and European Respiratory Journal.

The first paper published in Cytotherapy is entitled ‘Cell-Based Therapies for COVID-19: Proper Clinical Investigations are Essential (Journal Pre-Proof)’. This publication was spearheaded by Maroun Khoury and Daniel Weiss, leaders in the ISCT community, and their peers in the field. It specifically details that mesenchymal stromal cells (MSCs), MSC-derived conditioned media (CM) or extracellular vesicles (EVs) are the most common cell-based trials that have been initiated for COVID19. The global leaders in the scientific and clinical investigations of these cell types for a variety of indications, including acute respiratory distress syndrome (ARDS), are ISCT members, and working within guidelines provided by ISCT’s Presidential Task Force on the Use of Unproven and/or Unethical Cellular Therapies (PTF). The paper highlights the need for controlled trials, with detailed and rigorous follow up and analysis. These measures ensure trials provide an adequate measure of therapeutic efficacy, and do not detract from meaningful efforts to find effective treatments for COVID-19 when validated information is crucial.

The second ISCT paper published in Cytotherapy is entitled ‘Emerging Trends in COVID-19 Treatment: Learning from Inflammatory Conditions Associated with Cellular Therapies’. Led by Maria Cancio and sponsored by the ISCT Immuno-Gene Therapy Committee, this paper explores possible applications of the extensive knowledge of immune system modulation developed by the field of Cell and Gene Therapy in confronting hyper-immune responses to COVID-19. The paper highlights the potential of biological therapies in combination with supportive care and pharmacotherapies to overcome therapeutic challenges in treating COVID-19.

The paper published in the European Respiratory Journal is entitled 'Current Status of Cell-Based Therapies for Respiratory Virus Infections: Applicability to COVID-19', authored by Khoury et al. It details that although mesenchymal stromal cells (MSCs) have demonstrated safety and potential efficacy in Acute Respiratory Distress Syndrome (ARDS), these potential therapies have yet to be well studied in respiratory virus associated ARDS such as COVID19. It highlights the vital need for relevant pre-clinical data and postulated mechanisms of MSC actions in respiratory virus-induced lung injuries, and for this data to be the platform for potential clinical investigations. It also highlights that valid data justifies the therapeutic application, and the risk/benefit analysis is favorable for clinical entry.

To address the COVID-19 pandemic, ISCT has also added two flagship live sessions at the start and finish of its now virtual 2020 Annual Meeting, May 28-29, 2020. These sessions will detail the responsibility and contribution the cell and gene therapy sector needs to make to provide therapies for the pandemic, as well as the wider role of the sector during the pandemic. The sessions will be led by Daniel J. Weiss, Chief Scientific Officer, ISCT.

ISCT has already announced on March 25, 2020 that it is working with scientific and industry organizations and regulators on 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.

“There is an urgent need to develop tests, vaccines, and therapies for the current COVID-19 pandemic. However, urgency cannot result in shortcuts. Investigations of cell-based therapy for COVID19 and its complications need to be solidly evidence-based, well-designed, and conducted in an appropriate and transparent manner in order to yield valid and useful information,” said Daniel Weiss, CSO, ISCT. “The PTF is working with organisations and regulators internationally to ensure action is taken against those marketing unproven cell and gene COVID-19 therapies. Meanwhile, ISCT leaders and members have reinforced the need for proper clinical investigations into COVID-19 therapies that adhere to regulatory pathways. Lessening of this rigor in the face of an unprecedented need could result in even more serious future repercussions.”

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.

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