Ethics of Cell and Gene Therapy (ECGT) Committee

Charter

The ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT) strives to:

1. Identify key ethical issues associated with the development, regulatory authorization, marketing, and distribution of cell and gene therapies.
2. Share knowledge and effective strategies among scientific and medical societies, health care providers and institutions, patient associations, and patients and their families.
3. Promote rigorous research, appropriate clinical investigation and application of, and equitable access to cell- and gene-based therapies.

Formerly known as the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies (PTF).

Selected Publications

• International Society for Cell & Gene Therapy Expanded Access Working Group position paper: key considerations to support equitable and ethical expanded access to investigational cell- and gene-based interventions (2025)
  
  
• An International Society for Cell & Gene Therapy working group short report on the future of expanded access to unapproved cell and gene therapies (2023)
  
  
• International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products (2023)
  
  
• The peril of the promise of speculative cell banking: Statement from the ISCT Committee on the Ethics of Cell and Gene Therapy (2022)
  
  
• Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products (2022)
  
  

Committee Chair

Bruce Levine PhD University of Pennsylvania School of Medicine United States

Committee Vice Chairs

Members

Alexey Bersenev
MD, PhD
Yale University
United States

Hamid Bidkhori
MD, PhD
Hudson Institute of Medical Research
Australia

Wilson W. Bryan
MD
Independent Regulatory Consultant
United States

Mikey Creane
PhD
HAON Life Science
Ireland

Massimo Dominici
MD
Founding Member
University Hospital of Modena, Reggio Emilia-Modena Policlinic
Italy

Patrick Foong
PhD
Western Sydney University
Australia

Massimiliano Gnecchi
MD, PhD, FESC
University of Pavia
Italy

Kat Kozyrytska
M.S.
AI Implementation & Commercialization
USA

Elena Maryamchik

MD
Memorial Sloan Kettering Cancer Center
United States

Jeanne Loring
PhD
Scripps Research
United States

Nicola Redfern
N J Redfern Ltd.
United Kingdom

Beth E. Roxland
JD, MBioethics
Roxland Consultants Ltd.
United States

Simona Stankeviciute
MD
Parexel International
Lithuania

Kunihiko Suzuki
MBA
MEDINET Co LTD.
Japan

Joseph (Yossi) Schwartz
MD, MPH
Foundation for the Accreditation of Cellular Therapy (FACT)
USA