ISCT Statement of Concern Regarding Speculative Commercial Cell Banking Services
The International Society for Cell & Gene Therapy (ISCT), in conjunction with the undersigned partner professional and educational societies in the field of Cell and Gene Therapy, express a strong concern with the recent growth of speculative cell banking services that prey upon people’s fears while offering little, if any, prospect of medical benefit. Commercial cell banking services – including the banking of T-cells, dental cells and cells for the derivation of induced pluripotent stem cells for potential therapeutic uses, for example, are not supported by current scientific evidence. Without a clearer pathway to legitimate clinical use, offering these services commercially to patients is premature, misleading, and drives false hope.
The ethical principle of respect for persons, embodied by the process of informed consent, calls for individuals to be respected as autonomous beings and empowered to make their own informed decisions about their medical care. However, despite the potential of cell therapy, the firms offering these cell banking services cannot claim to know if the cells they preserve today could ever be appropriate for clinical use in future. The “tokens of scientific legitimacy”, utilized by these firms include the use of scientific advisory boards (with members who may or may not fully endorse the specific products), links to journal articles, reference to ongoing clinical trials. These suggest a stronger scientific basis than currently exists. Further, these firms cannot say whether banked cells would be acceptable for use by commercial cell therapy manufacturers or meet the requirements of national and international regulatory agencies.
As strong supporters of scientifically validated cell and gene therapies, we welcome innovations, including cell banking approaches, that promise to increase the number of patients who can benefit from these transformative therapies. We remain concerned, however, that the marketing of speculative cell banking services in the absence of appropriate pre-clinical, and clinical evidence and without plausible pathway to clinical use for banked cells is misleading and potentially detrimental to the future development of cell and gene therapies.
Consortia of Endorsing Organizations (alphabetical):
- American Society of Gene & Cell Therapy (ASGCT)
- American Society for Transplantation and Cellular Therapy (ASTCT)
- European Society for Blood and Marrow Transplantation (EBMT)
- Forum for Innovative Regenerative Medicine (FIRM)
- Foundation for the Accreditation of Cellular Therapy (FACT)
- International Society for Stem Cell Research (ISSCR)
- Joint Accreditation Committee ISCT-EBMT (JACIE)
- Society for Immunotherapy of Cancer (SITC)
Want to add your organization to the consortia? Please contact firstname.lastname@example.org.