NEWS

The International Society for Cell & Gene Therapy (ISCT) has released the Japanese translation of its guideline titled “Unproven Cell and Gene Therapies: A Guide and Resources for Healthcare Providers.”

This guide provides information for healthcare practitioners on how to identify and distinguish safe and approved CGT products from those products that do not have a proven record of safety and efficacy, nor have received approval from appropriate regulatory organizations. This guide also provides information on how to report concerns, or actual harm that has resulted from the use of unproven products.

The Japanese version of the guideline is available at the following link:
https://www.isctglobal.org/education/ecgt-healthcare-provider-guide/jp?_zs=SHotN1&_zl=oVHL3

Comments
Bruce Levine (Chair, ISCT Committee on the Ethics of Cell & Gene Therapy)
“If we are to combat the growing number of business providing unregulated CGTs, it is essential to equip physicians, caregivers, and patients with reliable and impartial information. This guide empowers healthcare providers to protect their patients from harmful, unregulated treatments and it is instrumental in ensuring the growth of our sector continues to meet research and clinical standards.”

Koji Nishida (President, Japanese Society for Regenerative Medicine)
“JSRM recognizes that this guideline is crucial for the advancement of regenerative medicine and expresses its full support. As stated in the “Yokohama Declaration 2025” announced in March 2025, we advocate for the establishment of “Explorative Therapy” as an ethical and scientifically grounded framework, which addresses not only regulated treatments but also the responsible governance of interventions accessible under Japan’s Act on the Safety of Regenerative Medicine (ASRM), including therapies yet to receive formal approval. We are actively working toward developing and implementing robust mechanisms to support this approach. Furthermore, JSRM remains committed to strengthening our collaboration with international organizations such as ISCT, fostering cooperative relationships to ensure global alignment in standards and ethical practices.”

For more information, please contact:
INTERNATIONAL SOCIETY FOR CELL & GENE THERAPY (ISCT)
E-mail: isct@isctglobal.org