A portfolio of international and digital meetings designed for knowledge sharing and collaboration to further the field. Read more about upcoming programs, including the 2024 ISSCR Annual Meeting.

The ISSCR sets international guidance for ethical and rigorous research, adopted by public and private organizations, regulatory bodies, funds, and publications. These references strengthen the pipeline of research and therapies, ultimately to benefit the patient.

Recently launched, AboutStemCells.org, is a public education website to educate and engaging the public in stem cell science. Current content covers basics of stem cell biology, introduces the translation of science into medicine, and includes important resources for patients and families considering stem cell treatments, including an updated ISSCR Patient Guide, downloaded more than 1,500 times.

ISSCR committees continue to increase work in regulatory affairs. In November 2023, the society responded to its first FDA Draft Guidance on manufacturing and comparability, and intends to respond to a newly issued Draft Guidance on potency assays.

ISSCR continues to meet with regulatory agencies directly. In addition to its annual FDA Liaison Meeting, the ISSCR held its first meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency in 2023 and will hold its first meeting with the E.U.’s European Medicines Agency in early 2024. ISSCR is also exploring meeting with Japan’s Pharmaceuticals and Medical Devices Agency in late 2024.

Past meetings with regulatory agencies have focused on issues related to manufacturing (e.g., questions around manufacturing GMP and genomic instability). Future meetings will address new issues such as clinical trial design.

In addition to these efforts, the ISSCR is participating in a Foundation for the NIH-led effort to create a “Cell-based Therapy Consortium” under the Accelerated Medicines Partnership Program. This consortium will bring together the NIH, the FDA, academic researchers, representatives from pharmaceutical and biotech companies, and professional societies like ISSCR to identify challenges and propose solutions to developing cell-based therapies

ISSCR continues to monitor issues related to the ISSCR Guidelines. In June 2023, ISSCR members helped craft the ISSCR statement and talking points regarding embryo models. Later in the year, working group was initiated to produce a white paper on the current state of the research and address emerging questions. This paper will assist efforts to define and regulate embryo model research in jurisdictions like the U.K., the Netherlands, and Japan.

Additionally, the ISSCR continues to defend human fetal tissue (HFT) research in the U.S. The ISSCR submitted a letter to the U.S. Senate defending the ethics of HFT research and has lobbied against a policy rider in the U.S. House appropriations bill aimed at defunding certain forms of this research. In November 2023, the Goldstein Fellows published a review of HFT research in Stem Cell Reports, contributing to the ongoing efforts in this area. The authors will join Stem Cell Reports Editor-in-Chief, Martin Pera, on an episode of our podcast in early 2024.

Lastly, the ISSCR remains deeply involved in curbing the use and marketing of unproven cellular therapies. In 2023, the ISSCR led an effort to submit a brief of amicus curiae in support of the FDA’s ability to regulate human cells, tissues, and cellular or tissue-based products (HCT/Ps) in an appeal of U.S. v. California Stem Cell Treatment Center. Should the Ninth Circuit uphold the lower court’s decision against the U.S., it will be much more difficult for FDA to protect consumers by regulating stem cell clinics offering products that lack rigorous data on safety and efficacy. The ISSCR also continues to raise this issue with Congress and educate legislative staff on the harm these products pose.