5. Standards in Stem Cell Research
Translation of cell-based interventions is a collaborative endeavor among scientists, clinics, industry, regulators, and patients. Standards help enable such collaborations and support efficient clinical translation in many ways. For instance, they allow scientists to compare the outcomes of trials and enable clinics to reproduce treatments reported in published studies. Regulatory standards also reduce the costs of uncertainty for private actors, facilitate an independent review, and engender trust among patients.
Recommendation 5.1: Researchers, industry, and regulators should work towards developing and implementing standards on design, conduct, interpretation, preclinical safety testing, and reporting of research in stem cell science and medicine.
There are numerous areas where standards development would greatly advance the science of stem cells and its clinical application. Gaps and priorities for standard developments should be extensively and thoroughly studied to meet the rapid advancement of stem cell science and medicine. Particular opportunities topics include but not limited to standards for:
- Source materials: (a) consent, (b) procurement, (c) manufacturing regulations, (d) cell potency assays primary quality attributes, (e) reference materials for calibrating instruments;
- Process controls: (a) detection and inspection, (b) biobanking of stem cells, (c) minimally acceptable changes during cell culture, (d) method of delivery and selection of recipients for novel stem cell-based interventions, (e) reporting of animal experiments, (f) design of trials, (g) reporting of trials, (h) principles for defining information in datasets as “sensitive” such that there is a justified withholding or delay of study reporting.
- Instrument, facility, environment and personnel;
- Analytical methods; and
- Data processing.
Scientists, regulators, funders, patient groups, and others involved in stem cell research should collaborate on the timely development of standards for stem cell research and translation. To promote common and universal standards for consent and procurement of biomaterials, the ISSCR has provided template donor consent forms (Appendix 2).
Revisiting the ISSCR Guidelines
Recommendation 5.2: The ISSCR guidelines should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.
New scientific opportunities and ethical challenges in the conduct of stem cell research and stem cell-based interventions that are on the horizon must be addressed in a timely manner to ensure that science and medical care proceed in a socially responsible and ethically acceptable fashion. Periodic revision enhances the likelihood that the international scientific research community will be bound together by a common set of principles governing the performance of stem cell research.