Table 1.

Supporting research and innovation in regenerative medicine while protecting patients

Priorities	Summary of points covered in IAP statement
Ethical assessment	Ethical issues relate to uncertainty, patient consent, professional responsibilities, equity, and fairness. Concerns are evaluated further by Hermeren (2021) amid increasing momentum worldwide to discuss ethical issues. There are implications for professional training and constitution of ethics committees
Research in vitro and in animal models	Need for robust scientific foundation for clinical research and for ensuring consistency in composition and viability of a novel agent as it moves through successive stages of research and development
Clinical trials	Should be conducted according to approved design and monitoring procedures with transparency in data collection. The orphan nature of some rarer applications must be recognized in trial design to ascertain the acceptable level of evidence for safety and efficacy
Regulatory authorization and access to new medicines	Proportionate and consistent regulation must be based on replicable science and international development of standards as a step toward necessary regional and global regulatory coordination in addressing discrepancies (Qiu et al., 2020). LMICs must be included in global convergence on quality, efficacy, safety, and post-marketing surveillance (WHO, 2020)
Engaging with patients, policy makers, and the public	Notwithstanding the excellent work of the International Society for Stem Cell Research, there is more to be done to describe the difference between evidence-based practice and unproven, erroneous, and illegitimate practices. This requires an informed public and well-advised health professionals and regulators worldwide

For the IAP statement, see IAP (2021).