Regulating the stem cell industry: needs and responsibilities

Unproven stem cell interventions: A global public health problem requiring global deliberation

“…Taking cues from the recent endeavor of the World Health Organization (WHO) to consider the ethics and practice of human genome editing, we suggest that a similar approach may be adopted to tackle the issue of the worldwide marketing of unproven SCIs. While our proposal outlines a specific initiative, our goal, however, is for the scientific community to consider the issue beyond one or a few largely independent organizations operating in one or more countries and to adopt a more global outlook to successfully tackle this problem ( Lee et al., 2017 ; Sipp et al., 2017 ).…”

“…WHO has the authority to establish collaborations; assist governments; propose conventions, regulations, and agreements; provide recommendations and technical guidance; and improve standards. It promotes cooperation among different nations, specialized agencies, scientific and professional groups, and assists in establishing a common set of norms and product development standards ( Lee et al., 2017 ). It is the only global health organization where each nation state has one vote offering it a unique form of legitimacy when convening its authority over policy decisions on international health matters ( Kickbusch and Hein, 2010 ).…”

“…Multiple scientific, ethical, legal, and social issues impact the responsible translation of stem cells and regenerative medicine ( Abou-El-Enein et al., 2015 , 2014 ; Bauer et al., 2018 ). A WHO EAC on Regenerative Medicine could address several issues, including standardization of regulatory definitions and practices; the need for robust scientific data on the safety and efficacy of cell-based therapies balanced with patients' unmet medical needs; adequate protection of participants in first-in-human regenerative therapy trials; and informing patients and clinicians in an area of substantial misinformation ( Chan, 2017 ; Lee et al., 2017 ; MacPherson and Kimmelman, 2019 ; Richardson et al., 2020 ; Sipp et al., 2017 ). A WHO expert panel should prioritize those topics related to the unproven SCI industry that create the most harm to patients and the regenerative medicine community.…”

Quality assurance and adverse event management in regenerative medicine for knee osteoarthritis: Current concepts

“…The WHO, U.S. Food & Drug Administration, and others have called for the development of a rigorous evidence base for the treatment of Knee OA with regenerative products in order to guide regulatory decision-making and the development of safe, efficacious, and cost-effective products. 19,25 Guidance for clinical research and translation of regenerative medicine is essential. Numerous convincing safety studies, 20,26e28 which often involves autologous products which do not pose the potential for disease transmission and host-donor rejection as do other transplantations, have brought about the emergence of a regulatory 'gray area' where many clinicians and clinical researchers find themselves today.…”

“…2) of: reporting of Adverse Events (AE), Regulatory Approval (IRB), Outcome with regard to the regenerative medicine technology of interest (Outcome), reporting of Adverse Events (AE), mention of cost/benefit analysis and cost efficiency (Value). 19,25,29 In 32 of the 35 papers evaluated, researchers reported that they had sought and received the approval of their local institutional review board (IRB). Data from prospective patient registries were found in four papers in our sample.…”