Background Transplantation of cells derived through the manipulation of pluripotent stem cells may involve great uncertainty and the possibility of serious risks.
Purpose To develop guidelines for the ethical conduct of clinical trials using such stem cells.
Methods Review of literature on clinical trials ethics and clinical applications of stem cells; critical deliberation on potential guidelines.
Results Such transplantation should be allowed in clinical practice only after clinical trials demonstrate efficacy and safety. These clinical trials should follow ethical principles that guide all clinical research. Additional requirements to strengthen trial design, coordinate scientific and ethics review, verify that participants understand key features of the trial, and ensure publication of findings are also warranted because of the highly innovative nature of the intervention, limited experience in humans, and the high hopes of patients who have no alternative effective treatments.
Limitations These recommendations will need to be modified in light of actual experience with stem cell clinical trials.
Conclusions These recommendations will help guarantee that the efficacy and safety of innovative stem cell interventions will be rigorously established, while also protecting study participants. Clinical Trials 2008; 5: 517—522. http:// ctj.sagepub.com
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