Risk of tumorigenesis in first-in-human trials of embryonic stem cell neural derivatives: ethics in the face of long-term uncertainty
Hess, Pascale H.
Accountability in Research 2009 May-August; 16(3-4): 175-198
While the successful differentiation of human embryonic stem cells into high purity populations of specialized cells is viewed as a major step towards the safety of prospective human transplantation trials, concerns about the possible risks of tumor formation remain. The potential tumorigenicity of transplants derived from embryonic stem cells raises distinctive ethical challenges regarding trial design, evaluation of their risks to potential benefits ratio, population selection, and post-trial subject monitoring. These challenges are examined within the context of foreseen trials for disorders of the central nervous system.
Cells; Embryonic Stem Cells; Ethics; Evaluation; Risk; Stem Cells; Transplantation; Uncertainty; Genetics, Molecular Biology and Microbiology; Human Experimentation Policy Guidelines / Institutional Review Boards; Informed Consent or Human Experimentation; Stem Cell Research; Artificial and Transplanted Organs or Tissues; Research on Embryos and Fetuses;
Showing items related by title, author, creator and subject.
Bretzner, Frédéric; Gilbert, Frédéric; Baylis, Françoise; Brownstone, Robert M (2011-05-06)Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding ...
Response to Frederic Bretzner Et Al. "Target Populations for First-in-Human Embryonic Stem Cell Research in Spinal Cord Injury" Wirth, Edward 3rd.; Lebkowski, Jane S; Lebacqz, Karen (2011-05-06)We address concerns raised in this issue by Bretzner et al. (2011) by explaining the rationale for including subjects with subacute, neurologically complete spinal cord injuries in the Phase 1 trial of GRNOPC1. We also ...