Stem Cell Trials: Lessons from Gene Transfer Research

摘要: Since 1998, when James Thomson and John Gearhart reported the first successful derivation of human embryonic stem cells germ cells, respectively, scientific community has championed therapeutic potential these cells. Indeed, despite restrictions on embryo research in some jurisdictions recent controversy surrounding validity cell conducted by Woo Suk Hwang, may soon enter their trials--possibly within a year. Stem transplantation will not be biotechnology to begin trials amid revolutionary expectations moral apprehension. More than fifteen years ago, experiments with gene transfer somatic inspired similar hopes fears. Gene quickly evolved into competitive area, but its progress was checked ethical missteps. With poised trials, now is an opportune time for scientists ethicists review transfer's miscues. Moving Too Quickly From protocol involving humans, caught up controversy. In 1980, hematologist Martin Cline began without prior approval from his institutional board (IRB); neither National Institutes Health (which supported study) nor committees at collaborating institution Israel were apprised fact that protocols involved recombinant DNA. The studies faulted prematurity, became clinical investigator formally sanctioned NIH violating subjects regulations. 1992, another erupted recommended canceling contract prominent researcher, Steven Rosenberg, pursuing sufficient preclinical data. Episodes like created early impressions researchers moving too aggressively. There are various indications have fully absorbed cautionary lessons. As this essay goes press, cloning pioneer Hwang admitted improprieties obtaining eggs under investigation fraud. Elsewhere, two different groups (one backed Geron, other ES Cell International) reportedly nearing concerns expressed many about safety prematurity such trials. Scientific Value suffered setback 1995 NIH-commissioned concluded only minority ... [had] been designed yield useful basic information." report emphasized initial "exploratory" "many therapy thus far met [high] standards [of experimental design]." Because novelty, necessarily involve high levels indeterminacy regarding risks, methods, standards. Considering uncertainty, move animal requires questions asked answerable using vitro or models, second, so as maximize knowledge. Moreover, participants unlikely benefit directly. Maintaining favorable ratio harms benefits, required all major codes ethics, demand exacting phase I care selection participants. Therapeutic Misconception Patient advocates often misconstrued aimed delivering therapy, frequently contributed conflation therapy. However, impose requirements (for example, studies, doses administered anticipated subtherapeutic) abrogate medicine's mandate provide personalized care. …