Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy

Kennedy Institute of Ethics Journal 22 (3):243-261 (2012)
Abstract
The transition of novel and potentially promising medical therapies into their initial human clinical trials can engender conflicting pressures. On the one side, because Phase I trials raise greater ethical and human protection challenges than later stage clinical trials, there is a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials, especially if the FIH trial involves significant risks. On the other side, scientists interested in having their research validated, corporations with a financial interest in the field, and potential patients and patient support groups desirous of having ..
Keywords info:mesh/Oligodendroglia  info:mesh/Embryonic Stem Cells  info:mesh/United States  info:mesh/Clinical Trials as Topic  info:mesh/Stem Cell Transplantation  info:mesh/Humans  info:mesh/United States Food and Drug Administration  info:mesh/Investigational New Drug Application  info:mesh/Spinal Cord Injuries  Oligodendroglia   Animals   Humans   Spinal Cord Injuries   Disease Models, Animal   Stem Cell Transplantation   Investigational New Drug Application   United States Food and Drug Administration   United States   Embryonic Stem Cells   Clinical Trials as Topic   Stem Cell Research  info:mesh/Animals  info:mesh/Stem Cell Research  info:mesh/Disease Models, Animal
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