Biography

James Sherley graduated from Harvard College (1980) and completed joint M.D./Ph.D. degrees at the Johns Hopkins University School of Medicine (1988). After post-doctoral studies at Princeton University, beginning in 1991 he led cancer cell molecular biology research at Fox Chase Cancer Center. In 1998, he began adult stem cell research at Massachusetts Institute of Technology, and in 2007 continued at Boston Biomedical Research Institute. In 2013, he founded the Adult Stem Cell Technology Center, LLC, (ASCTC), which he currently directs. ASCTC is developing technologies for mass-producing human tissue stem cells for applications in drug development and transplantation medicine.

Abstract

Modern medicine is now experiencing a deluge of unproven regenerative medicine treatments. Although there is considerable concern among stem cell scientists and physicians that many new cell therapies occur without the approval and supervision of government agencies like the Food and Drug Administration in the U.S., many new treatments are, in fact, being evaluated in certified clinical trials. However, even in the case of certified trials, there is ample reason to be circumscribed in expectations for them to yield meaningful progress. Because of patients’ and patient advocate groups’ high level of hope for relief from otherwise intractable and incurable ailments and disorders, the field of regenerative medicine is now propelled to act expediently to deliver the promises of stem cell medicine. This volatile situation engenders a high risk for the development of scientifically pre-mature clinical trials. In particular, cell transplantation trials driven more by factors of technical feasibility than by factors of biological plausibility should provoke concern regarding their likelihood to contribute to the success of regenerative medicine.