Duke University Medical School is an international leader in both the science surrounding and the practice medicine in the cell therapy field. Innovative programs pioneering bone marrow transplantation using publicly donated umbilical cord had their start at Duke Medical Center. Additional interventions using a child’s own cord blood cells are being studied as well. These programs have continued and grown into a world renowned treatment center for children with inborn errors of metabolism as well as malignancies. In addition, a number of interventions in cancer therapy using the patient’s own cultured and modified immune cells are underway in both pediatric and adult studies. Basic research in these and other areas are turning attention to more and more primitive cell lines in order to craft effective, nontoxic treatments.
Applications in the field of cell therapy have grown requiring policy and regulatory oversight. An entirely new office was set up at the US Food and Drug Administration to provide regulatory oversight for this emerging field. The study and use of adult as well as more primitive human stem cells has grown providing many possible areas of discovery as well as areas for scientific, ethical and regulatory discussion. The Institute of Medicine of the National Academy of Sciences formed an expert committee and published guidance on how this oversight should be conducted. That guidance was the reference document for the Duke University Stem Cell Research Oversight Committee.
Beginning January, 2010, each cell therapy protocol submitted to the IRB or IBC will be concurrently reviewed by the Stem Cell Research Oversight group. Feedback will be sent to the investigator via the referring committee, IRB or IBC. If an investigator has a primitive stem cell line it must be registered in the Stem Cell Line Registry. A registry of stem cell lines will be kept by the dean’s office and each responsible investigator will be required to report on the activity with his/her line once a year.
For questions or assistance with stem cell research at Duke University, email Sally McCollum at cordbloodtherapyinfo@dm.duke.edu