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 , https://duke.qualtrics.com/SE/?SID=SV_3VIw7b1qLwNkNBa. 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.
Duke University Stem Cell Research Oversight Committee
This committee charter describes the organization work process and principles for review of protocols for cell therapy at Duke University. It gives the names of the committee members and the flow diagrams for the review paths for both clinical and basic science cellular research.
National Academy of Sciences Report: Human Embryonic Stem Cell Research Advisory Committee, National Research Council and Institute of Medicine of the National Academies, 2008
This document provides guidelines for the review and management of embryonic and pluripotent stem cell research. It contains definitions of the varieties of cell lines that should be reviewed as well as guidance on record-keeping and storage of stem cell lines. It gives guidance as to the informed consent process that must be in place for the embryo donor/parents to undergo. This includes lines donated for basic as well as clinical research.
National Institutes of Health Guidelines for Human Stem Cell Research
These guidelines were published as the basis of review for newly proposed embryonic stem cells lines applying for federal funding. They were released July 7, 2009, after a period of public comment. They have now been used to qualify 11 new lines for eligibility for US funded research.
Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research
On August 25, 2009, this form was released By the NIH to allow investigators to apply for approval of stem cell lines.
Guidelines for the Conduct of Human Embryonic Stem Cell Research, International Society for Stem Cell Research, 2006
These guidelines are similar to the Institute of Medicine guidelines listed on this page, but are international in scope broader in policy and less prescriptive on specifics such as how stem cell lines should be stored and shipped.