The MC3 team works with departments and patient populations across Duke University Hospital (DUH) to bring cell therapies to the bedside. Their expertise in study startup, development of procedures, and clinical knowledge support the successful conduct of complex and cutting-edge clinical research. The team works with both Duke Sponsor-Investigators and commercial sponsors to carry out all aspects of a study at DUH, including patient visits, adverse event evaluation, data collection and submission, and regulatory documentation. The team is experienced in administering cell therapies via both peripheral and intrathecal routes, and has worked on protocols involving MSCs, cord blood, CAR-T cells, DUOC-01 (a cord blood derived cell), NK cells, AAV-based gene therapy, and cell-based gene therapy, among others. [insert link to clinical trials page of website]
In addition to conducting clinical research studies, MC3 has expertise in screening Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) and helps sponsors and clinicians develop and implement FDA compliant donor screening procedures. Current projects include screening donors for commercial cultured thymus tissue implantation and partial heart transplantation.
If you are an investigator or sponsor interested in working with MC3 to conduct your clinical trial or screen HCT/P donors, please contact marcuscenter@duke.edu