Scientific Publications by FDA Staff

J Transl Med 2010 Mar 29;8:31

Cell and gene therapies: moving from research to clinic.

Stroncek DF, Puri RK

Cell and gene therapy clinical trials began more than 40 years ago. At some institutions cellular therapy laboratories were started to support marrow transplantation. These early laboratories removed red blood cells and plasma from aspirated bone marrow that was used for allogeneic transplants, cyropreserved autologous marrow and depleted T cells from allogeneic grafts and depleted leukemic or cancerous cells from autologous grafts [1]. At other institutions cellular therapy laboratories were started to isolate and expand tumor infiltrating lymphocytes (TIL) that were used as investigational treatments for patients with melanoma or to prepare transfected autologous lymphocytes to treat severe combined immune deficiencies.