The Center for Cell and Gene Therapy at Baylor College of Medicine was established at the beginning of 1998 and consists of six components:
Shell Center for Gene Therapy
Located in the Alkek Tower of Baylor is the Shell Center for Gene Therapy, where basic research activities to advance the field of gene therapy occur.
Translational Research Labs
The Feigin Center at Texas Children's Hospital houses both the Translational Research Labs, the pre-clinical research component and protocol monitoring functions and 12,000 square feet of Good Manufacturing Practice (GMP) Laboratories.
Gene Vector Laboratory
The Gene Vector Lab produces clinical grade vectors for use with Phase I/II clinical trials. The mission of the Center is to develop and implement novel cellular and gene-based treatments for a variety of diseases. Gene transfer vectors provide investigators important research tools in studies of gene function. They can make gene delivery easy and efficient in a number of models of disease. To these ends, the Center for Cell and Gene Therapy established a specialized Vector Development Laboratory (VDL). The VDL was established to function as a preclinical service and GLP manufacturing facility for gene therapy vectors for the CAGT. In addition, the CAGT also houses a Vector Production Facility which operates under current Good Manufacturing Practice (cGMP) guidelines.
Designated areas of the lab produce therapeutic grade monoclonal antibodies and plasmids. The resources of the VDL are available to every investigator at TMC as well as to outside investigators
Clinical Research Laboratory
The GMP Clinical Research Laboratory performs cell separations, expansions, processing and transductions related to preparing patient components for clinical trials. Clinical grade monoclonal antibodies and plasmid DNA are also produced in the GMP Labs. The GMP Laboratories comply with all the Federal standards and have a separate QA/QC section with its own lab space for safety testing of products and audits of the facilities and records. The laboratory is a member of the Production Assistance for Cell Therapies (PACT) and will prepare cells for clinical use without charge for PACT sponsored investigators.
Stem Cell Transplantation Program
The Stem Cell Transplantation Program is located in the 16,200-square-foot pediatric unit in the West Tower of Texas Children's Hospital on the eighth floor. The 30,000-square-foot adult unit is located on the eighth floor of Houston Methodist Hospital, Main Tower.
Clinical Research Program
The clinical research program consists of research and regulatory staff devoted to assisting in the development, implementation and conduct of clinical research protocols conducted by the Center for Cell and Gene Therapy. The regulatory component of the program assures that all regulatory approvals are obtained prior to initiating a protocol and throughout the life cycle of the research. The research staff help coordinate protocol driven care for patients enrolled to those protocols. The program also includes monitoring components to ensure that the studies are conducted safely and in compliance with all applicable regulations.