The Center for Cell and Gene Therapy will interact with Basic Research and Clinical departments at Baylor College of Medicine and its affiliated hospitals to discover and develop novel therapies for a range of diseases. It is our intention to have the capability of moving basic pre-clinical discoveries into the clinical phase of development for initial evaluation in our patients. To allow this, we will have the resources to manufacture a wide range of viral and non-viral vectors to transfer genes of interest and the capability of separating and manipulating human cells. These combined genetic and cellular therapies should enable us to treat a range of conditions, both congenital and acquired, in almost every system of the body.
The Center for Cell and Gene Therapy at Baylor College of Medicine (BCM) was established at the beginning of l998 and consists of six components.
Located in the Alkek Tower of BCM is the Shell Center for Gene Therapy, where basic research activities to advance the field of gene therapy occur.
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.
The GMP Gene Vector Laboratory produces clinical grade vectors for use with Phase I/II clinical trials. The laboratory is one of three National Gene Vector Laboratories (NGVL) and will produce clinical vectors free for NGVL sponsored investigators. http://www.ngvl.org
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 llaboratory is a member of the Production Assistance for Cell Therapies (PACT) and will prepare cells for clinical use without charge for PACT sponsored investigators. http://www.pactgroup.net
The Stem Cell Transplantation Program. The 16,200 square foot pediatric unit is located 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 The Methodist Hospital, Main Tower.
The Protocol Office, which is located on the second floor of the Feigin Center, coordinates the submission of protocols and INDs to the appropriate regulatory agencies. This office is also responsible for the monitoring of the clinical trials as well as annual reviews.
The Center employs 30 clinical and research faculty and approximately 300 ancillary staff.
