Human Gene and Cell Therapy Program at UCLA
The UCLA Human Gene and Cell Therapy Program (HGCTP) is a collaborative effort of the David Geffen School of Medicine, the Jonsson Comprehensive Cancer Center, and the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research. The HGCTP provides scientific, safety, and quality assurance oversight of all Human Gene Transfer Clinical Trials conducted at UCLA and supports a manufacturing facility for cell and gene transfer products. More details are available in the HGCTP policy.
Approval by Institutional Bodies
All UCLA Human Gene Transfer research must be approved by the following institutional bodies before work can begin:
- Institutional Review Board (IRB)
- Jonsson Comprehensive Cancer Center (JCCC) Internal Scientific Peer Review Committee (ISPRC) for oncology studies or UCLA Scientific Review Committee (SRC) for non-oncology studies
- Institutional Biosafety Committee (IBC) (See UCLA Policy 992 and IBC Requirements for Human Gene Transfer (HGT) Studies)
- Medical Radiation Safety Committee (MRSC), if applicable
Scientific and Quality Assurance Oversight
Scientific review, data, and safety monitoring and quality assurance must be completed.
- The JCCC ISPRC for oncology clinical trials and the UCLA SRC for non-oncology clinical trials, will review the clinical protocol, statistical plan, and other factors such as adequate staffing, competing trials, etc.
- In addition to scientific integrity, the committees also review data and safety monitoring plans for the studies and if necessary, recommend trial oversight by their respective data and safety monitoring board (DSMB).
- All studies overseen by an institutional DSMB are subject to monitoring and auditing by the quality assurance officers within either the JCCC or the Clinical and Translational Science Institute (CTSI).
For more information regarding scientific review, DSMB services and quality assurance oversight, please see the JCCC ISPRC website, the JCCC DSMB website and the CTSI ORA website.
Required Training
All UCLA Key Personnel involved with Human Gene Transfer Clinical Trials must have completed and be up to date with the following courses offered through the Collaborative Institutional Training Initiative (CITI) program:
- Biomedical Good Clinical Practice Training (See UCLA Policy 917);
- NIH Recombinant DNA Guidelines*; and
- Human Gene Transfer*.
*Training is valid for 3 years.
Manufacturing of Gene Transfer Products
The UCLA Human Gene and Cell Therapy Facility (HGCTF) supports manufacturing of gene and cell therapy products for UCLA Principal Investigators as well as other academic and industry partners conducting Clinical Trials in which a cell or gene therapy product is manufactured under an FDA IND. For more information, see the HGCTF website: https://medschool.ucla.edu/research/human-gene-and-cell-therapy-facility
Contact Information
- For non-oncology studies, contact the Clinical and Translational Science Institute (CTSI) Office of Regulatory Affairs (ORA): ctsiora@mednet.ucla.edu
- For oncology-related studies, contact the Jonsson Comprehensive Cancer Center (JCCC) Internal Scientific Peer Review Committee (ISPRC): CORA@mednet.ucla.edu
- For questions related to manufacturing a cell or gene transfer product, please contact the Human Gene and Cell Therapy Facility: GMP@mednet.ucla.edu
- For questions about Institutional Review Board (IRB) review and approval, contact the MIRB at mirb@research.ucla.edu
- For questions about Institutional Biosafety Committee (IBC) review and approval, contact the IBC administrative staff: ibc@research.ucla.edu
- For questions about the Medical Radiation Safety Committee, contact the RSC administrative staff: rsc@research.ucla.edu
HGCTP and UCLA Oversight Committees
*Oversight includes:
1. Scientific Review of Protocols
2. Data and Safety Monitoring
3. Quality Assurance (Monitoring and Auditing of Trial Conduct)
4. Training