CARMIT (Children’s Access to Regenerative Medicine in Texas) is a core service of the Cancer Prevention and Research Institute of Texas (CPRIT). Its aim is to provide cellular therapy products and viral vectors (retrovirus, adenovirus and plasmids) to treat pediatric cancer patients at Texas Academic Institutions. Manufacturing of these products must be performed under FDA regulations and Good Manufacturing Practices (GMP). The GMP facility at Baylor College of Medicine Center for Cell and Gene Therapy (CAGT) is one of the largest and most modern academic centers in the country. The staff is highly experienced in manufacturing a very wide variety of cellular therapy products and viral vectors used for genetic modification of cells. CARMIT will cover consultations regarding Chemistry, Manufacturing and Controls section of the Investigational New Drug applications with the FDA and some of the cost of making (mainly labor) of your product for your clinical trial. You will have to obtain funding for supplies and testing from other resources.
To be eligible to apply for CARMIT support you must be a physician scientist at a Texas Academic Center. Initial applications are short and are reviewed by a CAGT Internal Review Panel for scientific content and manufacturing feasibility. Successful applicants are then requested to submit a slightly longer application form describing the product to be made and the pediatric clinical protocol in which it is to be used, IND status etc. This is reviewed by an External Advisory Board composed of cellular therapy experts at renowned institutions. To apply, please complete the initial application located below, and submit it to Dr. Natasha Lapteva at nxlaptev@txch.org.
Successful applicants will work with a CARMIT representative to develop a manufacturing timeline and budget.
This work is funded by CPRIT Core Facilities Support Award RP240545 (renewal RP180785).
Applications
Primary Location
- Feigin Center at Texas Children's Hospital
- 16th Floor Offices and GMP facilities
- 17th Floor Translational Research
- 17th Floor Protocol & Regulatory Affairs
Services
Cellular therapy products manufactured include hematopoietic progenitor cells, donor leukocyte infusions, chimeric antigen receptor (CAR) T cells, virus and tumor specific T cells, NK and NKT cells, dendritic cells, and mesenchymal stromal cells. The staff will work with you to prepare the cell type used in your protocol.
Analytical services include all of the testing required to release the cell product or vector for clinical use. Testing is performed internally or contracted out to commercial testing companies. Multicolor and multiparameter flow cytometric analysis is performed on site. Manufacturing records are reviewed by our independent Quality Assurance group, who will generate Certificate of Analysis to facilitate clinical use of the products. All services are in compliance with GMP regulations as they apply to products used in Phase I/early Phase II clinical trials.
Products Manufactured
- Stem Cell Products for Transplant
- Virus-directed T cells
- Virus/Tumor-directed T cells
- NK cells (auto/allo/cell lines)
- NKT Cells
- Regenerative Medicine products (BM MNC & MSC )
- Viral vectors (Adenoviral and Retroviral), Master & Working Cell Banks
- Dendritic Cells
