Children’s Access to Regenerative Medicine in Texas

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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).

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