The Center for Cell and Gene Therapy at Baylor College of MedicineTexas Children's Hospital and The Methodist Hospital has been renewed as a National Heart, Lung and Blood Institute cell processing facility. The facility assists scientists and physicians in the production of cellular therapies that help fight infection or repair tissues and organs damaged by disease.

The Center for Cell and Gene Therapy was one of three original facilities involved in a program called Production Assistance for Cellular Therapies, or PACT, which was established five years ago. The center has been renewed for an additional five years and will receive $12 million.

Advancing cellular therapy research

The objective of the PACT program is to advance cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, and biologic systems, and targeted treatments for serious diseases without effective therapies. The cell processing facilities will support translational research in novel cell therapies, to advance the field of cellular therapy and to enable basic science research to reach the clinical trial stage.

"Before this program, scientists and physicians had major issues getting cellular therapies into the clinics," said Dr. Adrian Gee, principal investigator of The Center for Cell and Gene Therapy lab. "To produce these cell therapies, you need specialized labs that are regulated by the U.S. Food and Drug Administration. The process was very difficult."

Dr. Cliona Rooney, professor of pediatrics – hematology and oncology at BCM, will serve as co-investigator of the lab.

To advance this process, while still complying with regulations, the NHLBI established national cellular therapy manufacturing labs that physicians and scientists can contract to produce their products.

Second phase of project

"The network turned out to be very successful," said Gee, also a professor of medicine and pediatrics – hematology and oncology at BCM. "It has established a great deal of collaboration between institutions in the Texas Medical Center and across the United States."

Over the past five years, Gee said the Center for Cell and Gene Therapy has produced cells used in clinical trials including cardiac stem cell therapies for the Texas Heart Institute at St. Luke's Episcopal Hospital, stem cells therapies for childhood brain injuries for Memorial Hermann Hospital, and therapies to eradicate viral infections following a transplant used in a large multi-institutional trial that included BCM, The University of Texas MD Anderson Cancer Center, Duke University, the Dana Farber Cancer Institute and Children's Hospital Los Angeles.

Cell processing facilities must apply and be approved by the NHLBI to become one of these special labs and submit a renewal application every five years.

With the second phase of the project, there are a total of five centers, including the Center for Cell and Gene Therapy, Center for Applied Technology Development at the Beckman Research Institute of City of Hope in Duarte, Calif.; Center for Human Cell Therapy in Boston; Molecular and Cellular Therapeutics Facility at the University of Minnesota in St. Paul; Waisman Clinical BioManufacturing Facility at The University of Wisconsin in Madison; The EMMES Corporation in Rockville, Md.

A new goal for the second phase is to bridge the gap in translational research by helping basic scientists get therapies into clinical trials faster, Gee said.

"We are very excited with continuing to support the cell therapy community and implementing new initiatives aimed at advancing the development of new cell therapies," said Dr. Traci Heath Mondoro, a project officer at the NHLBI.