The Foundation for the Accreditation of Cellular Therapy (FACT) recognizes MedStar Georgetown University Hospital for excellence in adult allogeneic and autologous hematopoietic progenitor cellular therapy, Immune effector cellular therapy, and marrow and blood donation process
WASHINGTON –The MedStar Georgetown University Hospital Stem Cell Transplant and Cellular Immunotherapy Program, Blood and Marrow Collection Program, and Cell Therapy Manufacturing Facility have been accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) for the next three years. MedStar Georgetown University Hospital remains the Washington, D.C. area’s only adult, FACT-accredited program for allogeneic and autologous transplantation, and cellular immunotherapy.
FACT has established and maintained the highest standards for medical practice in cellular therapies since 1996 and is the only international standard used in the United States, Canada, and several other countries. Their independent and thorough inspections and strong requirements encompass the entire cellular therapy process, from collection and processing to storage and, eventually, administration to a patient.
“Receiving FACT accreditation reaffirms our goal of putting the patient first and consistently prioritizing quality patient care and high standards in every aspect of our collection and transplantation process,” said Scott Rowley, MD, director, Stem Cell Transplant and Cellular Immunotherapy Program, MedStar Georgetown University Hospital. “FACT accreditation demonstrates the dedication to quality of MedStar Georgetown University Hospital. Patients throughout their transplant process can be assured that safety is a priority, as shown by our adherence to the thorough standards that FACT requires all accredited programs to follow.”
MedStar Georgetown University Hospital’s Blood and Marrow Collection Program is the highest capacity and volume marrow collection site in the nation, performing over 30 percent of the total marrow collections in the country for the National Marrow Donor Program® (NMDP)/Be The Match®. Since its inception in 1993, the program has cared for more than 4,000 bone marrow donors and more than 2,500 stem cell donors. In the past year alone, they coordinated the care of more than 380 stem cell and marrow donors, registered through the NMDP. These stem cell transplants and cell therapies are used as treatments for cancers affecting the blood or immune system (such as leukemia, lymphoma, and myeloma) and other blood disorders. The team works with several departments throughout the hospital, such as the Cardiovascular Pulmonary Procedure Lab, Apheresis, Anesthesia, post-anesthesia care unit, and Cell Therapy Manufacturing Facility (CTMF). That cooperation relies on the collective commitment and goal of providing donors with a positive experience and providing recipients a chance at life.
The MedStar Georgetown Stem Cell Transplant and Cellular Immunotherapy Program includes a dedicated 18-bed hematology/oncology/stem cell transplant unit, a state-of-the-art, fully equipped outpatient stem cell transplant and cell therapy clinic, and a dedicated team of stem cell transplant and cell therapy coordinators serving as the primary contact between them, the medical team, and the patient and family. The clinical program, which is part of Georgetown Lombardi Comprehensive Cancer
Center, works in collaboration with the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey to help deliver comprehensive, advanced care to patients. In addition to the adult allogeneic and autologous hematopoietic progenitor cellular therapy facilities and processes, and immune effector cellular therapy processes, FACT also inspected MedStar Georgetown University Hospital’s marrow cellular therapy product collection process, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal and more than minimal manipulation.
The MedStar Georgetown University Hospital Cell Therapy Manufacturing Facility (CTMF) has been re-accredited by FACT this year—meeting high-quality standards for cell product manufacturing—and serves as the bridge between donors and recipients in transplantation. The CTMF is responsible for manipulation, packaging, labeling, and storage (cryopreservation), or distribution of human cellular products. Also, the CTMF personnel perform microbial testing and analytical testing to gauge the potency and purity of each product prior to administration of the product to the patient. To highlight, the CTMF manufactures hematopoietic progenitor cells (minimal manipulation) for the MedStar Georgetown University Hospital Stem Cell and Cellular Immunotherapy Program and human pancreatic islets (more than minimal manipulation) for the MedStar Georgetown Transplant Institute Autologous Islet Transplantation program.
All stem cell products collected at MedStar Georgetown University Hospital by our Blood and Marrow Collection Program for the NMDP come through the CTMF for analysis. It is the busiest NMDP-affiliated collection center in the United States. In 2021 alone, over 450 products came through the lab for analysis.