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WVU Cancer Institute Cellular Therapy Program Recognized by the Foundation for the Accreditation of Cellular Therapy

Lauren Veltri, MD Director, WVU Cancer Institute Hematopoietic Malignancy and Cellular Therapy Program, discussed the recent FACT accreditation.

The West Virginia University Cancer Institute Hematopoietic Malignancy and Cellular Therapy Program was recently awarded its sixth consecutive Foundation for the Accreditation of Cellular Therapy (FACT) reaccreditation for blood and marrow transplant and first FACT accreditation for immune effector cell therapy (CAR-T).

By demonstrating compliance with the FACT International Standards for Hematopoietic Cellular Therapy, the WVU Cancer Institute Cellular Therapy Program has earned accreditation for adult allogeneic and autologous hematopoietic progenitor cellular therapy, immune effector cell therapy (CAR-T), marrow cellular therapy product collection, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation.

Established in 1992, the WVU Cancer Institute’s Osborne Hematopoietic Malignancy and Cellular Therapy Program has been FACT accredited since 2002 and has been re-accredited every three years since. It is the only provider of transplant and CAR-T cell therapy in the state of West Virginia – averaging 70 transplants a year and seeing a 78-percent increase in CAR-T cell treatments since 2019.

Founded in 1996, the Foundation for the Accreditation of Cellular Therapies (FACT) is an internationally recognized accrediting body for hospitals and medical institutions offering cellular therapies. This covers the entire spectrum of stem cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release.

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FACT accreditation signifies excellence in cellular therapy and demonstrates that the program has exceeded standards in patient care and laboratory services. This voluntary accreditation is based upon compliance with the most comprehensive standards in the field, verified by rigorous peer-reviewed inspections. Accreditation is attained through evaluation of submitted documentation and on-site or virtual inspection to determine if an organization is in compliance with current FACT-JACIE standards and the United States Food and Drug Administration’s current rules for Good Tissue Practice.

Inspections are carried out by a team qualified by training and experience who perform cellular therapy functions in their daily practice. FACT conducted a virtual evaluation of the WVU Cancer Institute Cellular Therapy Program on October 26, 2021.

FACT accredited programs offer experienced personnel who have undergone specialized training to understand and provide care for the unique needs of cellular therapy patients. An accredited program has policies and procedures in place for the safe administration of cellular therapy products that are required for optimum patient care outcomes. Also, when a program has received this accreditation, it assures that the processes in place are guided by a robust quality management system.

We are delighted that the WVU Cancer Institute Cellular Therapy Program has, once again, received FACT accreditation. It speaks to the dedication of the entire team and ensures that patients and families receive the best care possible.