Receiving this re-accreditation for its adult autologous hematopoietic progenitor and new accreditation of immune effector cellular therapies is an important milestone for the growing chimeric antigen receptor, or CAR, program and 33-year-old blood and marrow transplant program at Ascension Via Christi St. Francis.
Ascension Via Christi’s CAR program, offered in collaboration with Cancer Center of Kansas and the American Red Cross, is the only site in Kansas outside of the Kansas City metro area to offer this type of immunotherapy, which uses a person’s own modified cells to fight cancer.
FACT accreditation establishes the Cancer Institute at St. Francis, already an FDA-accredited site for CAR therapy, as a Center of Excellence, a requirement by many insurance companies.
“FACT accreditation has evolved into a necessary qualification in the field of cellular therapy,” says oncologist Bassam Mattar, MD, medical director for Ascension Via Christi’s cellular therapy programs. “It indicates that a program has all of the practices, policies and procedures in place to achieve the highest quality care for cellular therapy treatment programs.”
Keisha Humphries, director of Oncology Services at Ascension Via Christi, says achieving FACT accreditation will help with the continued development of its CAR program.
“We believe CAR T-cell and other ‘living drug’ cellular therapies are the future of cancer treatment,” says Humphries.
Currently, St. Francis is an approved CAR T-cell therapy site for Tecartus, used in treating adults with relapsed or refractory mantle cell lymphoma and refractory B-cell acute lymphoblastic leukemia; Yescarta, used in treating adults with relapsed or refractory large B-cell and follicular lymphoma; Breyanzi, used in treating relapsed or refractory large B-cell lymphoma; and Abecma, used in treating refractory multiple myeloma. Relapsed means a cancer has come back; refractory means it has stopped responding to treatment.
With these therapies, the patient's T-cells are collected and modified in a lab to produce a chimeric antigen receptor that helps immune cells recognize a certain cancer protein. The T-cells are then expanded and infused back into the patient to find and kill cancer cells with that protein.
FACT is an internationally recognized accrediting body for medical institutions offering stem cell transplant, and indicates the accredited institution has met the most rigorous standards in every aspect of stem cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration and cell release.
Demonstrating compliance with FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration is a rigorous process. It requires an extensive evaluation of submitted documentation and on-site inspection by leading experts in the field to determine if an organization is in compliance with current FACT standards and the United States Food and Drug Administration’s current rules for Good Tissue Practice.
FACT’s review at the Cancer Institute at St. Francis took place in January.
---Learn more about Cancer Care at Ascension Via Christi: http://ascension.org/ViaChristiCancerCare