FACT Keeps Busy with Standards Development

Posted in :: 2016 Volume 2 :: Wednesday, October 12th, 2016

picture3Blood and marrow transplant programs continue to advance their field, cord blood banks look to maintain quality inventories and find new uses for cord blood, and oncology and regenerative medicine investigators are finding new ways to harness the power of cellular therapy. FACT does its part by drafting standards to support progress. FACT is especially grateful to the experts – from transplant physicians, oncologists, cardiologists, plastic surgeons, laboratory scientists, nurses, and quality managers – for keeping the spirit of FACT centered on expert and peer advice and leadership.

The following are updates from Standards development activities.

7th Edition FACT-JACIE Standards Under Development

The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is currently drafting the 7th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. The Steering Committee met in Barcelona, Spain in June 2016 to discuss what worked well under the 6th edition, opportunities for improvement, and new developments in the field that should be considered.

Subcommittees comprised of clinical, collection, processing, and quality management professionals are completing their first reviews this fall. Upon approval of the Steering Committee and the FACT and JACIE leadership, the draft will be published for public review and comment. The public comment period is planned for April through June 2017.

A full committee roster can be found on the FACT website.

FACT published a draft of the 1st edition FACT Standards for Immune Effector Cell Administration for inspection and public comment. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field. These Immune Effector Cell Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

In addition to the stand-alone set of Standards for non-blood and marrow transplant programs that use immune effector cells (such as a dedicated leukemia service), FACT also proposed the new requirements to be published as interim standards within the FACT-JACIE Hematopoietic Cell Therapy Standards.

Comments were solicited from a wide variety of stakeholders, from transplant centers, oncologists, professional and scientific societies, regulatory agencies, and drug manufacturers. The FACT-JACIE Standards Committee and the FACT Immune Effector Cell Task Force are reviewing the comments and making changes as appropriate. Final publication of the Standards is expected by the end of the year.

Although comments are no longer being accepted, the draft Standards and accompanying documents can be found online for review.

6th Edition NetCord-FACT Cord Blood Standards Become Effective

NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in July 2016, and the new requirements became effective at the end of September.

The most notable changes to the Standards was the inclusion of a list of required specifications for cord blood units stored for future clinical use. Specifications for both unrelated and related units related to cell counts, viability, potency, sterility, donor screening and testing, and identity are specified in Appendix V Specification Requirements for Cord Blood Units Stored for Clinical Administration. For related CB units, if specifications are unmet, the CBB at a minimum must follow its processes for deviations and nonconforming units in the event a customer insists on storage.

The Standards, Accreditation Manual, Summary of Changes, and supporting documents can be found on the FACT website.

FACT Takes First Steps Toward Standards for Cardiovascular Cellular Therapy

The FACT Regenerative Medicine Task Force is responsible for identifying new specialties for which cellular therapy is a viable option, and learn from experts in those fields how standards and accreditation may be of value. The task force chose to first explore cardiovascular cellular therapy, because of progress made in these trials and a demonstrated evidence of peer to peer collaboration in the field.

FACT has been working with the Cardiovascular Cell Therapy Research Network (CCTRN) to evaluate the FACT Common Standards for Cellular Therapies for applicability to cardiovascular cell therapy and to observe and learn from member institutions. The Interdisciplinary Stem Cell Institute (ISCI) of the University of Miami Miller School of Medicine, led by Joshua M. Hare, M.D., F.A.C.C., F.A.H.A, completed a self-assessment of its cardiac cell therapy program against the Common Standards and then hosted FACT on September 15, 2016. ISCI representatives Aisha Khan and Darcy DiFede led FACT representatives on a tour of all involved hospital departments, indicated how compliance with Standards would be documented for a cardiac patient, and discussed cardiac-specific requirements that might be considered for future standards.