On 1 May, 2017, JACIE published the draft seventh edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration for Hematopoietic Cellular Therapies for public consultation and comment for a 90-day period. Comments were accepted from May 1, 2017 through July 30, 2017.
Anyone working in the transplant or cellular therapy sector was strongly encouraged to participate, including physicians, data managers, nurses, quality managers, laboratory directors, technicians and operators and regulators. Submission could be made as individuals or groups. Participants were also encouraged to distribute the draft edition among their colleagues for their information. Professional societies, associations and groups were requested to alert their members to this consultation.
These Standards apply to all phases of collection, processing, storage, and administration of haematopoietic cellular therapy products. This includes haematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood, and administered by an accredited blood and marrow transplant team.
The consultation period closed earlier this year and the 7th edition JACIE standards were released March 1st, 2018. The documents are included here for your reference. The final version of the JACIE Standards 7th Edition will go into effect in June 2018.