Requirements relating to HPCs and bone marrow were first introduced in the 14th edition of Standards for Blood Banks and Transfusion Services in 1991. In 1996, the AABB published the 1st edition of Standards for Hematopoietic Progenitor Cells, and in 2001 the 1st edition of Standard for Cord Blood Services. In 2004 the HPC Standards and the Cord Blood Standards were merged into the 1st edition of Standards for Cellular Therapy Product Services. The CT Standards is revised and published on a 24-month cycle. The Cellular Therapy Standards Program Unit, has completed work on the sixth edition which is now available for purchase.
The sixth edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities. Significant changes:
New and enhanced standards that address clinical activities, including but not limited to standards about patient consent, patient care, preparation for administration, and clinical outcomes reporting.
Restructured Chapter 5 Process Control to divide the chapter into four distinct areas of focus: general process control, procurement activities, processing activities, and clinical activities.
Expanded non-hematopoietic content addressing elements of novel cellular therapies.
Several revisions to assist in the international application of the standards.
The 6th edition will become effective on July 1, 2013.
A summary of changes to the Standards for Cellular Therapy Services, 6th edition is now available. The summary details the edits made to the 6th edition.
Visit AABB for ordering information.