FACT has published the draft sixth edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration for Hematopoietic Cellular Therapies for inspection and public comment for a 90-day period. Comments will be accepted from April 30, 2014 through July 24, 2014.

 

These standards apply to hematopoietic progenitor cells, defined as self-renewing and/or multi-potent stem cells capable of maturation into any of the hematopoietic lineages, lineage-restricted pluri-potent progenitor cells, and committed progenitor cells from hematopoietic sources (bone marrow, umbilical cord blood, peripheral blood, or other tissue source). These Standards also include mononuclear cells, defined as nucleated cells from any hematopoietic tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as hematopoietic progenitor cells. The Standards apply to all phases of collection, processing, storage, and administration of these cells, including various minimal manipulations such as removal or enrichment of various cell populations and cryopreservation.

 

FACT will also publish the draft first edition Common Standards for Cellular Therapies for public review and comment soon. The Common Standards are derived from current editions of FACT-JACIE Cellular Therapy and NetCord-FACT Cord Blood Standards, and are intended to represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application and more than minimal manipulation. Instructions for submitting comments on those Standards will be announced when the draft is published.

Draft FACT-JACIE Standards

The Hematopoietic Stem Cell Transplant arm of the ASHI National Clinical Affairs Committee have prepared an official ASHI response to the 6th edition of the FACT-JACIE Standards. Click here to read ASHI's official comments in their entirety.

To submit your own comments for the draft FACT-JACIE Standards, follow the steps below. Comments will be accepted until July 24, 2014.

1. Access the Comment Form at http://www.surveymonkey.com/s/HCTcomments

2. Type in your contact information and comments on the form. Fill in all fields so that the Standards Committee fully understands your position.

3. Submit the form when finished. Once the form is submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.

Again, the deadline for submission of comments is July 24, 2014.

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