An integrated medical team housed in geographically contiguous or proximate space with a single Clinical Program Director and common staff training programs, protocols, and quality assessment systems.  The Clinical Program shall use hematopoietic cell collection and processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Clinical Program.  Clinical programs that include non-contiguous institutions in the same metropolitan area shall demonstrate common protocols, staff training procedures, quality management systems, review of clinical results and evidence of regular interaction.  Several clinical sites, particularly with different Directors, or outside a single metropolitan area, joining together for the purpose of meeting criteria to qualify as a Clinical Program do not fulfill the intent of these Standards.  In contrast, collection facilities and/or processing facilities serving one or more clinical programs are acceptable.

A strain of genetically identical cells descended in culture or in vivo from a single cell.

Clusters of differentiation (CD) are groups of monoclonal antibodies that identify the same cell-surface molecule.

Cytomegalovirus

Any procedure for harvesting cellular therapy products, including labeling, regardless of technique or source.

Refers to the sum of CFU-E, CFU-GEMM and CFU-GM.

Further differentiated precursor than BFU-E, forming only erythroid elements in culture.

Precursor cell that in vitro forms cells of both granulocytic and macrophage morphology.

Hematopoietic precursor cells that in vitro form colonies containing cells of the indicated lineages.

Any one of a number of peptides able to stimulate the growth of hematopoietic colonies in vitro. Includes: G-CSF, GM-CSF, SCF, and IL-3.

Ability to adequately perform a specific procedure or task according to direction.

Any written, oral, or electronic communication about a problem associated with a distributed cellular therapy product or with a service related to the collection, processing, storage, distribution, or infusion of a cellular therapy product.

A multi-component enzyme system present in plasma that acts together to induce the lysis of targeted cells.  This system may be activated directly by certain pathogens (alternative pathway) or secondary to certain subclasses of antibody binding to a cell surface.  Antibodies of the IgG2, IgG3 and IgM subclasses activate complement most readily.

Soiled or infected by microorganism(s).

A device that measures the temperature of the environment on a continuous basis over time and captures and stores temperature data at defined intervals.

Freezing of biologic material at a predetermined rate; to decrease in temperature at designated rate per minute.

The whole blood including hematopoietic progenitor cells, collected from placental and umbilical cord blood vessels after the umbilical cord has been clamped.

Facility in which hematopoietic progenitor cells collected from the placental and umbilical cord blood vessels are processed, cryopreserved and/or stored.  For purposes of FACT Standards, a Cord Blood Bank is considered a laboratory facility.

Cell Processing Laboratory

Points or where things can go wrong.  These represent major or critical process within the system, the correct performance of which is required to ensure the quality of the finished product or service.