The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. They represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. These Standards apply to:
- Cells collected from non-hematopoietic sources (e.g., adipose tissue).
- Cells collected from hematopoietic sources for non-homologous use (e.g., mesenchymal stromal cells for cardiac repair).
therapy is an emerging and evolving field. Through these Common Standards, FACT
is expanding its services to facilities utilizing cellular therapy products to
improve outcomes in patients suffering from a variety of diseases and
conditions. Ideally, various discipline-specific or product specific standards
would be added in the future with the input, collaboration, and acceptance of
those experts actively involved in the field and their clinical and laboratory
programs that volunteer to comply with them.
Standards are not intended to apply to hematopoietic cellular therapy programs
or to cord blood banks. More detailed and specific standards already exist for
both these disciplines, and FACT accreditation based on these specific
standards is available.
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