About FACT Standards

The FACT Standards are the cornerstone of FACT's accreditation program. Built on the principle that quality care requires proactive management of both clinical and laboratory practices, FACT Standards are the only standards that emphasize the clinical use of cellular therapy products collected and processed under rigorous controls.

Developed by international committees of leading clinicians, scientists, technologists, quality experts, and regulatory liaisons, FACT Standards cover the full continuum of cellular therapies. This collaborative, evidence-based process includes public and legal review, ensuring requirements are comprehensive, consensus-driven, and rooted in published data or accepted scientific theory. The result is a detailed framework that safeguards product quality and therapeutic care worldwide.

FACT-JACIE Hematopoietic Cellular Therapy Standards

The objective of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products.

These Standards apply to:

  • Hematopoietic progenitor cells (HPCs): Self-renewing or multi-potent stem and progenitor cells from any tissue source (bone marrow, peripheral blood, umbilical cord, etc)

  • Nucleated/mononuclear cells: Collected from any hematopoietic tissue for therapeutic use beyond HPCs, which may be characterized or used in manufacturing cellular therapies

  • Immune effector cells (IECs): Cells capable of modulating specific immune responses, including diverse products with varying manufacturing methods, indications, and risk profiles

  • Genetically modified cells: Cells altered to replace, inactivate, or introduce genes to treat disease

Ninth Edition

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Eighth Edition

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Frequently Asked Questions: Standards for Immune Effector Cells

FACT-JACIE Immune Effector Cells Standards

The major objective of the FACT-JACIE International Standards for Immune Effector Cells is to promote quality practice in immune effector cell therapy.
These Standards are for programs that do not perform hematopoietic progenitor cell transplantation. Programs that perform both transplantation and immune effector cellular therapy should refer to the FACT-JACIE Hematopoietic Cellular Therapy Standards.

These Standards apply to:

  • Immune effector cells, used to modulate an immune response for therapeutic intent (such as dendritic cells, natural killer cells, T cells, and B cells)

  • Genetically engineered chimeric antigen receptor T cells (CAR T cells)

  • Therapeutic vaccines

Third Edition

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Other

Frequently Asked Questions: Standards for Immune Effector Cells

Second Edition

For additional resources, visit the Immune Effector Cell Resource Center

Explore

FACT Community Immune Effector Cell Standards

The major objective of the FACT Standards for Immune Effector Cells in the Community Clinical Setting is to promote quality medical practice in IEC therapy. These Standards are intended for community-based clinics not part of academia or large integrated health care systems that administer only autologous or allogeneic off-the-shelf cellular therapy products.

These Standards apply to:

  • Immune effector cells, used to modulate an immune response for the therapeutic intent (such as dendritic cells, natural killer cells, T cells, and B cells)

  • Genetically engineered chimeric antigen receptor T cells (CAR T cells)

  • Therapeutic vaccines

First Edition

Forms

Other

For additional resources, visit the Immune Effector Cell Resource Center

Explore

NetCord-FACT Cord Blood Banking Standards

Cord Blood Standards

The major objective of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration is to promote quality medical and laboratory practices throughout all phases of cord blood banking to achieve consistently high-quality cord blood units available to patients for lifesaving treatments.

These Standards apply to:

  • Cord blood units intended for unrelated allogeneic use and to related units collected and stored for allogeneic or autologous use by a donor family.

  • All phases of blood collection, banking, and release.

Eighth Edition

Forms

FACT Common Standards for Cellular Therapies

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 (eg, adipose tissue)

  • Cells collected from hematopoietic sources for non-homologous use (eg, mesenchymal stromal cells for cardiac repair)

Third Edition

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Ongoing Feedback on FACT Standards

As a standard setting organization, FACT welcomes ongoing feedback on its’ Standards and Accreditation Manuals which may be submitted at any time. FACT has a process to accommodate necessary changes between editions.

To submit your feedback on FACT Standards, email FACT at standards@factglobal.org.

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