Human cells, tissues, and cellular and tissue-based products (HCT/Ps) consist of human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient. The Food and Drug Administration regulates a cellular therapy product solely as an HCT/P (i.e. "361 product") if it meets all the following criteria in 21 CFR 1271.10(a):

  • The product is minimally manipulated.
  • The product is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent.
  • The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article — except for water, crystalloids or a sterilizing, preserving or storage agent — provided that the addition of water, crystalloids or the sterilizing, preserving or storage agent does not raise new clinical safety concerns with respect to the HCT/P
  • And either: 
    • Does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, or
    • Has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is for
      • Autologous use
      • Allogeneic use in a first or second-degree relative or
      • Reproductive use.

HCT/Ps are subject to the regulations in 21 CFR 1271 including establishment registration, donor eligibility (donor screening and testing), Current Good Tissue Practice (CGTP), additional regulatory requirements (adverse reaction reporting, HCT/P deviation reporting and labeling), and exemptions and alternative procedures. The regulatory requirements for allogeneic products are more extensive than for autologous products but, in general, FDA regulations emphasize preventing the risk of communicable disease transmission by HCT/Ps. Premarket review (licensure, clearance, and approval) by the FDA is not required for HCT/Ps.

Examples of HCT/Ps are listed below:

  • Bone
  • Heart valve
  • Manipulated autologous chondrocytes
  • Ligament
  • Cornea
  • Hematopoietic progenitor(stem) cells (HPC) from peripheral and cord blood
  • Skin
  • Semen
  • Decellularized particulate human placental connective tissue matrix
  • Epithelial cells on a synthetic matrix
  • Other reproductive tissue
  • Dura mater

AABB's Standards for Blood Banks and Transfusion Services defines accreditation requirements for facilities involved in collecting, processing, distributing, and transfusing blood and blood components. Because blood centers and transfusion services may store and dispense tissues (i.e., bone, ligament, and skin), these products are addressed in the general quality system requirements of the AABB Standards. Although the FDA requires tissue banks to track tissues from the donor to the consignee (or final disposition), hospitals are considered exempt from this requirement. AABB and other standards and accreditation programs have been working to implement ISBT-128 labeling — a standardized system widely used in the blood banking, tissue and cellular therapies industries — to preserve the traceability of tissue products. Activities related to the preparation and dispensing of tissues and associated record-keeping requirements are addressed in AABB's Standards.

HPCs can be obtained from different sources (marrow, cord blood, peripheral blood) and are used in a variety of therapeutic applications. HPC from marrow is regulated by the Health Resources and Services Administration, and HPC from peripheral blood collected by apheresis is regulated as an HCT/P.

Effective Oct. 20, 2011, minimally manipulated HPCs sourced from placental/umbilical cord blood for unrelated allogeneic use require a biologics license application prior to marketing, or they must be distributed under an Investigational New Drug . Read more about how these HPC, Cord Blood products are regulated as biological products in addition to relevant HCT/P regulations.