Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products

Importancia y uso:

5.1 Cell Therapy Products may be used to treat clinical conditions, for example in regenerative medicine (e.g. type I diabetes, acute myocardial infarction, pediatric congenital heart disease, chronic ischemic heart failure, cancer, Crohn’s disease, chronic wound repair, nerve and spinal cord injury, musculoskeletal repair), and may be used for immunotherapy (e.g. graft versus host disease, CAR-T therapy).

5.2 Autologous, allogeneic, and xenogeneic cells may be used to make a product.

5.3 A product may be cells only, cells combined with an inert carrier, cells within an extracellular matrix, or cells within a synthetic scaffold, and will include tissue engineered medical products containing cells.

5.4 Cells may be gene-modified cells.

5.5 Cells may be adult or embryonic stem cells.

5.6 Cells may be minimally manipulated.

Subcomité:

F04.44

Volúmen:

13.02

Número ICS:

11.020.20 (Medical science)