Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development

Table 1 Type of somatic cells employed in specific advanced therapy medicinal products (ATMPs)

ATMP	Intended use	Cells	Applications	Action in the tissue
GTMPs	The focus is primarily on the genetic material that is delivered into the patient’s cells to correct or replace defective genes	Terminally differentiated: T-cells	Often modified for cancer immunotherapy (e.g., CAR-T cells)	They can be performed in vivo (directly in the patient) or ex vivo (cells are modified outside the body and then reintroduced), which are leading to therapeutic, prophylactic, or diagnostic effect
		Hematopoietic stem cells	Used for genetic disorders affecting blood cells
SCTMPs	Can involve cells that have been manipulated to alter their biological characteristics for therapeutic purposes, not intended to be used for the same essential function(s) in the recipient as in the donor	Terminally differentiated: Like fibroblasts and chondrocytes	Which are used for repairing specific tissues	They can repair or replace damaged tissues or to treat diseases, which are leading to therapeutic, prophylactic, or diagnostic effect. Unlike GTMPs, somatic cell therapy does not necessarily involve genetic modification but rather the application of cells to restore function
		Mesenchymal stem cells: Isolated adult tissues	These cells are known for their ability to differentiate into various cell types and are used in regenerative medicine
		Induced pluripotent stem cells: These are reprogrammed adult cells	Can differentiate into any cell type, providing a versatile option for therapy
TEPs	Cells that are used in combination with scaffolds to create functional tissues, not intended to be used for the same essential function(s) in the recipient as in the donor	Progenitor: Such as those derived from stem cells	Can differentiate into specific tissue types	They are designed to repair, regenerate, or replace damaged tissues or organs
		Engineered: Cells that have undergone substantial manipulation to achieve desired characteristics	For tissue repair or regeneration

ATMP: Advanced therapy medicinal product; GTMP: Gene therapy medicinal product; SCTMP: Somatic cell therapy medicinal product; TEP: Tissue-engineered product; CAR-T: Chimeric antigen receptor T.