Issues with Tissues: Trends in Tissue-Engineered Products in Clinical Trials in the European Union.

ABSTRACT: Tissue-engineered products (TEPs) consist of engineered cells or tissues produced to regenerate, repair, or replace a dysfunctional, diseased, or absent human tissue. TEPs make up <5% of all advanced therapeutic medicinal products (ATMPs) in clinical trials and received 5.1% of ATMP-designated funding in trials in the European Union (EU) in 2019, highlighting the relatively low proportion of TEPs being developed. The realization of TEPs being marketed has yet to be fulfilled, with few products being approved. Since 2009, 90 TEP-based clinical trials have been undertaken in the EU. Of these 90, 25 were Phase I/II trials, 35 were Phase II, 28 were Phase III, and two were Phase IV trials. This review provides an overview of TEPs in development, identifying musculoskeletal, cardiovascular, and

SUBMITTER: Joyce K 

PROVIDER: S-EPMC9940800 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature