Gene and Advanced Cell Therapies

Gene and advanced cell therapies are medicines built from genes, substantially manipulated cells or engineered tissue, regulated more tightly than any other orthobiologic.

They are the most heavily regulated interventions a sport and exercise medicine (SEM) clinician is likely to be asked about, and they have transformed care in a small number of serious conditions. In musculoskeletal practice their established role is narrow, and they are often misrepresented in marketing.

The clinician needs 3 things: what these therapies are and how they differ from other orthobiologics, how they are regulated as advanced therapy medicinal products (ATMPs), and how they meet anti-doping rules, since gene and cell doping is a prohibited method in its own right.