TH-SC01

TH-SC01 is an investigational allogeneic, umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy developed by TopCel-KH Biopharmaceutical (Jiangsu Tuohong Kangheng Pharmaceutical). It is an "off-the-shelf" cellular product manufactured under Good Manufacturing Practice (GMP) conditions. The therapy is primarily indicated for the treatment of complex, treatment-refractory perianal fistulas in patients with Crohn's disease (pfCD), as well as complex cryptoglandular anal fistulas and chronic radiation proctitis. TH-SC01 exerts its therapeutic effects through immunomodulatory and anti-inflammatory mechanisms, secreting bioactive molecules that regulate the local immune response and promote epithelial healing. It is typically administered via local intralesional injection into the tissues surrounding the fistula tracts and internal openings. Clinical development has reached Phase 3 for Crohn's-related perianal fistulas.

Other names

allogeneic umbilical cord-derived mesenchymal stem cellshuman umbilical cord-derived mesenchymal stem cellsUC-MSCs