CX401

CX401 is an autologous cell therapy composed of expanded adipose-derived mesenchymal stem cells (eASCs). Developed by Cellerix (which later merged with TiGenix), the therapy was designed for the treatment of complex perianal fistulas, including those associated with Crohn's disease. The treatment process involves harvesting a patient's own adipose tissue, isolating the mesenchymal stem cells, and expanding them in a laboratory setting before injecting them into the tissue surrounding the fistula tract. These cells are intended to exert immunomodulatory and anti-inflammatory effects, facilitating the closure of the fistula and promoting tissue regeneration. While CX401 reached Phase III clinical development and received Orphan Drug Designation from the EMA, the program was eventually discontinued in favor of the allogeneic version, Cx601 (darvadstrocel), which offered a more scalable manufacturing process.

Brand names

Ontaril

Other names

autologous adipose-derived mesenchymal stromal cellsautologous adipose-derived stem cellseASCsexpanded autologous adipose-derived stem cells