Design and Investigation:~Dosage and mode of administration~First Dosage~125 million cells UC-MSCs to be injected~Procedure: Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with intralesional injection of an indicated dose of UC-MSCs~Second dosage~150 million cells UC-MSCs to be injected~Procedure: Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with intralesional injection of an indicated dose of UC-MSCs
The primary objective of this study is to demonstrate the safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) (product code: PF2020-CELL) administered by intralesional injection in patients with Crohn's fistula. The secondary objective is to compare the safety of a single/multiple UC-MSCs injection in a dose escalating manner as well as on the efficacy of stem cells treatment (reepithelialization of the external openings of fistula)