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Clinical Trial Summary

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)


Clinical Trial Description

Design and Investigation: Dosage and mode of administration 1. 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 2. 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05039411
Study type Interventional
Source CryoCord Sdn Bhd
Contact April Camilla Roslani, Prof. Dr.
Phone +603-7949 2050
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date January 1, 2022
Completion date December 31, 2023

See also
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