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RECRUITING
NCT05039411
PHASE1

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease

Sponsor: CryoCord Sdn Bhd

View on ClinicalTrials.gov

Summary

Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).

Official title: A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2022-03-01

Completion Date

2026-12-31

Last Updated

2025-05-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells

All patients will receive a total of 60 million PF2020-CELL (UC-MSCs) cells per treatment visit.

Locations (1)

University of Malaya Medical Centre

Kuala Lumpur, Malaysia