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

NCT05039411 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-05-11

No results posted yet for this study

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).

Conditions

  • Perianal Fistula Due to Crohn's Disease
  • Fistula in Ano

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.

Sponsors & Collaborators

  • University of Malaya

    collaborator OTHER

  • CryoCord Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • April Camilla Roslani, Prof. Dr. · Department of Surgery, Faculty of Medicine, University of Malaya

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039411 on ClinicalTrials.gov