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

May 7, 2025 updated by: CryoCord Sdn Bhd

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Design and Investigation:

Number of Patients: 5 (including a consideration of 20% [1 patient] dropout from the trial)

Dosage and mode of administration Dosage: A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.

Mode of administration: The procedure involves localizing the fistulous tract, performing curettage and closing the internal opening, and the injection of PF2020-CELL (UC-MSCs). The indicated dose of PF2020-CELL (UC-MSCs) will be injected starting from the tissues around the internal orifice or orifices and then progressing towards the external opening.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: April Camilla Roslani, Prof. Dr.
  • Phone Number: +603-7949 2050
  • Email: april@ummc.edu.my

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University of Malaya Medical Centre
        • Contact:
          • April Camilla Roslani, Prof. Dr.
          • Phone Number: +603-7949 2050
          • Email: april@ummc.edu.my
        • Principal Investigator:
          • April Camilla Roslani, Prof. Dr.
        • Sub-Investigator:
          • Ida Normiha Hilmi, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult men and women age 18 years and above.
  • Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy.
  • Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.
  • Fit for surgery.

Exclusion Criteria:

  • Informed consent refusal.
  • Pregnancy or breastfeeding women.
  • Current diagnosis of active cancer or remission for less than 5 years.
  • Evidence of active sepsis or significant localised infection.
  • Patients with HIV, HBV, HCV or treponema infection, whether active or latent.
  • Patients with documented allergies.
  • Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration.
  • Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
  • Patients with any other co-morbidity/ co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Throughout study completion, an average of 1.5 year
example of TEAEs are pyrexia (non-persistent fever, <38.5°C), infection, perianal abscess, enlargement of fistula & allergic reaction.
Throughout study completion, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical healing
Time Frame: Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits)
Mainly on re-epithelialization of external opening
Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CryoCord Sdn Bhd

Collaborators

University of Malaya

Investigators

  • Principal Investigator: April Camilla Roslani, Prof. Dr., Department of Surgery, Faculty of Medicine, University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCSB-CT-PF-01-2021 (Ver4.0)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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