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

Last updated: May 7, 2025
Sponsor: CryoCord Sdn Bhd
Overall Status: Active - Recruiting

Phase

1

Condition

Rectal Disorders

Treatment

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

Human umbilical cord mesenchymal stem cells (UC-MSCs)

Clinical Study ID

NCT05039411
CCSB-CT-PF-01-2021 (Ver4.0)
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult men and women age 18 years and above.

  • Diagnosis of perianal fistulae associated with Crohn's disease refractory to medicaltherapy.

  • Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximumof 3 external openings based on clinical assessment.

  • Fit for surgery.

Exclusion

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 beforethe cell treatment administration.

  • Patients currently receiving, or having received within 1 month prior to enrollmentinto this clinical trial, any investigational drug.

  • Patients with any other co-morbidity/ co-pathologies which is deemed ascontraindication to stem cells infusion (infection, administration of steroids).

Study Design

Total Participants: 5
Treatment Group(s): 2
Primary Treatment: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
Phase: 1
Study Start date:
March 01, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

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