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

NCT05039411 | Recruiting Phase 1 DMC

• 1 other identifier: CCSB-CT-PF-01-2021 (Ver4.0)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Perianal fistula; Crohn's Disease; Umbilical cord mesenchymal stem cells (UC-MSCs); Allogeneic stem cells

Outcome Measures

Primary Outcomes (1)

• No incidence of treatment-emergent adverse events (TEAEs)

  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 Outcomes (1)

• Clinical healing

  Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CryoCord Sdn Bhd: lead
• University of Malaya: collaborator

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Rectal Fistula; Crohn Disease

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis

Study Officials

• April Camilla Roslani, Prof. Dr.

  Department of Surgery, Faculty of Medicine, University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Camilla Roslani, Prof. Dr.

CONTACT

+603-7949 2050; april@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients will receive a total of 60 million cells per visit for 5 consecutive 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)