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

Sponsor

CryoCord Sdn Bhd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05039411

Collaborator

University of Malaya (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to demonstrate the safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) (product code: PF2020-CELL) administered by intralesional injection in patients with Crohn's fistula. The secondary objective is to compare the safety of a single/multiple UC-MSCs injection in a dose escalating manner as well as on the efficacy of stem cells treatment (reepithelialization of the external openings of fistula)

Condition or Disease	Intervention/Treatment	Phase
Perianal Fistula Due to Crohn's Disease Fistula in Ano	Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs)	Phase 1

Detailed Description

Design and Investigation:

Dosage and mode of administration

First Dosage

125 million cells UC-MSCs to be injected
Procedure: Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with intralesional injection of an indicated dose of UC-MSCs

Second dosage

150 million cells UC-MSCs to be injected
Procedure: Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with intralesional injection of an indicated dose of UC-MSCs

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

First dose is125 million cells and only proceed to second dose of 150 million cells for patients clinically not recovered after 24 weeks from first dose.First dose is125 million cells and only proceed to second dose of 150 million cells for patients clinically not recovered after 24 weeks from first dose.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Human umbilical cord mesenchymal stem cells (UC-MSCs) All patients to receive allogeneic UC-MSCs via intralesional injection	Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs) All patients to receive 1st dose of 125 million UC-MSCs and the 2nd dose of 150 million UC-MSCs only if patients have no clinical improvement post 24 weeks after 1st dose

Arm

Intervention/Treatment

Experimental: Human umbilical cord mesenchymal stem cells (UC-MSCs)

All patients to receive allogeneic UC-MSCs via intralesional injection

Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs)

All patients to receive 1st dose of 125 million UC-MSCs and the 2nd dose of 150 million UC-MSCs only if patients have no clinical improvement post 24 weeks after 1st dose

Outcome Measures

Primary Outcome Measures

Incidence of any treatment-emergent adverse events (TE-AEs) [24 weeks]
Any composite of perianal sepsis, persistence of the fistula and allergic reaction.

Secondary Outcome Measures

Clinical healing [24 and/or 48 weeks]
Mainly on re-epithelialization of external opening

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).