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

Primary Purpose

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

Status

Recruiting

Phase

Phase 1

Locations

Malaysia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Perianal Fistula Due to Crohn's Disease focused on measuring Perianal fistula, Crohn's Disease, Umbilical cord mesenchymal stem cells (UC-MSCs), Allogeneic stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

University of Malaya Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Two million cells per milliliter (2M/mL) with 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 to receive allogeneic PF2020-CELL (UC-MSCs) via intralesional injection for 5 consecutive visits, with a 4-week 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.

Outcomes

Primary Outcome Measures

No incidence of treatment-emergent adverse events (TEAEs)

TEAEs in this study are defined as adverse events other than: pyrexia (non-persistent fever, <38.5°C), anal abscess, pain in the rectum/anus & procedural pain (pain after fistula cleaning).

Secondary Outcome Measures

Clinical healing

Mainly on re-epithelialization of external opening

Full Information

NCT ID

NCT05039411

First Posted

September 1, 2021

Last Updated

October 9, 2023

Sponsor

CryoCord Sdn Bhd

Collaborators

University of Malaya

1. Study Identification

Unique Protocol Identification Number

NCT05039411

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

January 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CryoCord Sdn Bhd

Collaborators

University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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: Two million cells per milliliter (2M/mL) with 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 consecutive visits, with a 4-week 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

All patients will receive a total of 60 million cells per visit for 5 consecutive visits, with a 4-week 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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

No incidence of treatment-emergent adverse events (TEAEs)

Description

TEAEs in this study are defined as adverse events other than: pyrexia (non-persistent fever, <38.5°C), anal abscess, pain in the rectum/anus & procedural pain (pain after fistula cleaning).

Time Frame

Throughout study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Clinical healing

Description

Mainly on re-epithelialization of external opening

Time Frame

Week 2, 6, 10, 14, 18, 20, 24, 32, 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

April Camilla Roslani, Prof. Dr.

Phone

+603-7949 2050

april@ummc.edu.my

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

April Camilla Roslani, Prof. Dr.

Organizational Affiliation

Faculty of Medicine, University of Malaya

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Malaya Medical Centre

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

April Camilla Roslani, Prof. Dr.

Phone

+603-7949 2050

april@ummc.edu.my

First Name & Middle Initial & Last Name & Degree

April Camilla Roslani, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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