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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Perianal Fistula Due to Crohn's Disease Fistula in Ano

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No