Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Phase 1 · Testing PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells · 1 site · CryoCord Sdn Bhd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (a biologic) as a possible treatment. Condition(s) listed: Perianal Fistula Due to Crohn's Disease and Fistula in Ano.
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 5 participants are expected to take part.
- Start date: 2022-03-01.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Malaysia.
Main thing being measured
- No incidence of treatment-emergent adverse events (TEAEs) (Throughout study completion, an average of 1.5 year)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Perianal Fistula Due to Crohn's Disease; Fistula in Ano |
| Lead sponsor | CryoCord Sdn Bhd |
| Collaborators | University of Malaya |
| Enrollment | 5 (estimated) |
| Start date | 2022-03-01 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2021-09-09 |
| Last updated | 2025-05-11 |
| 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 |
| ClinicalTrials.gov ID | NCT05039411 |
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.
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Malaya Medical Centre | Kuala Lumpur | Malaysia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.