BridgeMD
Tests treatment safety and results for Perianal Fistula Due to Crohn's Disease
Official title Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
ClinicalTrials.gov ID: NCT05039411
What this study is testing
What is PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells?
PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for perianal fistula due to crohn's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.