RecruitingPhase 1NCT05039411

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

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


Sponsor

CryoCord Sdn Bhd

Enrollment

5 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety of stem cell therapy using cells from umbilical cord donors to treat complex anal fistulas — abnormal tunnels between the inside of the bowel and the skin around the anus — in patients with Crohn's disease who have not responded to medications. **You may be eligible if...** - You are 18 or older - You have Crohn's disease with anal fistulas that have not responded to medical treatment - You have no more than 2 internal and 3 external fistula openings - You are well enough to undergo surgery **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active cancer or were in remission from cancer less than 5 years ago - You have active sepsis or a significant local infection - You have HIV, hepatitis B or C, or syphilis - You have known severe allergies - You have received certain biologic drugs (like infliximab) in the past 4 weeks - You have been in another clinical trial in the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPF2020-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.


Locations(1)

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

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NCT05039411


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