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

RecruitingPhase 1Ages 18 Years - anyAllCryoCord Sdn Bhd
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
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).
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What it tests

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

1 site
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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