Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Recruiting
Phase 1
Interventional Study
Perianal Fistula Due to Crohn's Disease
Fistula in Ano
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 5 (estimated)
- Sponsor
- CryoCord Sdn Bhd · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
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…
Contacts