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
Who is this study for? Patients with Crohn's disease
What treatments are being studied? Human umbilical cord mesenchymal stem cells
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Malaysia
University of Malaya Medical Centre
RECRUITING
Kuala Lumpur
Contact Information
Primary
April Camilla Roslani, Prof. Dr.
april@ummc.edu.my
+603-7949 2050
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 5
Treatments
Experimental: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.
Related Therapeutic Areas
Sponsors
Collaborators: University of Malaya
Leads: CryoCord Sdn Bhd