Trial Details

Not Recruiting
Basic Information
Clinical ID c2065
Identifier IRCT20230801058996N5
Trial Title Safety and efficacy of placental mesenchymal stem cells-derived exosomes in severe refractory inflammatory bowel disease patients
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Intervention group: Injection of placental mesenchymal stem cells-derived exosomes: On day 1, 3 vials of exosomes (equivalent to 1011 particles or 250-300 micrograms of exosome) with an interval of 8 hours, then one vial of exosome maintenance dose daily on days 2, 3, 10 and 21 slowly ( 5 to 10 minutes) into the central vein.
Interventions The percentage of patients who show adverse effects during or after exosome injection. Timepoint: From the first dose of exosome infusion until 3 months on days 7, 30, 60 and 90 after the last dose. Method of measurement: Patient statements and medical team examinations in regular patient visits to the gastroenterology clinic for follow-up.;Response to treatment (based on clinical and laboratory tests). Timepoint: From the first dose of exosome infusion until 3 months on days 7, 30, 60 and 90 after the last dose. Method of measurement: Regular patient examination in gastroenterology clinic for follow-up.
Participant Information
Sponsor Shahid Beheshti University of Medical Sciences
City -
Country/Region Elham Roshandel
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -