Mesenchymal stem cells-derived exosomes in severe refractory inflammatory bowel disease patients

Safety and efficacy of placental mesenchymal stem cells-derived exosomes in severe refractory inflammatory bowel disease patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230801058996N5

Enrollment

Registered

2024-06-22

Start date

2024-07-22

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Ulcerative colitis. Condition 2: Crohn's disease. Ulcerative colitis Crohn disease

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Ulcerative colitis and/or Crohn's disease for at least 6 months with refractory, or intolerance, or contraindication to use with monoclonal antibodies Highly active Crohn's disease with a Crohn's disease index greater than 450 and/or a simple endoscopic score = 8 (or = 6 for isolated intestinal disease)

Exclusion criteria

Exclusion criteria: Using common immunomodulators in the past 4 weeks

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Evaluating the progress of the disease using the Crohn's disease activity index for Crohn's disease and Myoscore for ulcerative colitis, the 36-item questionnaire for improving the quality of life, measuring fecal calprotectin, CRP, short chain fatty acids, endoscopy and biochemical 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.	—

Measure

Time frame

Evaluating the progress of the disease using the Crohn's disease activity index for Crohn's disease and Myoscore for ulcerative colitis, the 36-item questionnaire for improving the quality of life, measuring fecal calprotectin, CRP, short chain fatty acids, endoscopy and biochemical 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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Roshandel

Shahid Beheshti University of Medical Sciences

elham.roshandel@gmail.com+98 21 2303 1658

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026