Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients

Phase 1

Recruiting

• Conditions: Crohn Patients with fistula.; Crohn's disease of small intestine with fistula; K50.013

• Registration Number: IRCT20200413047063N3
• Lead Sponsor: Omid cell and tissue Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with anti TNF, without any success
Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with infliximab, without any success
Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with infliximab and anti TNF, without any success
Patient with Crohn or other IBD disease, resistance to a 6 month period of drug therapy and surgery, without any success

Exclusion Criteria

Patients with immunodeficiency disorders/disease
Patients with history of malignancy
Patient dissatisfaction
Patients in need of surgery
Severe co-morbidities (e.g., renal failure, liver failure, etc.)
Cerebral Damage

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The size of fistula tract. Timepoint: Investigating the fistula healing after 3 and 6 month after injection. Method of measurement: MRI imaging.