Crohn Patients with fistula. Crohn's disease of small intestine with fistula
Conditions
Interventions
In a single-arm clinical trial, 6 patients with Crohn disease with perianal fistula are enrolled according to inclusion criteria
after the patients written consent, the patient will receive a dose of mesenchymal derived stem cell exosome ( extracted the same protocol used in previous studies), the exosome will be injected in th
Sponsors
Omid cell and tissue Company
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The size of fistula tract. Timepoint: Investigating the fistula healing after 3 and 6 month after injection. Method of measurement: MRI imaging. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactseyed Mohsen Ahmadi Tafti
Tehran University of Medical Sciences
Outcome results
None listed