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IRCT20200413047063N3 IRCT 2021-09-03 Omid cell and tissue Company Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients 2021-07-31 anticipated 20 Complete https://irct.ir/trial/58155 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Crohn Patients with fistula. 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 the tract of the fistula weekly for three weeks, and the patients will be monitored closely for adverse and allergic reactions for 3months.. Yes - There is a plan to make this available What will be shared: Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients When: late 2021 To whom: scientific community including medical society and stem cell researchers Conditions: the criteria mentioned in this request Where to obtain: direct email How to obtain: one-three week period Comments:
public seyed Mohsen Ahmadi Tafti
Keshavars boluvard
tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 2997 smahmadit@sina.tums.ac.ir Tehran University of Medical Sciences scientific Masoud Soleimani
Jalal - al- Ahmad-Chamran High way
Tehran Iran (Islamic Republic of) 1415533122 +98 21 8288 0000 soleim_m@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iran (Islamic Republic of) 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 no limit no limit Both 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 K50.013 Crohn's disease of small intestine with fistula Treatment - Drugs 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 the tract of the fistula weekly for three weeks, and the patients will be monitored closely for adverse and allergic reactions for 3months. The size of fistula tract. Timepoint: Investigating the fistula healing after 3 and 6 month after injection. Method of measurement: MRI imaging. Omid cell and tissue Company Approved 2021-08-04 Iman Khomeini Hospital Complex Committee for Ethics in Biomedical Research- Tehran University of Med Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)