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IRCT20211212053361N1 IRCT 2021-12-22 Tehran University of Medical Sciences Safety and efficacy of exosome Injection in perianal fistula Safety and efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2021-12-22 anticipated 15 Complete https://irct.ir/trial/60622 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Complex perianal fistula. Intervention group:. Yes - There is a plan to make this available What will be shared: Questionairs, Patient's data, MRI data, results, statistical analysis,Material and methods When: Just after article publication To whom: Academic researchers Conditions: using in metaanalysis Where to obtain: Person responsible for scientific inquires How to obtain: Communicate with corresponding author, E-mail adress: smahmadit@sina.tums.ac.ir Comments:
public Seyed Mohsen Ahmadi Tafti
Tohid Square, Imam Khomeini Hospital complex
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1657 smahmadit@sina.tums.ac.ir Tehran University of Medical Sciences scientific Seyed Mohsen Ahmadi Tafti
Tohid Square,Imam khomeini Hospital complex
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1657 smahmadit@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18-70 years old Complex perianal fistula Informed consent 18 years 70 years Both Active inflammatory bowel disease Synchronous perianalabcess Alcohol, narcotic and stimulant consumption Having active hepatitis B,C, HIV or TB Pregnancy and lactation Uncontrolled diabetes mellitus Evidence of surgical contraindication Psychological disorders and noncooperative pateint Treatment - Drugs Intervention group: Discharge amount. Timepoint: before and during and 12 weeks after the study. Method of measurement: due to pateint's history. External orifice reepithelialisation. Timepoint: before and 12 weeks after the study. Method of measurement: clinical examination and MRI. Inflammation and abcess larger than 2 cm. Timepoint: before and 12 weeks after the study. Method of measurement: MRI. Quality of life questionair score. Timepoint: before and 12 weeks after the study. Method of measurement: Quality of life questionair in perianal fistula patients. Tehran University of Medical Sciences Approved 2021-12-01 Biomedical Research Ethics Committee Tohid square, Imam Khomeini hospital complex Tehran Tehran Iran (Islamic Republic of)