Assessment of the effect of allogeneic adipose derived mesenchymal stem cells along with platelet rich fibrin for perianal fistulas in treatment of perianal fistulas

Phase 1

Conditions: perianal fistula.
Fistula, other specified site
M25.18

Registration Number: IRCT20210830052332N1

Lead Sponsor: Iranian academic center for education culture and research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 24

Inclusion Criteria

Complex anal fistula recurrent fistula, high trans sphincteric fistula, supra sphincteric fistula, extra sphincteric fistula, and horseshoe fistula
patient who is older than 18 years of age
Patients who can sign informed consent

Exclusion Criteria

Patients with Crohn's disease, HIV, BCG and hepatitis
Significant Medical Comorbidity such as Active Cardiac Angina Uncontrolled Diabetes Mellitus and Active Collagen Vascular Disease Renal and Hepatic Failure
Pregnancy or breastfeeding
Neoplasia or anorectal cancer
Alcohol and drug addiction
Undischarged perianal fistula
Patients taking immunosuppressive drugs
Bone Marrow Dysfunction

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Efficacy and Safety allogeneic adipose derived mesenchymal stem cells along with platelet-rich fibrin for perianal fistula. Timepoint: One month and six months. Method of measurement: The clinical examination will be performed repeatedly by a specialist surgeon at intervals of the third day, the tenth day, the first month, the third month, and the sixth month. MRI evaluation will also be done in the sixth month. In addition, the length of hospital stay, infections, any other serious complications, and bleeding and their survival will be recorded. It should be noted that at time points of one month and six months after injection, in addition to reporting the results of the above parameters, CRP levels will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Wound healing. Timepoint: Six month. Method of measurement: Accurate measurement using digital calipers with an accuracy of one hundredth of a millimeter.;Infection improvement in the wound area. Timepoint: Six month. Method of measurement: Examination of the wound site and history.