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

Assessment of Efficacy and Safety of the allogeneic adipose derived mesenchymal stem cells along with platelet rich fibrin in 24 patients with perianal fistulas: a phase 1 and 2 pilot randomized, single blinded trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210830052332N1

Enrollment

Registered

2022-04-05

Start date

2022-08-30

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perianal fistula. Fistula, other specified site

Interventions

Intervention 1: Intervention group 1: a group in which patients with anal fistula will be treated with allogeneic mesenchymal stem cells along with conventional surgery. Intervention 2: Intervention g

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoda Fazaeli

Iranian academic center for education culture and research

hodafazaely@yahoo.com+98 25 3270 0152

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026