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

Evaluation of possible side effects including redness, local sensitivity, pruritus, anaphylaxis, pain, fever, localized exfoliation, and efficacy of treatment after injection of adipose derived stem cells with platelet rich fibrin in patients

A phase 1 and 2 pilot clinical trial with a control group, single blinded and randomized on 12 patients. Block randomization method was used for randomization.

Patients with anal fistula who refer to Shahid Beheshti Hospital during the study will be included in the study if they are eligible.

Inclusion criteria 1. Complex anal fistula (recurrent fistula, High Trans Sphincteric fistula, Supra Sphincteric fistula, Extra Sphincteric fistula, and Horse Shoe fistula) 2. Patient over 18 years old 3. Patients who are able to give informed consent Exclusion criteria 1. Patients with Crohn's disease, HIV, BGC infectious disease, and hepatitis 2. Simultaneous onset of several medically significant diseases (multifactorial) (Significant Medical Comorbidity) like active cardiac angina with uncontrolled diabetes (Active Cardiac Angina Uncontrolled Diabetes Mellitus) and Active Collagen Vascular Disease Renal and Hepatic Failure 3. Pregnancy or breastfeeding 4. Neoplasia or anorectal cancer 5. Addiction to alcohol and drugs 6. Undischarged anal fistula 7. Patients taking immunosuppressive drugs 8. Bone Marrow Dysfunction

Control group. Patients with anal fistula treated by conventional surgical method. Intervention group. Patients with anal fistula will be treated with allogeneic MSCs with platelet-rich fibrin along with conventional surgery.

side effects, Wound healing and filling of the lesion after one month and six months of injection; No bleeding after one month and six months of injection; No swelling at the injection site

In this study, we will use the restricted randomization method of Block randomization type. The size of all blocks is equal and we will have quarter blocks "including 2 participants in the intervention group and 2 participants in the control group" in this two-group trial. The letter A will be assigned to the intervention group and the letter B to the control group, and in quarter blocks with the letters A and B, the six modes of AABB, ABAB, BBAA, BABA, BBAA, BAAB will be written on separate sheets and will be placed in an envelope. One of these sheets will be randomly brought out from the envelope, and the written composition on it will be noted and that sheet will be thrown back into the envelope. Since the sample size in this study is 12 patients, this operation will be repeated 3 times, and each time the written composition on each sheet will be written in the composition sequence of the previous sheet. Then, for each of the letters, a number from one to twelve will be assigned according to the arrangement of the written letters in the sequence, and each letter will be placed inside an envelope and the number of that letter will be written on the envelope. Each time a patient is selected based on the inclusion criteria, one of these envelopes will be opened based on the order written on the envelope and it will be specified that the patient should be placed in the intervention or control group.

In order to eliminate the bias caused by the patient's awareness of the type of received treatment and its possible effect on the research results, the study is performed as a single blinded trial. Given that surgery is one of the therapeutic commonalities in both groups, it is natural that the patients are not aware of the injection of mesenchymal stem cells with platelet rich fibrin.

The final report of the data will be given to the research deputy of Qom ACECR

6 months after publishing the results

General surgeon and specialist fistula surgeon

All researchers are allowed to receive work protocols and data in accordance with the principles of professional ethics

Contact the author by email at mohsen.sh2009@gmail.com

Contacting the author's email (mohsen.sh2009@gmail.com) takes about ten days.