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IRCT20210830052332N1 IRCT 2022-04-05 Iranian academic center for education culture and research 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 2022-08-30 anticipated 24 Complete https://irct.ir/trial/58399 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 1-2 perianal fistula. 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 group 2: a group in which patients with anal fistula will be treated with platelet-rich fibrin along with conventional surgery. Intervention 3: Intervention group 3: a group in which patients with anal fistula will be treated with allogeneic mesenchymal stem cells with platelet-rich fibrin along with conventional surgery. Intervention 4: Control group: a group in which patients with anal fistula will be treated with conventional surgery. Yes - There is a plan to make this available What will be shared: The final report of the data will be given to the research deputy of Qom ACECR When: 6 months after publishing the results To whom: General surgeon and specialist fistula surgeon Conditions: All researchers are allowed to receive work protocols and data in accordance with the principles of professional ethics Where to obtain: Contact the author by email at mohsen.sh2009@gmail.com How to obtain: Contacting the author's email (mohsen.sh2009@gmail.com) takes about ten days. Comments:
public Hoda Fazaeli
The Academic Center for Education, Culture and Research, Qom Branch, Shabnam St, Isar Sq, Imam Khomeini Town (Bonyad), Department of Stem Cell, Qom, Iran
Qom Iran (Islamic Republic of) 3713189934 +98 25 3270 0152 hodafazaely@yahoo.com Iranian academic center for education culture and research scientific Mohsen Sheykhhasan
Department of Stem Cell, The Academic Center for Education, Culture and Research, Qom Branch, Shabnam St, Isar Sq, Imam Khomeini Town (Bonyad), Qom, Iran
Qom Iran (Islamic Republic of) 3713189934 +98 25 3270 0152 mohsen.sh2009@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) 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 19 years no limit Both 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 M25.18 Fistula, other specified site Treatment - Other Treatment - Other Treatment - Other Treatment - Surgery Intervention group 1: a group in which patients with anal fistula will be treated with allogeneic mesenchymal stem cells along with conventional surgery. Intervention group 2: a group in which patients with anal fistula will be treated with platelet-rich fibrin along with conventional surgery. Intervention group 3: a group in which patients with anal fistula will be treated with allogeneic mesenchymal stem cells with platelet-rich fibrin along with conventional surgery. Control group: a group in which patients with anal fistula will be treated with conventional surgery. 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. 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. Iranian academic center for education culture and research Approved 2021-08-10 Research Ethics committee of Mashhad Academic Center for Education, Culture and Research Academic center for education, culture and research (ACECR), Khorasan Razavi Province Branch, Azadi Sq, Daneshgah Campus, Khorasan Razavi province, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)