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Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Perianal Fistula in Non-Crohn's Cases: Clinical Trial Phase I Publisher Pubmed



Pak H1, 2 ; Hadizadeh A2 ; Heiranitabasi A1, 2 ; Soleimani M3 ; Asbagh RA1 ; Fazeli MS1, 4 ; Kazemeini A1, 4 ; Keshvari A1, 4 ; Keramati MR1, 4 ; Salahshour F5 ; Nazari H6 ; Tafti SMA1, 4 ; Behboudi B1, 4
Authors
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Authors Affiliations
  1. 1. Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Research Center for Advanced Technologies in Cardiovascular Medicine, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Cell Therapy and Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
  4. 4. Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Department of Radiology, Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Department of radiology, Isfahan university of medical sciences, Isfahan, Iran

Source: Journal of Gastroenterology and Hepatology (Australia) Published:2023


Abstract

Background and Aim: A perianal fistula is an abnormal tract that connects anal canal to skin. Current medical and surgical interventions have a high failure rate particularly in complex and refractory cases. MSC-derived exosomes have demonstrated immunomodulatory effects without the conventional complications; hence, in this study, we evaluated the safety of their application for complex perianal fistula. Methods: Placenta-derived MSCs were cultured, and exosomes were isolated using ultracentrifugation. Exosome injections were administered in the operating room to 11 patients with complex perianal fistula (presence of fistulas for at least 1 year alongside medical and surgical treatment). The patients were followed for 6 months, and the patients were evaluated using physical examination, face-to-face interviews, and magnetic resonance imaging (MRI). Results: Among 11 patients only one did not show any improvement upon physical examination. Five patients showed complete tract resolve. While the discharge was stopped in eight patients, two patients showed only reduction. None of the patients showed any acute or latent allergic reaction or injection related complications. Conclusion: Administration of exosomes isolated from MSCs demonstrates safety and a satisfactory therapeutic effect in treatment complex perianal fistulae; therefore, it can be a candidate for future studies and might play a significant role in treatment. © 2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
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