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
- 2 February 2023
- journal article
- research article
- Published by Wiley in Journal of Gastroenterology and Hepatology
- Vol. 38 (4), 539-547
- https://doi.org/10.1111/jgh.16110
Abstract
Background and AimA 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. MethodsPlacenta-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). ResultsAmong 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. ConclusionAdministration 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.Keywords
This publication has 38 references indexed in Scilit:
- Development and regulation of exosome‐based therapy productsWIREs Nanomedicine and Nanobiotechnology, 2016
- Exosome mediated communication within the tumor microenvironmentJournal of Controlled Release, 2015
- The cryptoglandular theory revisitedColorectal Disease, 2015
- Should We Consider Topical Silver Nitrate Irrigation as a Definitive Nonsurgical Treatment for Perianal Fistula?Diseases of the Colon & Rectum, 2014
- Human mesenchymal stem cells creating an immunosuppressive environment and promote breast cancer in miceScientific Reports, 2013
- Therapeutic Potential of Mesenchymal Stem Cells in Regenerative MedicineStem Cells International, 2013
- Mesenchymal stem cell therapy: Two steps forward, one step backTrends in Molecular Medicine, 2010
- Teratoma Formation by Human Embryonic Stem Cells Is Site Dependent and Enhanced by the Presence of MatrigelStem Cells and Development, 2009
- Expanded Adipose-Derived Stem Cells for the Treatment of Complex Perianal FistulaDiseases of the Colon & Rectum, 2009
- Mesenchymal Stem Cell Therapy for Protection and Repair of Injured Vital OrgansCellular and Molecular Bioengineering, 2008