Evaluation of safety and efficacy: a case series of chronic limb-threatening ischemia treated with endovascular revascularization and umbilical cord mesenchymal stem cell therapy

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R. Mohammad Reza Juniery Pasciolly, Suci Indriani, Muhammad Taufik Ismail, Novi Kurnianingsih, Januar Wibawa Martha, Ahmad Faried, Mas Rizky A. A. Syamsunarno, Fajar Awalia Yulianto, Arya Maheswara Wardhana, Nurvita Trianasari, Osamu Iida

2025 Stem Cell Research and Therapy Vol. 16 Issue 1 Review Cited by 0 Quartile

Abstract

Background: Severe chronic limb-threatening ischemia has significant challenges, leading to poor outcomes, including amputation and death. By guiding angiosome blood flow to the ulcerated foot, a therapeutic combination of endovascular revascularization and mesenchymal stem cells can achieve a good outcome. Objective: To describe the efficacy and safety of combination endovascular treatment and umbilical cord mesenchymal stem cell (UCMSC) treatment for chronic limb threatening ischemia. Methods: The design of the study was a longitudinal study, serial case report and prospectively observed pilot study. All patients received intramuscular UCMSC with a dosage of 1–2 million cells per kilogram of body weight then followed by endovascular intervention based on angiosome guided. We monitored the patients efficacy and safety for 12, 18, and 24 months. Result: This study involved six patients. All patients have an ankle brachial index below 0.4, and 83.3% of patients have diabetes mellitus, high creatinine level with an average of 1.64 mg/dl, and severe pain scores based on the Visual Analog Scale (VAS) of more than 7. 6th month was the time where the creatinine median was reduced, the ABI median was increased, the wound improvement started to happen. While the pain median score was reaching zero in 12 months of observation. 24 months revealed significant improvements in patient outcomes across pain scores, creatinine levels, and ankle-brachial index (ABI) with p < 0.05. Conclusion: The new technique, unique and innovative research, for using combination treatment of intramuscular UCMSC and modern endovascular procedures based on angiosome concept showed fast and safe wound healing, reduce rest leg pain, and increase ABI. © The Author(s) 2025.

Affiliations

Faculty of Medicine, Bandung Islamic University, Bandung, Indonesia; Department of Cardiology and Vascular Medicine, Welas Asih (Al Ihsan) General Hospital, West Java, Bandung, Indonesia; Department of Cardiology and Vascular Medicine, Faculty of Medicine, Indonesia University, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Department of Cardiology and Vascular Medicine, Faculty of Medicine, Public Health, and Nursing (FK-KMK), Gadjah Mada University, Dr. Sardjito General Hospital, Yogyakarta, Indonesia; Department of Cardiology and Vascular Medicine, Faculty of Medicine, Brawijaya University, Dr Saiful Anwar General Hospital, Yogyakarta, Indonesia; Faculty of Medicine, Padjadjaran of University, Bandung, Indonesia; Hasan Sadikin General Hospital, Bandung, Indonesia; Padjadjaran University Hospital, Bandung, Indonesia; School of Economics and Business, Telkom University, Bandung, Indonesia; Osaka Keisatsu Hospital Cardiovascular Division, Osaka International Medical & Science Center, Osaka, Japan