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

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.