BACKGROUND AND OBJECTIVES: Half of patients with critical limb ischemia (CLI) are ineligible for revascularization at diagnosis. The aim of this study was to assess the safety and feasibility of intramuscular human umbilical cord blood-derived mesenchymal stem cell (hUCB-MSC) therapy in patients with CLI due to atherosclerosis obliterans (ASO) or thromboangiitis obliterans (TAO). METHODS AND RESULTS: A total of eight patients (all male, median age 52 years, range 31~77) with CLI were enrolled in this phase I trial. All patients were considered ineligible for further revascularization to improve CLI. We injected 1x10(7) hUCB-MSCs per single dose intramuscularly into the affected limb. The primary end points of safety were occurrence of adverse events (procedure-related complication, allergic reaction to hUCB-MSCs, graft-versus-host disease, cardiovascular and cerebrovascular events) and improvement of symptoms/clinical parameters (healing of foot ulcer, ankle-brachial index, and pain-free walking distance). Angiogenesis was measured with conventional angiography and scored by an independent reviewer. There were four adverse events in three patients. One patient, developed whole body urticaria after injection on treatment day, which disappeared after one day of antihistamine treatment. The other adverse events included diarrhea, oral ulceration, and elevation of serum creatinine level; all conditions improved without treatment. Abnormal results of laboratory parameters were not detected in any patients. Three of four ulcerations (75%) healed completely. Angiographic scores increased in three of eight patients. CONCLUSIONS: This phase I study demonstrates that intramuscular hUCB-MSC injection is a safe and well tolerated treatment for patients with end-stage CLI due to ASO and TAO.
Angiography ; Ankle Brachial Index ; Arterial Occlusive Diseases ; Atherosclerosis ; Creatinine ; Diarrhea ; Extremities ; Fetal Blood ; Foot Ulcer ; Graft vs Host Disease ; Humans ; Hypersensitivity ; Ischemia ; Male ; Mesenchymal Stromal Cells ; Oral Ulcer ; Oxalates ; Stem Cells ; Thromboangiitis Obliterans ; Troleandomycin ; Ulcer ; Umbilical Cord ; Urticaria ; Walking

Purpose: This study aimed to evaluate the utilization and outcomes of resuscitative endovascular balloon occlusion of the aorta (REBOA) in managing noncompressible torso hemorrhage (NCTH) among trauma patients in Korea. The evolution of REBOA and its impact on patient survival was investigated as well as predictors of mortality. Methods: This retrospective study included 234 post-REBOA patients from 5 leading regional trauma centers across Korea between 2016 and 2021. Primary outcomes were in-hospital mortality, and secondary outcomes were various clinical parameters regarding REBOA, overall treatment flow, and complications. For comparative analyses, patients were dichotomized into in-hospital non-survivors or survivors. Then, generalized additive and linear regression models were used to evaluate the trend of in-hospital mortality. Results: The overall in-hospital mortality was 65.4%. The survivors had a higher proportion of responders following REBOA (87.7% vs 62.7%, p < 0.001). Key variables influencing outcomes included total occlusion time, red blood cell transfusion volume within the first 24 hours, revised trauma score, and systolic blood pressure gap. These factors significantly correlated with mortality rates in multivariate logistic regression. Conclusion Over 6 years, survival rates for NCTH patients undergoing REBOA in Korea have shown improvement. Despite diverse REBOA protocols across institutions, the results underscore the need for continued research, standardized practices, and national quality control measures to further optimize patient outcome and establish more effective treatment protocols for NCTH.