Functional and Clinical Outcomes of Autologous Bone Marrow and Umbilical Fat Stem Cells in the Treatment of Critical Limb Ischemia

Objectives Critical limb ischemia (CLI) represents the most advanced stage of peripheral arterial disease and is associated with high morbidity, limb loss, and limited therapeutic options in patients who are not eligible for revascularization. This study aimed to investigate the long-term clinical and functional effects of intrathecal administration of a combined autologous stromal vascular fraction (SVF) and bone marrow–derived mononuclear cell (BMAC) therapy in patients with no-option CLI. Materials and methods This prospective interventional case series included 20 patients with CLI who were unsuitable for surgical or endovascular revascularization. Autologous SVF obtained from umbilical adipose tissue and BMAC harvested from the posterior iliac crest were mechanically processed, combined under sterile conditions, and administered intrathecally via lumbar puncture. Clinical and functional outcomes were evaluated at baseline and at 3, 6, 9, and 12 months following treatment. Outcome measures included ankle–brachial index (ABI), pain intensity assessed by the Visual Analog Scale (VAS), and pain-free walking distance measured using a standardized six-minute walking test. Results Intrathecal SVF + BMAC therapy was well tolerated, with no serious neurological or systemic adverse events observed during follow-up. ABI values demonstrated a significant improvement at 9 and 12 months compared with baseline (p < 0.05), indicating enhanced peripheral perfusion. Pain scores showed no significant change in the early follow-up period; however, significant reductions were observed at 9 and 12 months (p < 0.05). Similarly, pain-free walking distance increased modestly during the first 6 months and showed significant improvement in the late follow-up period (p < 0.05), reflecting progressive functional recovery. Conclusion Intrathecal administration of combined autologous SVF and BMAC may represent a novel and feasible therapeutic approach for patients with no-option CLI, leading to delayed but sustained improvements in peripheral circulation, pain relief, and functional capacity. These findings suggest a potential role for central neurovascular and paracrine mechanisms in mediating peripheral vascular recovery. Larger, controlled studies are warranted to further elucidate the efficacy, safety, and underlying mechanisms of this exploratory treatment strategy.