Lower limb ischemia

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    About Treatment

    Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is characterized by pain at rest and non-healing ulcers in the lower extremities. For patients with CLI, where the extent of atherosclerotic artery occlusion is too severe for surgical bypass or percutaneous interventions, limb amputation remains the only treatment option. Thus, cell-based therapy to restore perfusion and promote wound healing in patients with CLI is under intense investigation. Despite promising preclinical studies in animal models, transplantation of bone marrow (BM)-derived cell populations in patients with CLI has shown limited benefit preventing limb amputation. Early trials injected heterogenous mononuclear cells containing a low frequency of cells with pro-vascular regenerative functions. Most trials transferred autologous cells damaged by chronic disease that demonstrated poor survival in the ischemic environment and impaired function conferred by atherosclerotic or diabetic co-morbidities. Finally, recent preclinical studies suggest optimized blood vessel formation may require paracrine and/or structural contributions from multiple progenitor cell lineages, angiocrine-secretory myeloid cells derived from hematopoietic progenitor cells, tubule-forming endothelial cells generated by circulating or vessel-resident endothelial precursors, and vessel-stabilizing perivascular cells derived from mesenchymal stem cells. Understanding how stem cells co-ordinate the myriad of cells and signals required for stable revascularization remains the key to translating the potential of stem cells into curative therapies for CLI. Thus, combination delivery of multiple cell types within supportive bioengineered matricies may represent a new direction to improve cell therapy strategies for CLI.


    Improvements that can be expected after stem cell therapy:

    Stop worrying pain in the legs.

    “Intermittent claudication” disappears

    Sleep normalizes

    There is an opportunity to lead a familiar lifestyle.

    Consultation from a doctor for free

    Get advice from a leading specialist and find out how stem cells will help you.


    Autologous Stem Cell Therapy in Critical Limb Ischemia: A Meta-Analysis of Randomized Controlled Trials


    Critical limb ischemia (CLI) is the most dangerous stage of peripheral artery disease (PAD) caused by distal tissue hypoxia injury and lack of blood supply, including distal extremity ischemia, ulcers, or gangrene [12]. The prevalence of PAD in the general population is 3% to 10% [34]. The data showed that 11.2% of patients with PAD would deteriorate to CLI each year, and the patient with CLI had the high amputation and mortality rates [5]. Currently, patients in PAD could be treated by percutaneous transluminal angioplasty (PTA) or intravascular thrombolysis [67]; however, 10%–30% of patients with CLI are not candidates for revascularization surgery. Many patients lose the chance of PTA, and the prognosis is poor after surgery, because the patients have peripheral atherosclerosis obliterans, extensive vascular disease, and/or serious damage caused by severe ischemic lesions of limbs [89]. The studies [310] found that vascular remodeling and other means still cannot alleviate the symptoms of ischemia. The amputation rate is 10%–40%, and the mortality rate is up to 20% in patients with CLI within 6 months [11]. The angiogenesis is the optimal treatment for CLI, and autologous stem cell therapy is an emerging alternative treatment [1213].

    Efficacy and Safety of Autologous Cell-based Therapy in Patients With No-option Critical Limb Ischaemia: A Meta-Analysis


    Revascularisation therapy is the current gold standard of care for critical limb ischemia (CLI), although a significant proportion of patients with CLI either are not fit for or do not respond well to this procedure. Recently, novel angiogenic therapies such as the use of autologous cellbased therapy (CBT) have been examined, but the results of individual trials were inconsistent.

    Implantation of autologous CBT may be an effective therapeutic strategy for no-option CLI patients. BM-MNC and m-PSBC appear more effective than NCT in improving AR and other limb perfusion parameters. BM-MSC may be beneficial in improving perfusion parameters but not AR, however, this observation needs to be confirmed in a larger population of patients. Generally, treatment using various sources and phenotypes of cell products appeared safe and well tolerated. Large-size RCTs with long follow-up are warranted to determine the superiority and durability of angiogenic potential of a particular CBT and the optimal treatment regimen for CLI.