Abstract
(1) Background: The treatment of peripheral arterial disease (PAD) is focused on improving perfusion and oxygenation in the affected limb. Standard revascularization methods include bypass surgery, endovascular interventional procedures, or hybrid revascularization. Cell-based therapy can be an alternative strategy for patients with no-option critical limb ischemia who are not eligible for endovascular or surgical procedures. (2) Aims: The aim of this narrative review was to provide an up-to-date critical overview of the knowledge and evidence-based medicine data on the position of cell therapy in the treatment of PAD. The current evidence on the cell-based therapy is summarized and future perspectives outlined, emphasizing the potential of exosomal cell-free approaches in patients with critical limb ischemia. (3) Methods: Cochrane and PubMed databases were searched for keywords “critical limb ischemia and cell therapy”. In total, 589 papers were identified, 11 of which were reviews and 11 were meta-analyses. These were used as the primary source of information, using cross-referencing for identification of additional papers. (4) Results: Meta-analyses focusing on cell therapy in PAD treatment confirm significantly greater odds of limb salvage in the first year after the cell therapy administration. Reported odds ratio estimates of preventing amputation being mostly in the region 1.6–3, although with a prolonged observation period, it seems that the odds ratio can grow even further. The odds of wound healing were at least two times higher when compared with the standard conservative therapy. Secondary endpoints of the available meta-analyses are also included in this review. Improvement of perfusion and oxygenation parameters in the affected limb, pain regression, and claudication interval prolongation are discussed. (5) Conclusions: The available evidence-based medicine data show that this technique is safe, associated with minimum complications or adverse events, and effective.
Highlights
Most regulatory authorities have realized the need for early access to innovative therapies for unmet medical needs that may improve health care quality for life-threatening conditions
(5) Conclusions: The available evidence-based medicine data show that this technique is safe, associated with minimum complications or adverse events, and effective
Critical limb ischemia (CLI) is the end-stage of peripheral artery disease (PAD) caused by tissue hypoxia and characterized by ischemic rest pain, ulcers, or gangrene associated with a significant risk of affected limb loss and a high risk for cardiovascular events
Summary
Most regulatory authorities have realized the need for early access to innovative therapies for unmet medical needs that may improve health care quality for life-threatening conditions. Since critical limb ischemia is a significant healthcare problem with its rising incidence, accelerating the development of innovative advanced therapies is essential. Cell therapy’s therapeutic efficacy in various animal models has been only partially reproduced in human clinical trials. Despite the progress in basic and clinical research over the last two decades, the regenerative therapy of limb ischemia based on cell therapy is still considered an experimental treatment method, not recommended for routine clinical use
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