Update on clinical trials evaluating the effect of biologic therapy in patients with critical limb ischemia.

Section of Vascular Surgery, Dartmouth-Hitchcock Lebanon Medical Center, Lebanon, NH 03756-0001, USA.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter (Impact Factor: 3.52). 05/2012; 56(1):264-6. DOI: 10.1016/j.jvs.2012.03.255
Source: PubMed

ABSTRACT Critical limb ischemia (CLI) represents the most severe degree of peripheral arterial disease and is associated with significant morbidity and mortality. In patients with CLI who do not have revascularization options, major amputation is required within 1 year in as many as 40% of patients. Biologic therapies, which include gene therapy and cellular therapy, offer the potential to promote wound healing and prevent amputation in patients who otherwise have poor options for revascularization. Several recent phase 2 trials have shown acceptable safety and suggest that these biological therapies have the potential to improve outcomes in patients with "no-option" CLI. Phase 3 trials are now in progress. This report summarizes the recent results of, and future plans for, gene and cellular therapy clinical trials in patients with CLI.

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    ABSTRACT: The primary goals of treatment for critical limb ischemia (CLI) are alleviation of ischemic rest pain, healing of arterial insufficiency ulcers, and improving quality of life. These goals are directed toward preventing limb loss and CLI-related mortality. Arterial revascularization serves as the foundation of a contemporary approach to promote amputation-free survival. Mounting evidence supports a wound-directed angiosome revascularization approach, increasingly achieved with endovascular techniques. Innovations in technology and wound-perfusion strategy have advanced patient care and are accelerating the pace of CLI treatment. The evolving angiosome revascularization approach has been augmented with a multidisciplinary wound care strategy that deserves particular emphasis. These state-of-the-art advances in CLI management are reported herein with considerations for the future treatment of CLI.
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