CLTI is a growing major global health problem.

Chronic limb-threatening ischemia (CLTI), formerly known as critical limb ischemia (CLI), is a chronic condition and the most serious form of peripheral arterial disease (PAD). It is a growing major global health problem that already affects 1–1.5% of the population aged over 40 in North America, Europe, and Asia.

Diabetes significantly increases the risk of both PAD and CLTI, with 5.8% of diabetic patients over 50 years old having CLTI. The threat of CLTI is growing due to our ageing populations and the increasing incidence of diabetes.

Complications have a serious impact on quality of life.

CLTI results from a severe blockage of the arteries in the lower leg. Symptoms include severe burning pain in the feet or toes, particularly at rest. Complications include non-healing ulcers in the legs and feet that commonly lead to gangrene, with amputation of the affected limb often the only treatment option.

The amputation rate within a year of diagnosis is estimated at 25%, but varies according to the severity of the condition, with rates of 11% in patients with superficial ulcers, and up to 83% in patients with gangrene. In addition to limb loss, CLTI is associated with a high risk of cardiovascular events, including heart attack, stroke and death. The annual mortality risk is as high as 20-25% with over 50% mortality within 5 years.

Current treatment options for CLTI are limited

Up to 60% of CLTI patients are eligible for surgical revascularization either by radiographic angiography or peripheral artery bypass graft. Of these patients, up to 60% respond to treatment.

The remaining 40% of patients are ineligible for revascularization. In addition, one third of patients do not respond to treatment and therefore approximately 60% of patients are very poorly treated. Options for these patients are limited to symptomatic treatment of pain and ulcers. For a significant proportion, major or minor amputation will be required to address complications of deep ulcers and gangrene or to address chronic pain, which does not respond to pain-relieving drugs. The likelihood of amputation increases according to the severity of the disease.

Given the severity of the condition and the limitations of current therapy, there is an urgent need for effective new treatments.

Click here to learn about REX-001, our multi-cell cell therapy for CLTI.

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