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Hemostemix - Model ACP-01 - Phase II Clinical Trial
FromHemostemix Inc.
Hemostemix is currently conducting a randomized, double-blind, placebo-controlled Phase 2 clinical trial for patients with critical limb ischemia at sites in the Canada and United States.
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- Diagnosed with CLI
- No treatment options
- Controlled levels in blood sugar, blood pressure, cholesterol
- No previous amputations above the ankle on target limb
- adverse events
- treatment failure
- pain
- quality of life
Clinical endpoints, as defined by treatment failure, are major amputation (above the talus, 2x wound size, de novo gangrene
Critical limb ischemia (CLI) is a chronic condition and is the most severe and deadliest form of peripheral arterial disease (PAD) with limited treatment options and no current approved drug treatments. CLI is characterized by insufficient blood supply to lower limbs. Complications include leg and foot ulcers which can lead to gangrene and limb loss due to amputation. CLI has a high rate of amputation and mortality.