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.
ACP-01 for Critical Limb Ischemia
ACP-01, Hemostemix’s lead clinical candidate, is an autologous cell therapy to treat critical limb ischemia (CLI) in patients who are facing amputation.
ACP-01 consists of cells that are derived from the patient’s blood and are modified with Hemostemix’s technology that primes them to form new blood vessels. These cells, known as angiogenic cell precursors, or ACPs, secrete growth factors and cytokines that support the formation of blood vessels through vasculogenesis and angiogenesis.
Factors secreted by ACPs also facilitate the recruitment of additional progenitor cells to promote the healing of damaged tissues. When these cells are injected into the dying leg muscle of the same patient with critical limb ischemia, they support the regeneration of new small blood vessels and may prevent amputations.
ACP-01 has been administered in several clinical studies with encouraging results:
- Severe Angina Pectoris – Bangkok (24 patients)
- Critical Limb Ischemia – Safety trial: Bangkok (6 patients)
- Critical Limb Ischemia – Phase 1b controlled: Budapest (10 treated, 10 control patients)