Critical Limb Ischemia

Disease Profile

Critical limb ischemia (CLI) is characterized by chronic, inadequate blood flow to limbs, resulting in tissue loss and gangrene¹·². Currently, no treatment exists for the most critical patients.

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)


ACP-01 Phase 2 Clinical Trial

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 South Africa.

33 control

66 treated

Target Patients

  • Diagnosed with CLI
  • No treatment options
  • Controlled levels in blood sugar, blood pressure, cholesterol
  • No previous amputations above the ankle on target limb

Data collection





of life


¹Clinical endpoints, as defined by treatment failure, are major amputation (above the talus, 2x wound size, de novo gangrene

How to Participate
in the ACP-01 Clinical Trial

For information about participating in the clinical trial please contact

Christy Pifer
Clinical Trial Manager