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Peripheral Arterial Disease and Chronic Limb Threatening Ischemia: Prevent Lower Limb Amputation

Reduces ulcers, wounds and pain associated with peripheral arterial disease.

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Limb Treatments

Peripheral Arterial Disease (PAD) Symptoms

Cold, pale, or bluish feet, weak or absent pulse in the legs, muscle atrophy.

Rest Pain

Persistent or reoccurring pain (claudication) in the foot, toes, or leg, that is typically worse at night effecting sleep.

Non-Healing Ulcers

Open sores or wounds on the toe, foot or lower leg that fail to heal.

Gangrene

Tissue death (necrosis) on the toe, or foot, often appearing black, dry, or infected.

Symptoms

Test Results

Dry wound involving the distal tip of D1 immediately prior to treatment.
The wound healed four weeks after treatment with no evidence of recurrence.
Four months post treatment showing significant improvement. Concurrent treatment wearing an offloading orthotic and regular dressing changes.
4 months post treatment showing significant improvement. Concurrent treatment wearing an offloading orthotic and regular dressing changes.

93.5% of limbs treated with ACP-01 in a randomized double blind phase II clinical trial experienced healing of ulcers and cessation of pain.

ACP-01 Treatment Restores Circulation.

ACP-01 improves circulation in the distal extremity and decreases limb amputation by:

1. Improving leg circulation through new blood vessel formation (angiogenesis). This results because ACP-01:

  • Is programmed to form blood vessels.
  • Exerts a potent paracrine effect, by secreting vascular endothelial growth factor (VEGF) and angiogenin. Note the high levels of VEGF and angiogenin associated with ACP-01, as compared to controls.

  • Is enriched with CD34+ cells, which amplify the angiogenic response to improve blood flow through the leg.

2. Cell migration to areas of decreased blood flow (ischemia) because they express surface receptors (CXCR4), which are attracted to proteins (chemokine CXCL12) released by the ischemic leg tissue. The ACP-01 embed and repopulate injured tissue, releasing growth factors to promote healing.

Note ACP cells adherent to blood vessels in injured tissue.

3. Release Interleukin 8 which:

  • Attracts CD 34+ cells from the peripheral circulation to improve circulation.
  • Decreases cell death (anti-apoptotic) by increasing the expression of molecules such as the Nuclear Factor Kappa B.
  • Improve healing and regeneration of blood vessels and injured tissue by attracting cells (macrophages) that clear cell debris but minimize inflammation. The ACP promote the “M2 Anti-inflammatory” healing.

Note the very high levels of Interleukin 8, also known as Chemokine CXCL8.

These mechanisms collectively contribute to observed clinical improvements.

Treatment Outcomes

Hemostemix’s ACP-01 therapy has peer reviewed published benefits that improve (decrease) symptoms of chronic stable angina, particularly in reducing chest pain at rest, enhancing exercise capacity and reducing angina severity as measured by the Canadian Cardiovascular Society (CCS) grading system. Scientific Basis for ACP-01’s Efficacy:

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