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Increasing Cardiac Ejection Fraction, Quality of Life and Function

ACP-01 increases circulation, improves cardiac performance, reduces pain and helps patients with vascular conditions regain daily function.

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Heart Treatments

Refractory Heart Failure

Persistent shortness of breath (dyspnea) at rest or with minimal exertion, fatigue, leg swelling, palpitations, nausea and impaired thinking.

Symptoms

Ejection Fraction (EF) ≤ 40%

Measured via echocardiography, cardiac MRI, or ventriculography, indicating severe systolic dysfunction.

Reduced Cardiac Output & Index

Cardiac Index (CI) < 2.0 L/min/m² on right heart catheterization (RHC), reflecting end-stage heart failure.

Elevated BNP/NT-proBNP

Very high levels of B-type natriuretic peptide (BNP) or N-terminal proBNP, suggesting severe heart failure.

Severe Myocardial Scar & Viability Loss

Confirmed by cardiac MRI or PET scan, indicating extensive fibrosis and lack of viable myocardium.

Failure of Medical Management

We’re seeing worsening symptoms despite optimal medical management.

Test Results

ACP-01 increases heart function by:

1. Improving microcirculation through new blood vessel formation (angiogenesis). This is because ACP-01 :

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

  • Are enriched with CD34+ cells, which amplify the angiogenic response to improve myocardial perfusion.

2. ACP-01 promotes cell migration to areas of decreased blood flow (ischemia) and injured heart tissue (myocardium) through:

  • Expression of surface receptors (CXCR4) on the ACP-01, which home toward signalling proteins (chemokine CXCL12) released by myocardial injury. These cells embed and repopulate injured tissue, releasing growth factors.

3. Release Interleukin 8 (Chemokine CXCL8) which:

  • Attracts CD 34+ cells from the peripheral circulation to improve angiogenesis in the ischemic heart.
  • Improve healing and regeneration, and decrease scarring of injured myocardium by attracting cells (macrophages) that clear cell debris, but minimize inflammation. This results from ACP-01 promotion of 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:

Increased Ejection Fraction (EF)

1. Improvement: ACP-01 has been shown to increase left ventricular ejection fraction (LVEF) in ischemic cardiomyopathy patients. Increased LVEF (enhanced cardiac output) reduces heart failure symptoms and improves quality of life.

2. Patients experienced decreased angina.

Improved Angina Symptoms & Reduced Chest Pain

1. Improvement: patients reported a reduction in angina frequency and severity, with some experiencing complete resolution of chest pain.

2. Clinical Significance: Fewer episodes of ischemia-induced pain translate to improved quality of life and exercise capacity.

Enhanced Exercise Tolerance & Functional Capacity

1. Improvement: documented increases in Six-Minute Walk Test distances and NYHA heart failure classification.

2. Clinical Significance: Improved exercise tolerance means patients can walk longer distances without experiencing dyspnea or fatigue.

Increased Myocardial Perfusion & Viability

1. Improvement: imaging studies (e.g., SPECT, PET, or MRI) showed improved perfusion in previously ischemic areas.

2. Clinical Significance: Enhanced perfusion helps preserve myocardial function and reduces the progression of heart failure.

Reduction in Hospitalization Rates & Improved Survival

1. Improvement: Patients treated with ACP-01 showed fewer hospitalizations due to heart failure and lower mortality rates compared to standard care.

2. Clinical Significance: this suggests a disease-modifying effect, delaying the need for left ventricular assistive device or heart transplant.

Solution

ACP-01 injected into the heart regenerates heart functions. Hemostemix’s peer-reviewed literature on ACP-01 for ischemic cardiomyopathy (ICM) has documented several key clinical improvements, including: increased LVEF, reduced symptoms of heart failure, and improved quality of life.

Refractory Heart Failure

Persistent shortness of breath (dyspnea) at rest or with minimal exertion, fatigue, leg swelling, palpitations, nausea and impaired thinking.

Fatigue

Tiredness with modest exertion.

Nausea

Nausea, dizziness, or sweating during the episode.

Symptoms

Ejection Fraction (EF) ≤ 40%

Measured via echocardiography, cardiac MRI, or ventriculography, indicating severe systolic dysfunction.

Reduced Cardiac Output & Index

Cardiac Index (CI) < 2.0 L/min/m² on right heart catheterization (RHC), reflecting end-stage heart failure.

Stress Testing

To measure cardiac functions under conditions of physical stress.

Electrocardiogram

Measure electrical activity, conduction delay and abnormalities of heart rhythm.

Elevated BNP/NT-proBNP

High levels of B-type natriuretic peptide (BNP) or N-terminal proBNP, suggesting severe heart failure.

Myocardial Scar & Viability Loss

Assessed by cardiac MRI or PET scan, indicating extensive fibrosis and lack of viable myocardium.

Genetic Testing

Genetic testing for patients with family history of dilated cardiomyopathy.

Cardiac Angiography

To assess coronary artery flow, stenosis, or blockage.

Test Results

Enhanced Myocardial Perfusion:

  • Mechanism: ACP-01 consists of autologous angiogenic cell precursors that promote neovascularization, leading to improved blood flow in ischemic myocardial regions.
  • Outcome: Increased perfusion reduces ischemia during physical exertion, thereby enhancing exercise tolerance and decreasing the frequency and severity of angina episodes.

Reduction in Myocardial Ischemia:

  • Mechanism: By improving blood supply to the heart muscle, ACP-01 reduces the mismatch between oxygen supply and demand during exertion.
  • Outcome: This reduction in ischemia translates to improved exercise capacity and a lower CCS angina class, indicating milder symptoms.

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:

Increased Ejection Fraction (EF)

1. Improvement: ACP-01 has been shown to increase left ventricular ejection fraction (LVEF) in ischemic cardiomyopathy patients. Increased LVEF (enhanced cardiac output) reduce heart failure symptoms and improves quality of life.

2. Patients experienced decreased angina.

Improved Angina Symptoms & Reduced Chest Pain

1. Improvement: patients reported a reduction in angina frequency and severity, with some experiencing complete resolution of chest pain.

2. Clinical Significance: Fewer episodes of ischemia-induced pain translate to improved quality of life and exercise capacity.

Enhanced Exercise Tolerance & Functional Capacity

1. Improvement: documented increases in Six-Minute Walk Test distances and NYHA heart failure classification.

2. Clinical Significance: Improved exercise tolerance means patients can walk longer distances without experiencing dyspnea or fatigue.

Increased Myocardial Perfusion & Viability

1. Improvement: imaging studies (e.g., SPECT, PET, or MRI) showed improved perfusion in previously ischemic areas.

2. Clinical Significance: Enhanced perfusion helps preserve myocardial function and reduces the progression of heart failure.

Reduction in Hospitalization Rates & Improved Survival

1. Improvement: Patients treated with ACP-01 showed fewer hospitalizations due to heart failure and lower mortality rates compared to standard care.

2. Clinical Significance: this suggests a disease-modifying effect, delaying the need for left ventricular assistive device or heart transplant.

Solution

ACP-01 injected into the heart regenerates heart functions. Hemostemix’s peer-reviewed literature on ACP-01 for ischemic cardiomyopathy (ICM) has documented several key clinical improvements, including:

Recurrent Chest Pain (Angina)

Chronic, severe angina that is unresponsive to medication or revascularization. Symptoms include chest pain, nausea and radiating pain to the left arm or jaw.

Symptoms

Ejection Fraction (EF) ≤ 40%

Measured via echocardiography, cardiac MRI, or ventriculography, indicating severe systolic dysfunction.

Reduced Cardiac Output & Index

Cardiac Index (CI) < 2.0 L/min/m² on right heart catheterization (RHC), reflecting end-stage heart failure.

Stress Testing

To measure cardiac functions under conditions of physical stress.

Electrocardiogram

Measure electrical activity, conduction delay and abnormalities of heart rhythm.

Elevated BNP/NT-proBNP

High levels of B-type natriuretic peptide (BNP) or N-terminal proBNP, suggesting severe heart failure.

Myocardial Scar & Viability Loss

Assessed by cardiac MRI or PET scan, indicating extensive fibrosis and lack of viable myocardium.

Genetic Testing

Genetic testing for patients with family history of dilated cardiomyopathy.

Cardiac Angiography

To assess coronary artery flow, stenosis, or blockage.

Test Results

Enhanced Myocardial Perfusion:

  • Mechanism: ACP-01 consists of autologous angiogenic cell precursors that promote neovascularization, leading to improved blood flow in ischemic myocardial regions.
  • Outcome: Increased perfusion reduces ischemia during physical exertion, thereby enhancing exercise tolerance and decreasing the frequency and severity of angina episodes.

Reduction in Myocardial Ischemia:

  • Mechanism: By improving blood supply to the heart muscle, ACP-01 reduces the mismatch between oxygen supply and demand during exertion.
  • Outcome: This reduction in ischemia translates to improved exercise capacity and a lower CCS angina class, indicating milder symptoms.

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:

Increased Ejection Fraction (EF)

1. Improvement: ACP-01 has been shown to increase left ventricular ejection fraction (LVEF) in ischemic cardiomyopathy patients. Increased LVEF (enhanced cardiac output) reduce heart failure symptoms and improves quality of life.

2. Patients experienced decreased angina.

Improved Angina Symptoms & Reduced Chest Pain

1. Improvement: patients reported a reduction in angina frequency and severity, with some experiencing complete resolution of chest pain.

2. Clinical Significance: Fewer episodes of ischemia-induced pain translate to improved quality of life and exercise capacity.

Enhanced Exercise Tolerance & Functional Capacity

1. Improvement: documented increases in Six-Minute Walk Test distances and NYHA heart failure classification.

2. Clinical Significance: Improved exercise tolerance means patients can walk longer distances without experiencing dyspnea or fatigue.

Increased Myocardial Perfusion & Viability

1. Improvement: imaging studies (e.g., SPECT, PET, or MRI) showed improved perfusion in previously ischemic areas.

2. Clinical Significance: Enhanced perfusion helps preserve myocardial function and reduces the progression of heart failure.

Reduction in Hospitalization Rates & Improved Survival

1. Improvement: Patients treated with ACP-01 showed fewer hospitalizations due to heart failure and lower mortality rates compared to standard care.

2. Clinical Significance: this suggests a disease-modifying effect, delaying the need for left ventricular assistive device or heart transplant.

Solution

ACP-01 injected into the heart regenerates heart functions. Hemostemix’s peer-reviewed literature on ACP-01 for ischemic cardiomyopathy (ICM) has documented several key clinical improvements, including:

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