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Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment
Treatment Group:
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardiAMP cell therapy system | Active Comparator | Roll-in phase: Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system. |
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| Sham procedure control | Sham Comparator | Randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardiAMP Cell Therapy System | Device | The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol | A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol). | Baseline and 6 months visit |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: overall survival at 6 months follow-up | A non-inferiority analysis of overall survival at 6-months will be made comparing the Treatment group to the Sham Control group using a non-inferiority margin of 10%. | at 6 months follow-up |
| Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up |
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Inclusion Criteria:
Exclusion Criteria
Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
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| Name | Affiliation | Role |
|---|---|---|
| Amish Raval, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| University of Wisconsin Madison |
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| Label | URL |
|---|---|
| company website | View source |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Prospective, multi-center, 2:1 randomized (Treatment vs Sham Control), blinded trial comparing 2 paralel groups of patients with CMI treated with CardiAMP cell therapy system vs sham treatment.
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Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.
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| Sham Treatment | Other | Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed |
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A non-inferiority analysis with regard to Total Major Adverse Cardiac Events (MACE: defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke) at 12 month follow-up, as adjudicated by an independent clinical endpoint classification (CEC) committee with 10% margin. |
| from randomisation to 6 months follow-up |
| Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up | Superiority analysis with regards to change from baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at 6 Month Follow-up Visit. Baseline (BL) is the average of (at least) two total exercise times measured during the screening period. | Baseline and at 6 months follow-up |
| Efficacy: Change of angina frequency (per week) at 12 months follow-up | Superiority analysis with regards to change in angina frequency (episodes per week) at 12 month follow-up Visit versus baseline angina frequency (per week). Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 12-month follow-up visits. | Baseline and at 12 months follow-up |
| Efficacy: Change of Angina Frequency (per week) at 6 months follow-up | Superiority analysis with regards to change in angina frequency at 6 month follow-up visit versus baseline (expressed as angina frequency per week). Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline and in the 4 weeks before the 6-month follow-up visits. | Baseline and at 6 months follow-up |
| Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up | Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period | From randomisation to 12 month follow-up |
| Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE) | Superiority analysis with regards to percentage of participants with at least one SAE. From randomization until the end of the 12 month follow-up period. | From randomization to 12 Months follow-up |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |