CardiAMP CMI: CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CardiAMP cell therapy system 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. |
Device: CardiAMP Cell Therapy System
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.
|
| Sham Comparator: Sham procedure control 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) |
Other: Sham Treatment
Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol [Baseline and 6 months visit]
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).
Secondary Outcome Measures
- Safety: overall survival at 6 months follow-up [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%.
- Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up [from randomisation to 6 months follow-up]
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.
- Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up [Baseline and 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.
- Efficacy: Change of angina frequency (per week) at 12 months follow-up [Baseline and 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.
- Efficacy: Change of Angina Frequency (per week) at 6 months follow-up [Baseline and 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.
- Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up [From randomisation to 12 month follow-up]
Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period
- Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE) [From randomization to 12 Months follow-up]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female 21 to 80 years of age
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Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
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Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
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Evidence of inducible myocardial ischemia on baseline stress testing
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Obstructive coronary disease unsuitable for conventional revascularization
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Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
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Able to complete an exercise tolerance test on the treadmill
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Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
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Qualification of a pre-procedure screening of bone-marrow aspiration
Exclusion Criteria
Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin Madison | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- BioCardia, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 04747 (CLIN)