CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

N/AActive Not RecruitingNCT03455725

BioCardia, Inc.343 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

343

Conditions

Refractory Angina Chronic Myocardial Ischemia

Interventions

CardiAMP Cell Therapy SystemDEVICE

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 TreatmentOTHER

Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female 21 to 80 years of age 2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina. 3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs. 4. Evidence of inducible myocardial ischemia on baseline stress testing 5. Obstructive coronary disease unsuitable for conventional revascularization 6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period). 7. Able to complete an exercise tolerance test on the treadmill 8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography. 9. 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.

Locations (2)

University of Florida

Gainesville, Florida, United States

University of Wisconsin Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 6 months visit

Secondary Outcomes

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%.

Time frame: at 6 months follow-up

Safety: Total Major adverse cardiac events (MACE) at 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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