CardiAMP Cell Therapy for Heart Failure

N/A

Recruiting

Led By Amish Raval, MD

Research Sponsored by BioCardia, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New York Heart Association (NYHA) Class II or III

Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, maximum of two years

Summary

"This trial aims to test the safety and effectiveness of a new treatment called CardiAMP cell therapy system in patients with heart failure caused by reduced blood flow to the heart. The study will involve multiple medical

Who is the study for?

This trial is for people with heart failure due to past heart attacks, who have a weak pumping function (ejection fraction between 20-40%), and certain blood test results. They must be on stable heart medications for at least three months. It's not open to those outside these criteria.

What is being tested?

The study tests if injecting one's own processed bone marrow cells into the heart can improve its function in patients with ischemic heart failure. Participants are randomly assigned to receive either this cell therapy or just a diagnostic procedure.

What are the potential side effects?

Potential side effects may include discomfort at the bone marrow extraction site, infection risk from injections, allergic reactions, and irregular heartbeat. However, specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart condition moderately affects my daily activities.

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My heart's left side is weak due to a past heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion, maximum of two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion, maximum of two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, maximum of two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Endpoint

Secondary study objectives

Fifth Secondary Endpoint

First Secondary Endpoint

Fourth Secondary Endpoint

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study (ABM MNC) TreatmentExperimental Treatment1 Intervention

Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system

Group II: Control TreatmentPlacebo Group1 Intervention

Left ventricular (diagnostic) catheterization but no administration of ABM MNC

0 / 2Eligibility criteria met