Trial Summary
What is the purpose of this trial?This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
Eligibility Criteria
This trial is for people with chronic heart failure due to a past heart attack, who have a left ventricular ejection fraction between 20% and 40%, and are in NYHA Class II or III. They must be on stable heart failure medication for at least three months and pass a bone-marrow screening.Inclusion Criteria
My heart's left side is weak due to a past heart attack.
I have been on a stable heart failure treatment for at least 3 months.
Before the procedure, the doctor needs to check the patient's bone marrow to make sure it is healthy.
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Exclusion Criteria
My heart and blood vessels are healthy based on my recent exams.
Participant Groups
The study tests CardiAMP cell therapy against a sham (fake) procedure. It's blinded, meaning patients and evaluators don't know who gets the real treatment. The trial includes up to 10 initial subjects before full randomization.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CardiAMP cell therapyExperimental Treatment1 Intervention
Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
Group II: Sham ComparatorPlacebo Group1 Intervention
Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
Johns HopkinsBaltimore, MD
Johns Hopkins University School of Medicine - Dept of CardiologyBaltimore, MD
MedStar Health Research InstituteWashington, United States
More Trial Locations
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Who Is Running the Clinical Trial?
BioCardia, Inc.Lead Sponsor