CardiAMP™ Cell Therapy Heart Failure Trial
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|ClinicalTrials.gov Identifier: NCT02438306|
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : March 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Biological: Autologous cell therapy Other: Sham||Phase 3|
Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.
The AHA also estimates that one in five adults will develop heart failure after the age of 40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.
CardiAMP is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform, and (ii) a biotherapeutic delivery system. CardiAMP is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic systolic heart failure, which is heart failure that develops after a heart attack. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a centralized diagnostic lab, which tests the sample. During the treatment, a clinician harvests and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.
BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: CardiAMP cell therapy
Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
Biological: Autologous cell therapy
Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.
Sham Comparator: Sham Comparator
Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.
- A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. [ Time Frame: 12 Months ]The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.
- Survival Rate [ Time Frame: 12 Months ]Survival rate compared between both study arms (non-inferiority, treatment vs sham)
- Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]Freedom from MACE, defined as the composite of all-cause death, hospitalization for worsening heart failure, nonfatal recurrent myocardial infarction, placement of a left ventricular assist device (LVAD), or heart transplantation (non-inferiority, treatment vs sham)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 12 months ]Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)
- Time to first MACE [ Time Frame: 12 months ]Time (in days) to first MACE during the 12 months after the baseline measurements (superiority, treatment vs sham)
- Survival rate [ Time Frame: 12 months ]Survival rate compared between both study arms (superiority, treatment vs sham)
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|Ages Eligible for Study:||21 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- New York Heart Association (NYHA) Class II or III
- A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
- On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
- Left ventricular ejection fraction between 20% and 40%.
- Qualification of a pre-procedure screening of bone-marrow aspiration
• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438306
|Contact: Peter Altman, PhDemail@example.com|
|Principal Investigator:||Carl Pepine, MD||University of Florida|
|Principal Investigator:||Amish Raval, MD||University of Wisconsin, Madison|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||BioCardia, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 8, 2015 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|