CardiAMP™ Cell Therapy for Heart Failure Trial
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|ClinicalTrials.gov Identifier: NCT02438306|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : October 10, 2023
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Systolic||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 cell therapy is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform and (ii) a biotherapeutic delivery system. CardiAMP cell therapy is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic heart failure with reduced ejection fraction. 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 central diagnostic lab, which tests the sample. For the study treatment, a clinician collects 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 :||125 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 Ischemic Heart Failure (CardiAMP Heart Failure Trial)|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2026|
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.
- 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)
- Survival [ Time Frame: 12 Months ]Overall survival compared between both study arms (non-inferiority, treatment vs sham)
- Time to first Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]Time to first 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)
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
|Principal Investigator:||Carl Pepine, MD||University of Florida|
|Principal Investigator:||Amish Raval, MD||University of Wisconsin, Madison|
|Principal Investigator:||Duncan Stewart, MD||Ottawa Heart Institute Research Corporation|