CardiAMP™ Cell Therapy for Heart Failure Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02438306 |
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Recruitment Status :
Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : October 10, 2023
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | May 5, 2015 | |||||||||
| First Posted Date ICMJE | May 8, 2015 | |||||||||
| Last Update Posted Date | October 10, 2023 | |||||||||
| Actual Study Start Date ICMJE | December 2016 | |||||||||
| Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE |
Change in Six (6) Minute Walk Distance at 12 months from baseline [ Time Frame: 12 months ] | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | CardiAMP™ Cell Therapy for Heart Failure Trial | |||||||||
| Official Title ICMJE | 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) | |||||||||
| Brief Summary | 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. | |||||||||
| Detailed Description | 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 |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Heart Failure, Systolic | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE |
125 | |||||||||
| Original Estimated Enrollment ICMJE |
250 | |||||||||
| Estimated Study Completion Date ICMJE | December 2026 | |||||||||
| Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: • Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination. |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years to 90 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Canada, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT02438306 | |||||||||
| Other Study ID Numbers ICMJE | BC-14-001 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE |
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| Current Responsible Party | BioCardia, Inc. | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | BioCardia, Inc. | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | BioCardia, Inc. | |||||||||
| Verification Date | October 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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