CardiAMP™ Cell Therapy Heart Failure Trial

Sponsor
BioCardia, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02438306
Collaborator
(none)
250
Enrollment
26
Locations
2
Arms
72
Duration (Months)
9.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects may occur.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Autologous cell therapy
  • Other: Sham
Phase 3

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 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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
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.

Other: Sham
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.

Outcome Measures

Primary Outcome Measures

  1. A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. [12 Months]

    The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.

Secondary Outcome Measures

  1. Survival Rate [12 Months]

    Survival rate compared between both study arms (non-inferiority, treatment vs sham)

  2. Major Adverse Cardiac Events (MACE) [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)

  3. Minnesota Living with Heart Failure Questionnaire (MLHFQ) [12 months]

    Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)

  4. Time to first MACE [12 months]

    Time (in days) to first MACE during the 12 months after the baseline measurements (superiority, treatment vs sham)

  5. Survival rate [12 months]

    Survival rate compared between both study arms (superiority, treatment vs sham)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cardiology PCBirminghamAlabamaUnited States35211
2Mayo ClinicPhoenixArizonaUnited States85054
3USCLos AngelesCaliforniaUnited States90033
4Cedars Sinai Medical CenterLos AngelesCaliforniaUnited States90048
5Stanford Medical Center, Stanford Health CarePalo AltoCaliforniaUnited States94305
6California Pacific Medical CenterSan FranciscoCaliforniaUnited States94115
7University of Colorado, DenverAuroraColoradoUnited States80045
8MedStar Health Research InstituteWashingtonDistrict of ColumbiaUnited States20010
9Morton Plant Mease Health CareClearwaterFloridaUnited States33756
10University of Florida - College of Medicine/ div of Cardiovascular MedicineGainesvilleFloridaUnited States32606
11Northwestern UniversityChicagoIllinoisUnited States60611
12Iowa HeartDes MoinesIowaUnited States50266
13John Hopkins University School of Medicine - Dept of CardiologyBaltimoreMarylandUnited States21287
14Suburban HospitalBethesdaMarylandUnited States20814
15Henry Ford HospitalDetroitMichiganUnited States48202
16Michigan Cardiovascular InstituteSaginawMichiganUnited States48601
17Michigan Heart - St.Joseph Mercy Health System (Trinity Health)YpsilantiMichiganUnited States48197
18University of MinnesotaMinneapolisMinnesotaUnited States55455
19Atlantic Health SystemMorristownNew JerseyUnited States07960
20New York University School of MedicineNew YorkNew YorkUnited States10010
21Cornell UniversityNew YorkNew YorkUnited States10065
22Oklahoma HeartTulsaOklahomaUnited States74104
23Texas Heart InstituteHoustonTexasUnited States77030
24Virginia Commonwealth University (VCU) Medical CenterRichmondVirginiaUnited States23298
25Swedish Health ServicesSeattleWashingtonUnited States98122
26Division of Cardiovascular Medicine, University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States53792-0001

Sponsors and Collaborators

  • BioCardia, Inc.

Investigators

  • Principal Investigator: Carl Pepine, MD, University of Florida
  • Principal Investigator: Amish Raval, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
BioCardia, Inc.
ClinicalTrials.gov Identifier:
NCT02438306
Other Study ID Numbers:
  • BC-14-001
First Posted:
May 8, 2015
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021