CardiAMP™ Cell Therapy Heart Failure Trial

Sponsor

BioCardia, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02438306

Collaborator

(none)

250

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.3

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 Disease	Intervention/Treatment	Phase
Heart Failure	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)

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/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.

Arm

Intervention/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

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

Survival Rate [12 Months]
Survival rate compared between both study arms (non-inferiority, treatment vs sham)
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)
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)
Time to first MACE [12 months]
Time (in days) to first MACE during the 12 months after the baseline measurements (superiority, treatment vs sham)
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:

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

	Site	City	State	Country	Postal Code
1	Cardiology PC	Birmingham	Alabama	United States	35211
2	Mayo Clinic	Phoenix	Arizona	United States	85054
3	USC	Los Angeles	California	United States	90033
4	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
5	Stanford Medical Center, Stanford Health Care	Palo Alto	California	United States	94305
6	California Pacific Medical Center	San Francisco	California	United States	94115
7	University of Colorado, Denver	Aurora	Colorado	United States	80045
8	MedStar Health Research Institute	Washington	District of Columbia	United States	20010
9	Morton Plant Mease Health Care	Clearwater	Florida	United States	33756
10	University of Florida - College of Medicine/ div of Cardiovascular Medicine	Gainesville	Florida	United States	32606
11	Northwestern University	Chicago	Illinois	United States	60611
12	Iowa Heart	Des Moines	Iowa	United States	50266
13	John Hopkins University School of Medicine - Dept of Cardiology	Baltimore	Maryland	United States	21287
14	Suburban Hospital	Bethesda	Maryland	United States	20814
15	Henry Ford Hospital	Detroit	Michigan	United States	48202
16	Michigan Cardiovascular Institute	Saginaw	Michigan	United States	48601
17	Michigan Heart - St.Joseph Mercy Health System (Trinity Health)	Ypsilanti	Michigan	United States	48197
18	University of Minnesota	Minneapolis	Minnesota	United States	55455
19	Saint Luke's Hospital	Kansas City	Missouri	United States	64111
20	Atlantic Health System	Morristown	New Jersey	United States	07960
21	New York University School of Medicine	New York	New York	United States	10010
22	Cornell University	New York	New York	United States	10065
23	Cleveland Clinic	Cleveland	Ohio	United States	44195
24	Oklahoma Heart	Tulsa	Oklahoma	United States	74104
25	Stern Cardiovascular Foundation	Memphis	Tennessee	United States	38103
26	Texas Heart Institute	Houston	Texas	United States	77030
27	Virginia Commonwealth University (VCU) Medical Center	Richmond	Virginia	United States	23298
28	Swedish Health Services	Seattle	Washington	United States	98122
29	Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792-0001
30	Ottawa Heart Institute	Ottawa	Ontario	Canada	KIY 4W7

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:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Aug 3, 2022