Ischemic Heart FailureNCT06258447
CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
A study testing Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system in people with Ischemic Heart Failure, run by BioCardia, Inc. at 5 sites in United States.
Trial summary
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Ischemic Heart Failure
- What is being tested?
- Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2024to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
- Left ventricular ejection fraction >20% and <40%
- On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
- NTproBNP level of >500 pg/ml
- Autologous cell analysis score consistent with study selection assessment
Who cannot join
- Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Tanveer Kauser Clinical Coordinator, tanveer.kauser@emory.edu
- Recruiting
Morton Plant Hospital - BayCare
Clearwater, Florida, 33756
Delia Johnson, RN, Delia.Johnson@baycare.org
Leslie Miller, MD
- Withdrawn
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Melanee Schimmel Clinical Coordinator, MSchimm2@hfhs.org
- Recruiting
University of Wisconsin-Division of Cardiovascular Medicine
Madison, Wisconsin, 53792
Besa Jonuzi, bjonuzi@wisc.edu
About this study
Official title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
Read the detailed description
Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.
- Conditions
- Ischemic Heart Failure
- Being tested
- Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy systemDevice
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Study (ABM MNC) Treatment | Experimental | Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system Receives: Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system |
| Control Treatment | Sham comparator | Left ventricular (diagnostic) catheterization but no administration of ABM MNC Receives: Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)
Measured: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary outcomes (7)
First Secondary Endpoint
Time to all-cause death, LVAD/heart transplant, or heart failure hospitalization
Measured: Baseline through study completion, maximum of two years
Second Secondary Endpoint
Cumulative heart failure hospitalizations
Measured: Baseline through study completion, maximum of two years
Third Secondary Endpoint
Time to first heart failure hospitalization
Measured: Baseline through study completion, maximum of two years
Fourth Secondary Endpoint
Change in quality of life as measured using the MLwHF questionnaire based on a scale of 0-105, with 0 being best.
Measured: Baseline to 12 months, 24 months
Fifth Secondary Endpoint
Change in quality of life as measured using the Kansas City Cardiomyopathy questionnaire (KCCQ), based on a scale of 0-100, with 100 being best
Measured: Baseline to 12 months, 24 months
Sixth Secondary Endpoint
Change in functional capacity as measured using the 6-minute walk test (6MWT)
Measured: Baseline to 12 months, 24 months
Seventh Secondary Endpoint
Modified Primary Efficacy Endpoint consisting of all-cause death, LVAD/heart transplant, heart failure hospitalizations and worsening heart failure events treated as an outpatient but without a quality-of-life measure
Measured: Baseline through study completion, maximum of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Aug 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled study of study treatment consisting of intramyocardial autologous cell injections compared to sham control, both performed in cardiac catheterization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioCardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amish Raval, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258447
- Sponsor's protocol ID
- 05804 (CLIN)
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan at this time to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
- ClinicalTrials.gov ID
- NCT06258447
- Acronym / sponsor ID
- 05804 (CLIN)
- Conditions
- Ischemic Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- BioCardia, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
Detailed description
Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled study of study treatment consisting of intramyocardial autologous cell injections compared to sham control, both performed in cardiac catheterization
| Arm | Type | Receives |
|---|---|---|
| Study (ABM MNC) Treatment | Experimental | Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy systemLeft ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system |
| Control Treatment | Sham comparator | Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy systemLeft ventricular (diagnostic) catheterization but no administration of ABM MNC |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
- Left ventricular ejection fraction >20% and <40%
- On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
- NTproBNP level of >500 pg/ml
Key exclusion criteria (1 listed)
- Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy systemthe ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization. | Device | Control Treatment, Study (ABM MNC) Treatment |
Primary outcome
Primary Efficacy Endpoint
Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)
7 secondary outcomes
First Secondary Endpoint
Time frame: Baseline through study completion, maximum of two years
Second Secondary Endpoint
Time frame: Baseline through study completion, maximum of two years
Third Secondary Endpoint
Time frame: Baseline through study completion, maximum of two years
Fourth Secondary Endpoint
Time frame: Baseline to 12 months, 24 months
Fifth Secondary Endpoint
Time frame: Baseline to 12 months, 24 months
Sixth Secondary Endpoint
Time frame: Baseline to 12 months, 24 months
Seventh Secondary Endpoint
Time frame: Baseline through study completion, maximum of two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. No plan at this time to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amish Raval, MD principal investigator
University of Wisconsin, Madison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system in people with Ischemic Heart Failure, run by BioCardia, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debby Holmes-Higgin, MS, MPH (650-226-0120, debbyhh@biocardia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.