Refractory AnginaCardiAMP-CMINCT03455725
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
A study testing CardiAMP Cell Therapy System in people with Refractory Angina and Chronic Myocardial Ischemia, run by BioCardia, Inc. at 2 sites in United States.
Trial summary
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Refractory Angina, Chronic Myocardial Ischemia
- What is being tested?
- CardiAMP Cell Therapy System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2021to Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 21 to 80 years of age
- Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
- Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
- Evidence of inducible myocardial ischemia on baseline stress testing
- Obstructive coronary disease unsuitable for conventional revascularization
- Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
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- Able to complete an exercise tolerance test on the treadmill
- Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
- Qualification of a pre-procedure screening of bone-marrow aspiration
Who cannot join
- Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32610
University of Wisconsin Madison
Madison, Wisconsin, 53792
About this study
Official title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment
Treatment Group:
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)
- Conditions
- Refractory Angina, Chronic Myocardial Ischemia
- Being tested
- CardiAMP Cell Therapy System, Sham Treatment
- Keywords
- Cardiovascular Stem Cell Therapy, Bone Marrow Mononuclear Stem Cells, Intramyocardial Injection
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiAMP Cell Therapy SystemDevice
The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters.
Sham TreatmentOther
Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
| Study group | Role | What they receive |
|---|---|---|
| CardiAMP cell therapy system | Active comparator | Roll-in phase:
Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase.
In the subsequent randomized phase:
Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system. Receives: Device: CardiAMP Cell Therapy System |
| Sham procedure control | Sham comparator | Randomized phase:
Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells) Receives: Other: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol
A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).
Measured: Baseline and 6 months visit
Secondary outcomes (7)
Safety: overall survival at 6 months follow-up
A non-inferiority analysis of overall survival at 6-months will be made comparing the Treatment group to the Sham Control group using a non-inferiority margin of 10%.
Measured: at 6 months follow-up
Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up
A non-inferiority analysis with regard to Total Major Adverse Cardiac Events (MACE: defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke) at 12 month follow-up, as adjudicated by an independent clinical endpoint classification (CEC) committee with 10% margin.
Measured: from randomisation to 6 months follow-up
Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up
Superiority analysis with regards to change from baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at 6 Month Follow-up Visit. Baseline (BL) is the average of (at least) two total exercise times measured during the screening period.
Measured: Baseline and at 6 months follow-up
Efficacy: Change of angina frequency (per week) at 12 months follow-up
Superiority analysis with regards to change in angina frequency (episodes per week) at 12 month follow-up Visit versus baseline angina frequency (per week).
Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 12-month follow-up visits.
Measured: Baseline and at 12 months follow-up
Efficacy: Change of Angina Frequency (per week) at 6 months follow-up
Superiority analysis with regards to change in angina frequency at 6 month follow-up visit versus baseline (expressed as angina frequency per week).
Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline and in the 4 weeks before the 6-month follow-up visits.
Measured: Baseline and at 6 months follow-up
Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up
Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period
Measured: From randomisation to 12 month follow-up
Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)
Superiority analysis with regards to percentage of participants with at least one SAE. From randomization until the end of the 12 month follow-up period.
Measured: From randomization to 12 Months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start30 Jun 2021
- Primary completion19 Feb 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory AnginaStudies 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
- Prospective, multi-center, 2:1 randomized (Treatment vs Sham Control), blinded trial comparing 2 paralel groups of patients with CMI treated with CardiAMP cell therapy system vs sham treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 343 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
- NCT03455725
- Sponsor's protocol ID
- 04747 (CLIN)
- Acronym
- CardiAMP-CMI
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2018
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)
- ClinicalTrials.gov ID
- NCT03455725
- Acronym / sponsor ID
- CardiAMP-CMI / 04747 (CLIN)
- Conditions
- Refractory Angina, Chronic Myocardial Ischemia
- Keywords
- Cardiovascular Stem Cell Therapy, Bone Marrow Mononuclear Stem Cells, Intramyocardial Injection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- BioCardia, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Mar 2018 (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.
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment
Treatment Group:
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)
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
- Prospective, multi-center, 2:1 randomized (Treatment vs Sham Control), blinded trial comparing 2 paralel groups of patients with CMI treated with CardiAMP cell therapy system vs sham treatment.
| Arm | Type | Receives |
|---|---|---|
| CardiAMP cell therapy system | Active comparator | Device: CardiAMP Cell Therapy SystemRoll-in phase: Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system. |
| Sham procedure control | Sham comparator | Other: Sham TreatmentRandomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female 21 to 80 years of age
- Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
- Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
- Evidence of inducible myocardial ischemia on baseline stress testing
- Obstructive coronary disease unsuitable for conventional revascularization
Key exclusion criteria (1 listed)
- Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
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 |
|---|---|---|
| CardiAMP Cell Therapy SystemThe CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters. | Device | CardiAMP cell therapy system |
| Sham TreatmentPatients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed | Other | Sham procedure control |
Primary outcome
Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol
Time frame: Baseline and 6 months visit
A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).
7 secondary outcomes
Safety: overall survival at 6 months follow-up
Time frame: at 6 months follow-up
Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up
Time frame: from randomisation to 6 months follow-up
Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up
Time frame: Baseline and at 6 months follow-up
Efficacy: Change of angina frequency (per week) at 12 months follow-up
Time frame: Baseline and at 12 months follow-up
Efficacy: Change of Angina Frequency (per week) at 6 months follow-up
Time frame: Baseline and at 6 months follow-up
Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up
Time frame: From randomisation to 12 month follow-up
Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)
Time frame: From randomization to 12 Months follow-up
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 6 Jan 2026.
- company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Amish Raval, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardiAMP Cell Therapy System in people with Refractory Angina and Chronic Myocardial Ischemia, run by BioCardia, Inc. at 2 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 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol (time frame: Baseline and 6 months visit). 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 6 Jan 2026.