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NCT Number: NCT03455725

CardiAMP Cell Therapy Chronic Myocardial Ischemia 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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Refractory Angina Angina Pectoris Cardiovascular Diseases Chest Pain Chronic Myocardial Ischemia Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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

Exclusion criteria

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

Treatment and study plan

CardiAMP Cell Therapy System

Device

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 Treatment

Other

Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed

Primary outcomes

  1. 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).

Secondary outcomes

  1. Safety: overall survival at 6 months follow-up

    Time frame: 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%.

  2. Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up

    Time frame: from randomisation to 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.

  3. Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up

    Time frame: Baseline and 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.

  4. Efficacy: Change of angina frequency (per week) at 12 months follow-up

    Time frame: Baseline and 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.

  5. Efficacy: Change of Angina Frequency (per week) at 6 months follow-up

    Time frame: Baseline and 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.

  6. Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up

    Time frame: From randomisation to 12 month follow-up

    Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period

  7. Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)

    Time frame: From randomization to 12 Months follow-up

    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.

Sponsors and collaborators

Lead sponsor

BioCardia, Inc.

Industry

Registry information

Official study 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)

Acronym: CardiAMP-CMI

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 7, 2018
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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