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CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (CardiAMP CMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455725
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
BioCardia, Inc.

Study Description
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Brief 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 Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)


Condition or disease Intervention/treatment Phase
Refractory Angina Chronic Myocardial Ischemia Device: CardiAMP Cell Therapy System Other: Sham Treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.
Primary Purpose: Treatment
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)
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CardiAMP cell therapy system

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.

 Device: CardiAMP Cell Therapy System
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 Comparator: Sham procedure control

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)

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 21 to 80 years of age
  2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
  3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
  4. Evidence of inducible myocardial ischemia on baseline stress testing
  5. Obstructive coronary disease unsuitable for conventional revascularization
  6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
  7. Able to complete an exercise tolerance test on the treadmill
  8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
  9. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455725


Contacts
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Contact: Peter Altman, PhD (650) 226 0135 info@biocardia.com

Locations
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United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cassondra Vander Ark, RN    608-265-0612    cav@medicine.wisc.edu   
Principal Investigator: Amish Raval, MD         
Sponsors and Collaborators
BioCardia, Inc.
More Information
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Additional Information:

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Responsible Party: BioCardia, Inc.
ClinicalTrials.gov Identifier: NCT03455725    
Other Study ID Numbers: 04747 (CLIN)
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by BioCardia, Inc.:
Cardiovascular Stem Cell Therapy
Bone Marrow Mononuclear Stem Cells
Intramyocardial Injection
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases