Back to resultsCardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (CardiAMP CMI)
Primary Purpose
Refractory Angina, Chronic Myocardial Ischemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CardiAMP Cell Therapy System
Sham Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Angina focused on measuring Cardiovascular Stem Cell Therapy, Bone Marrow Mononuclear Stem Cells, Intramyocardial Injection
Eligibility Criteria
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.
Sites / Locations
- University of Wisconsin MadisonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
CardiAMP cell therapy system
Sham procedure control
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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%.
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.
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.
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03455725
Brief Title
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
Acronym
CardiAMP CMI
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCardia, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Angina, Chronic Myocardial Ischemia
Keywords
Cardiovascular Stem Cell Therapy, Bone Marrow Mononuclear Stem Cells, Intramyocardial Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.
Allocation
Randomized
Enrollment
343 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CardiAMP cell therapy system
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham procedure control
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
CardiAMP Cell Therapy System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Treatment
Intervention Description
Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
Primary Outcome Measure Information:
Title
Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol
Description
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).
Time Frame
Baseline and 6 months visit
Secondary Outcome Measure Information:
Title
Safety: overall survival at 6 months follow-up
Description
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%.
Time Frame
at 6 months follow-up
Title
Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up
Description
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.
Time Frame
from randomisation to 6 months follow-up
Title
Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up
Description
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.
Time Frame
Baseline and at 6 months follow-up
Title
Efficacy: Change of angina frequency (per week) at 12 months follow-up
Description
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.
Time Frame
Baseline and at 12 months follow-up
Title
Efficacy: Change of Angina Frequency (per week) at 6 months follow-up
Description
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.
Time Frame
Baseline and at 6 months follow-up
Title
Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up
Description
Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period
Time Frame
From randomisation to 12 month follow-up
Title
Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)
Description
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.
Time Frame
From randomization to 12 Months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Altman, PhD
Phone
(650) 226 0135
Email
info@biocardia.com
Facility Information:
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassondra Vander Ark, RN
Phone
608-265-0612
Email
cav@medicine.wisc.edu
First Name & Middle Initial & Last Name & Degree
Amish Raval, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://biocardia.com
Description
company website
Learn more about this trial
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
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