CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (CardiAMP CMI)
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|ClinicalTrials.gov Identifier: NCT03455725|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : October 7, 2021
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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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||343 participants|
|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.|
|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|
Active Comparator: CardiAMP cell therapy system
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
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
- 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).
- 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%.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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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|
- 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
Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
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
|Contact: Peter Altman, PhD||(650) 226 firstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin Madison||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cassondra Vander Ark, RN 608-265-0612 email@example.com|
|Principal Investigator: Amish Raval, MD|
|Responsible Party:||BioCardia, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
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