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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 6, 2023
Sponsor:
Information provided by (Responsible Party):
BioCardia, Inc.

Tracking Information
First Submitted Date  ICMJE February 28, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date October 6, 2023
Actual Study Start Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2021)
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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
Official Title  ICMJE 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)
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)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Refractory Angina
  • Chronic Myocardial Ischemia
Intervention  ICMJE
  • 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.
  • Other: Sham Treatment
    Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
Study Arms  ICMJE
  • 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.

    Intervention: Device: CardiAMP Cell Therapy System
  • 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)

    Intervention: Other: Sham Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2018)
343
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Altman, PhD (650) 226 0135 info@biocardia.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03455725
Other Study ID Numbers  ICMJE 04747 (CLIN)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party BioCardia, Inc.
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE BioCardia, Inc.
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioCardia, Inc.
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP