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)
Conditions:
🦠 Refractory Angina 🦠 Chronic Myocardial Ischemia
🗓️ Study Start (Actual) 30 June 2021
🗓️ Primary Completion (Estimated) December 2023
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 343
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Madison, Wisconsin, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 February 2018
  • First Submitted that Met QC Criteria 28 February 2018
  • First Posted 7 March 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 October 2023
  • Last Update Posted 6 October 2023
  • Last Verified October 2023