A Study of the Effectiveness and Safety of Targeted Delivery of Auto CD34+ Stem Cells into Heart Muscle for Improving Exercise Capacity in People with Angina Resistant to Treatment

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 11-006936
    NCT ID: NCT01508910
    Sponsor Protocol Number: 901001

About this study

The purpose of the study is to assess the safety and effectiveness of targeted delivery of Auto-CD34+ stem cells into heart muscle tissue to increase exercise time and decrease anginal symptoms in patients who have angina resistant to treatment and chronic heart muscle death.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Male or female
  • Age 21 to 80 years at the time of signing the informed consent
  • Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina
  • Without control of angina symptoms in spite of maximal tolerated doses of anti-angina drugs
    • Must be on optimal therapy for angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form
  • Has obstructive coronary disease unsuitable for conventional revascularization due to unsuitable anatomy or comorbidity as determined at the site and confirmed by an independent adjudication committee
  • Must have evidence of inducible myocardial ischemia
  • Must experience angina episodes
  • Must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization
  • If female of childbearing potential, must not be pregnant and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria

  • Cardiovascular hospitalization within 60 days prior to potential study enrollment
  • Has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment
  • Has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment
  • Has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment
  • Has a history of moderate to severe aortic stenosis,  severe aortic insufficiency, severe mitral stenosis, severe mitral insufficiency
  • Has a prosthetic aortic valve or a mechanical mitral valve replacement
  • Has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses
  • Cancer, with the following exceptions
    • In-situ non-melanoma skin cancer or in-situ cervical cancer
    • Has been cancer free for ≥ 5 years as determined by oncologist
  • Prior history of stem cell transplant for cancer, no matter how long they have been cancer-free
  • History of leukemia or other bone marrow disease
  • Has sickle cell disease or sickle cell trait
  • Proliferative retinopathy
  • Hb A1c > 9%
  • Has platelet counts >10% above the upper limit of normal (ULN) or platelet counts < 70,000
  • Has a hematocrit < 30% prior to potential study enrollment
  • Has a serum creatinine > 2.5 mg/dL prior to potential study enrollment
  • Tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant
  • Has a known contraindication to Neupogen (filgrastim) or G-CSF
  • Was previously enrolled in an active treatment group of cell therapy trials for cardiovascular disease including any phase of CD34+ stem cell trials
  • Left ventricular thickness of < 7 mm in the target areas of injection as measured during a 2-D echocardiogram
  • Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection
  • Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy
  • Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN
  • Any previous transplant requiring immunosuppression
  • Disease state requiring chronic immunosuppression

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

F Fortuin, M.D.

Closed for enrollment

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CLS-20308032

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