Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Stem Cell Therapy; Control (plasma)
Intervention description: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.; Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: stem cell; autologous; ischemia

Summary:

      Recent studies have suggested that it may be possible to grow new blood vessels
      (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One
      theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may
      stimulate the growth of new vessels. After a bone marrow procedure, the special cells are
      separated and then injected back into the heart around the area of damage with a special
      guidance and injection system.

      Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be
      consented to the study and extensive baseline testing will be completed at St. Luke's
      Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has
      his/her own bone marrow harvested and later injected, if randomized to receive active
      treatment. The day after the bone marrow harvest, the patient is taken to the cardiac
      catheterization lab where NOGA mapping is performed and the processed cells or placebo are
      injected under electromechanical guidance into the affected areas of the left ventricle. The
      patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4,
      and months 3 and 6, and at one year unless there is a crossover and then he/she begins
      baseline again at 6 months and follow-up for one more year. Follow-up testing, including
      quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Canadian cardiovascular (CV) Class II-IV angina and/or congestive heart failure (CHF)
             symptoms

          -  Ejection fraction less than or equal to 45%

          -  Reversible perfusion defect on single photon emission computed tomography (SPECT)

          -  Coronary artery disease (CAD) unable to be corrected by surgery (bypass) or
             intervention (stent)

          -  Able to walk on treadmill

          -  Hemodynamically stable

        Exclusion Criteria:

          -  Age less than 18 or greater than 70

          -  Atrial fibrillation

          -  Severe valve disease

          -  History of cancer in last 5 years

          -  HIV positive; hepatitis B or C positive.

          -  Left ventricular wall thickness less than 8 mm

          -  Recent heart attack within the last 30 days