A Prospective, Randomized, Double-Blinded, Active-Control And Unblinded Standard Of Care (Soc) Controlled Study To Determine The Efficacy And Safety Of Targeted Intramyocardial Delivery Of G-Csf Mobilized Autologus Cd34+ Cells For The Improvement In Total Exercise Time During Standardized Exercise Testing In Subjects With Refractory Angina Pectoris And Chronic Myocardial Ischemia(Cmi)[Protocol: 901001]

Trial ID:
IRB-11-5823
Richard Schatz
The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.

Main Inclusion Criteria:

  • Male or female participants who are 21 to 80 years of age at the time of signing the informed consent.
  • Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
  • Participants without control of their angina symptoms in spite of maximal tolerated doses of anti-angina drugs. Participants must be on optimal therapy for their angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form.
  • Participants with 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.
  • Participants must have evidence of inducible myocardial ischemia.
  • Participants must experience angina episodes.
  • Participants must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization.
  • If female of childbearing potential, subject must not be pregnant and agree to employ adequate birth control measures for the duration of the study.

Main Exclusion Criteria:

  • Cardiovascular hospitalization within 60 days prior to potential study enrollment. Participant has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment.
  • Participant has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment.
  • Participant has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment.
  • Participant has a history of moderate to severe aortic stenosis; or severe aortic insufficiency; or severe mitral stenosis; or severe mitral insufficiency.
  • Participant has a prosthetic aortic valve or a mechanical mitral valve replacement.
  • Participant has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses.
  • Participants with cancer are excluded with the following exceptions:
    • Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not excluded.
    • Participants that have been cancer free for >= 5 years as determined by their oncologist are not excluded. Subjects with a prior history of stem cell transplant for cancer are excluded no matter how long they have been cancer-free.
  • Participants with a history of leukemia or other bone marrow disease.
  • Participant has sickle cell disease or sickle cell trait.
  • Participants with proliferative retinopathy.
  • Participants with Hb A1c > 9%.
  • Participant has platelet counts >10% above the upper limit of normal (ULN) or platelet counts < 70,000.
  • Participant has a hematocrit < 30% prior to potential study enrollment.
  • Participant has a serum creatinine > 2.5 mg/dL prior to potential study enrollment.
  • Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant.
  • Participant has a known contraindication to Neupogen (filgrastim) or G-CSF.
  • Participant 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 (LV) thickness of < 7 mm in the target areas of injection as measured by during a 2-D echocardiogram (ECHO).
  • 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.

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