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 Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects With Refractory Angina Pectoris and Chronic Myocardial Ischemia
Phoenix/Scottsdale, Ariz., Jacksonville, Fla., Rochester, Minn.
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
- 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.
- 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.