Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina

Trial ID or NCT#

NCT01508910

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 21 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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.
    1. Main
Exclusion Criteria:
  1. * 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:
  2. * 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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Contact

Lauren Davis

View on ClinicalTrials.gov