Status:
COMPLETED
Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
Lead Sponsor:
Lisata Therapeutics, Inc.
Conditions:
Chronic Myocardial Ischemia
Refractory Angina Pectoris
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT01508910
Start Date
April 1 2012
End Date
November 1 2015
Last Update
December 19 2018
Active Locations (41)
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1
Birmingham, Alabama, United States
2
Gilbert, Arizona, United States
3
Phoenix, Arizona, United States
4
La Jolla, California, United States