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

Lisata Therapeutics, Inc.0 sites291 target enrollmentApril 2012

ConditionsChronic Myocardial Ischemia Refractory Angina Pectoris Advanced Coronary Heart Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Myocardial Ischemia
Sponsor: Lisata Therapeutics, Inc.
Enrollment: 291
Primary Endpoint: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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 with refractory angina and chronic myocardial ischemia.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

November 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lisata Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol

Time Frame: Baseline and 12 month visit

Baseline (BL) is the average of the two total exercise times measured during the screening period.

Secondary Outcomes

Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period(From randomization until the end of the 24 month follow-up period)
Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit(Baseline and 12 month visit)
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit(Baseline and 6 month visit)
Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit(6 month visit)
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period(From randomization until the end of the 24 month follow-up period)