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

Last updated: November 29, 2018
Sponsor: Caladrius Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Atherosclerosis

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01508910
901001
RENEW Study
  • Ages 21-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Male or female participants who are 21 to 80 years of age at the time of signing theinformed consent.

  • Participants with Canadian Cardiovascular Society (CCS) class III or IV chronicrefractory angina.

  • Participants without control of their angina symptoms in spite of maximal tolerateddoses of anti-angina drugs. Participants must be on optimal therapy for their anginaand must have been on a stable anti-anginal medication regimen for at least 4 weeksbefore signing the informed consent form.

  • Participants with obstructive coronary disease unsuitable for conventionalrevascularization due to unsuitable anatomy or comorbidity as determined at the siteand 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 treadmillwithin 3 weeks of randomization.

  • If female of childbearing potential, subject must not be pregnant and agree to employadequate birth control measures for the duration of the study.

Exclusion

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 cardiacresynchronization therapy (CRT) for heart failure within 180 days of potential studyenrollment.

  • Participant has documented stroke or transient ischemic attacks (TIAs) within 60 daysof potential study enrollment.

  • Participant has a history of moderate to severe aortic stenosis; or severe aorticinsufficiency; 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 toless 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 notexcluded.

  • Participants that have been cancer free for >= 5 years as determined by theironcologist are not excluded. Subjects with a prior history of stem celltransplant 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 plateletcounts < 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 chronicimmunosuppressive 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 therapytrials 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 measuredby during a 2-D echocardiogram (ECHO).

  • Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that wouldprohibit 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.

Study Design

Total Participants: 291
Study Start date:
April 01, 2012
Estimated Completion Date:
November 30, 2015

Connect with a study center

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • St. Michael´s Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Gilbert, Arizona
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • La Jolla, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Oxnard, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • Stanford, California
    United States

    Site Not Available

  • Boynton Beach, Florida
    United States

    Site Not Available

  • Daytona Beach, Florida
    United States

    Site Not Available

  • Gainesville, Florida
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • Tampa, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Augusta, Georgia
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Iowa City, Iowa
    United States

    Site Not Available

  • Louisville, Kentucky
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Saginaw, Michigan
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Haddon Heights, New Jersey
    United States

    Site Not Available

  • Newark, New Jersey
    United States

    Site Not Available

  • University of Buffalo

    Buffalo, New York 14214
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • Durham, North Carolina
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Germantown, Tennessee
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

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