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Trial record 1 of 1 for:    NCT01508910
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Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina (RENEW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01508910
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 15, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE January 10, 2012
First Posted Date  ICMJE January 12, 2012
Results First Submitted Date  ICMJE December 22, 2016
Results First Posted Date  ICMJE February 15, 2017
Last Update Posted Date December 19, 2018
Study Start Date  ICMJE April 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
Change from baseline in total exercise time on EET (exercise tolerance test) using the Modified Bruce Protocol [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit [ Time Frame: Baseline and 12 month visit ]
    Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.
  • Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit [ Time Frame: Baseline and 6 month visit ]
    Baseline (BL) is the average of the two total exercise times measured during the screening period.
  • Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit [ Time Frame: 6 month visit ]
  • Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period [ Time Frame: From randomization until the end of the 24 month follow-up period ]
    Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee. The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke.
  • Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period [ Time Frame: From randomization until the end of the 24 month follow-up period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
  • Angina frequency (episodes per week) [ Time Frame: 12 months ]
    Subjects will self-report angina episodes utilizing an electronic diary for 4 weeks at baseline and before the 3, 6 and 12 month follow-up visit.
  • Change from baseline in total exercise time on ETT at the 6 month follow-up timepoint [ Time Frame: 6 months ]
  • Angina frequency (episodes per week) at the 6 month follow-up timepoint [ Time Frame: 6 months ]
  • Incidence of major adverse cardiac events and other serious adverse events in all subjects [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Myocardial Ischemia
  • Refractory Angina Pectoris
  • Advanced Coronary Heart Disease
Intervention  ICMJE
  • Biological: Auto-CD34+ cells
    10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
  • Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
    10 intramyocardial injections of 0.2 mL per injection site of placebo
  • Other: Standard of care
    Standard of care for refractory angina
Study Arms  ICMJE
  • Experimental: Treatment Arm
    Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
    Intervention: Biological: Auto-CD34+ cells
  • Placebo Comparator: Active Control Arm
    Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
    Intervention: Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
  • Unblinded Standard of Care (SOC) Arm
    No study-related procedures will be performed.
    Intervention: Other: Standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2013)
291
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2012)
444
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main 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.

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01508910
Other Study ID Numbers  ICMJE 901001
RENEW Study ( Other Identifier: Caladrius Biosciences, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Caladrius Biosciences, Inc.
Study Sponsor  ICMJE Caladrius Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Caladrius Study Director Caladrius Biosciences
PRS Account Caladrius Biosciences, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP