Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina (RENEW)
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ClinicalTrials.gov Identifier: NCT01508910 |
Recruitment Status
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Completed
First Posted
: January 12, 2012
Results First Posted
: February 15, 2017
Last Update Posted
: October 23, 2017
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Sponsor:
Baxalta now part of Shire
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )
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Tracking Information | ||||
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First Submitted Date ICMJE | January 10, 2012 | |||
First Posted Date ICMJE | January 12, 2012 | |||
Results First Submitted Date | December 22, 2016 | |||
Results First Posted Date | February 15, 2017 | |||
Last Update Posted Date | October 23, 2017 | |||
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 |
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.
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Original Primary Outcome Measures ICMJE |
Change from baseline in total exercise time on EET (exercise tolerance test) using the Modified Bruce Protocol [ Time Frame: 12 months ] | |||
Change History | Complete list of historical versions of study NCT01508910 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | 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 | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
291 | |||
Original Estimated Enrollment ICMJE |
444 | |||
Actual Study Completion Date | November 2015 | |||
Actual Primary Completion Date | November 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | 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: Baxter Healthcare Corporation ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Shire ( Baxalta now part of Shire ) | |||
Study Sponsor ICMJE | Baxalta now part of Shire | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Shire | |||
Verification Date | December 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |