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Trial record 1 of 1 for:    01508910
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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxalta US Inc.
ClinicalTrials.gov Identifier:
NCT01508910
First received: January 10, 2012
Last updated: December 22, 2016
Last verified: December 2016
Results First Received: December 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Myocardial Ischemia
Refractory Angina Pectoris
Advanced Coronary Heart Disease
Interventions: Biological: Auto-CD34+ cells
Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
Other: Standard of care

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study started in May 2012 and completed in November 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
291 participants provided informed consent and were screened. There were 179 screen failures. 112 participants were randomized and treated. Note that during treatment the number of arms increased from 3 to 4 to include "Not Injected" arm as 6 participants in Treatment and Active Control Arms did not have intramyocardial injections.

Reporting Groups
  Description
Treatment Arm Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
Active Control Arm Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
Unblinded Standard of Care (SOC) Arm No study-related procedures were performed.
Not Injected Arm Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.

Participant Flow for 2 periods

Period 1:   Randomization
    Treatment Arm   Active Control Arm   Unblinded Standard of Care (SOC) Arm   Not Injected Arm
STARTED   57   27   28   0 [1] 
COMPLETED   57   27   28   0 
NOT COMPLETED   0   0   0   0 
[1] Participants not randomized into Not Injected arm, but some were re-assigned here during treatment.

Period 2:   Treatment
    Treatment Arm   Active Control Arm   Unblinded Standard of Care (SOC) Arm   Not Injected Arm
STARTED   50   28   28   6 [1] 
COMPLETED   48   24   18   3 
NOT COMPLETED   2   4   10   3 
Death                2                3                2                0 
Lost to Follow-up                0                0                2                1 
Withdrawal by Subject                0                1                6                1 
Sponsor Decision                0                0                0                1 
[1] 3 moved from Treatment (Tx) to Active Control (AC) Arm; 6 in Not injected Arm(4 from Tx ; 2 from AC)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Arms for baseline characteristics based on the Safety population as randomized i.e. randomized participants prior to treatment.

Reporting Groups
  Description
Treatment Arm Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
Active Control Arm Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
Unblinded Standard of Care (SOC) Arm No study-related procedures will be performed.
Total Total of all reporting groups

Baseline Measures
   Treatment Arm   Active Control Arm   Unblinded Standard of Care (SOC) Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   27   28   112 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (8)   64  (8)   63  (10)   64  (8) 
Gender 
[Units: Participants]
Count of Participants
       
Female      10  17.5%      4  14.8%      4  14.3%      18  16.1% 
Male      47  82.5%      23  85.2%      24  85.7%      94  83.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol   [ Time Frame: Baseline and 12 month visit ]

2.  Secondary:   Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit   [ Time Frame: Baseline and 12 month visit ]

3.  Secondary:   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 ]

4.  Secondary:   Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit   [ Time Frame: 6 month visit ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated early due to business considerations. Participants in Treatment or Active Control arms who did not have injection of target cells/placebo assigned to Not Injected Arm. Not included in efficacy analysis but in safety follow-up.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Registries and Results Disclosure
Organization: Baxalta US Inc.
e-mail: ClinicalTrialsDisclosure@baxalta.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Baxalta US Inc.
ClinicalTrials.gov Identifier: NCT01508910     History of Changes
Other Study ID Numbers: 901001
RENEW Study ( Other Identifier: Baxter Healthcare Corporation )
Study First Received: January 10, 2012
Results First Received: December 22, 2016
Last Updated: December 22, 2016