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Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684060
First Posted: May 26, 2008
Last Update Posted: July 10, 2015
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
Results First Submitted: April 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Left Ventricular Dysfunction
Interventions: Biological: Adult stem cells
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment took place at five Network centers and their associated satellite facilities between July 8, 2008 and February 28, 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Participant Flow:   Overall Study
    Stem Cell Arm   Placebo Arm
STARTED   58   29 
COMPLETED   55   26 
NOT COMPLETED   3   3 
Lost to Follow-up                1                0 
New stenosis identified                1                0 
Unable to collect MRI                1                2 
Death                0                1 



  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.
No text entered.

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Total Total of all reporting groups

Baseline Measures
   Stem Cell Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   29   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (11)   54.6  (11)   57  (11) 
Gender 
[Units: Participants]
     
Female   12   3   15 
Male   46   26   72 
Region of Enrollment 
[Units: Participants]
     
United States   58   29   87 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Global Left Ventricular Function   [ Time Frame: Measured at Baseline and Month 6 ]

2.  Primary:   Regional Left Ventricular Function (Infarct Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]

3.  Primary:   Regional Left Ventricular Function (Border Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]

4.  Secondary:   Combined Endpoint   [ Time Frame: Measured at Baseline and Month 6 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Combined Endpoint
Measure Description Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure. This is measured as the number of events by treatment group over the 6 month follow up period.
Time Frame Measured at Baseline and Month 6  

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.
All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Measured Values
   Stem Cell Arm   Placebo Arm 
Participants Analyzed 
[Units: Participants]
 58   29 
Combined Endpoint 
[Units: Events]
 3   4 


Statistical Analysis 1 for Combined Endpoint
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] <0.05
Odds Ratio (OR) [5] 0.30
95% Confidence Interval 0.08 to 1.17
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  comparison of the proportion of events in patients in the active group to those in patients in the control group
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Secondary:   Left Ventricular Mass   [ Time Frame: Measured at Baseline and Month 6 ]

6.  Secondary:   End Diastolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]

7.  Secondary:   End Systolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]

8.  Secondary:   Infarct Volume   [ Time Frame: Measured at Baseline and Month 6 ]


  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
Lack of in-vivo testing of cell product. While there are several different approaches to measure myocardial strain (myocardial tagging, DENSE, etc.), these were not employed in this study due to the need for specialized expertise at each site.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
phone: 713-500-9518
e-mail: Lemmoye@msn.com


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

Responsible Party: Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00684060     History of Changes
Other Study ID Numbers: 578
1U01HL087318 ( U.S. NIH Grant/Contract )
1 U01-HL-087318-01 (Project 2)
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: April 9, 2012
Results First Posted: May 4, 2012
Last Update Posted: July 10, 2015