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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)

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ClinicalTrials.gov Identifier: NCT00684060
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : May 4, 2012
Last Update Posted : July 10, 2015
Sponsor:
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

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
Enrollment 87
Recruitment Details 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  
Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI). Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Period Title: Overall Study
Started 58 29
Completed 55 26
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             1             0
New stenosis identified             1             0
Unable to collect MRI             1             2
Death             0             1
Arm/Group Title Stem Cell Arm Placebo Arm Total
Hide Arm/Group Description Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI). Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI. Total of all reporting groups
Overall Number of Baseline Participants 58 29 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 29 participants 87 participants
57.6  (11) 54.6  (11) 57  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 29 participants 87 participants
Female
12
  20.7%
3
  10.3%
15
  17.2%
Male
46
  79.3%
26
  89.7%
72
  82.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 29 participants 87 participants
58 29 87
1.Primary Outcome
Title Global Left Ventricular Function
Hide Description Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in Global EF from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 55 26
Mean (Standard Deviation)
Unit of Measure: percentage of ejection fraction
0.5  (8.2) 3.6  (9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Threshold 0.05
Method t-test, 2 sided
Comments No adjustment for multiple comparisons
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-7.05 to .95
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Regional Left Ventricular Function (Infarct Zone Wall Motion)
Hide Description One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Only participants with both baseline and 6 month MRI images available are included. One patient was excluded from the analysis due to incomplete signal intensity enhancement data.

Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 55 25
Mean (Standard Deviation)
Unit of Measure: mm
0.3  (4.3) 1.0  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Unadjusted
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.8 to 1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.4
Estimation Comments [Not Specified]
3.Primary Outcome
Title Regional Left Ventricular Function (Border Zone Wall Motion)
Hide Description Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4).

Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 53 23
Mean (Standard Deviation)
Unit of Measure: mm
0.5  (7.2) 3.2  (6.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval 95%
-6.0 to 0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Combined Endpoint
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.
Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 58 29
Measure Type: Number
Unit of Measure: events
3 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments comparison of the proportion of events in patients in the active group to those in patients in the control group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.30
Confidence Interval 95%
0.08 to 1.17
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Left Ventricular Mass
Hide Description Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.)
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in LV mass from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 55 26
Mean (Standard Deviation)
Unit of Measure: g
-12.0  (18.1) -10.8  (15.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in the active group minus change in global LVEF in the control group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-9.3 to 6.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 17.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title End Diastolic Volume Index
Hide Description Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in LV end diastolic index from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 55 26
Mean (Standard Deviation)
Unit of Measure: mL/m2
3.4  (23.4) 2.7  (18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in the active group minus change in global LVEF in the control group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-9.5 to 10.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title End Systolic Volume Index
Hide Description Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in LV end systolic volume index from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 55 26
Mean (Standard Deviation)
Unit of Measure: mL/m2
0.2  (14.0) -2.3  (14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in the active group minus change in the control group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-4.1 to 9.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 14.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Infarct Volume
Hide Description Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in infarct volume from baseline to six months.

Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description:
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Overall Number of Participants Analyzed 55 25
Mean (Standard Deviation)
Unit of Measure: mL
-3.5  (19.0) -2.0  (14.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stem Cell Arm, Placebo Arm
Comments Comparison of change in the active group minus change in the control group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.5
Confidence Interval 95%
-9.9 to 6.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 17.7
Estimation Comments [Not Specified]
Time Frame Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stem Cell Arm Placebo Arm
Hide Arm/Group Description Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI). Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
All-Cause Mortality
Stem Cell Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stem Cell Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/58 (13.79%)      14/29 (48.28%)    
Cardiac disorders     
Chest Pain   6/58 (10.34%)  9 8/29 (27.59%)  8
Heart Failure   2/58 (3.45%)  2 2/29 (6.90%)  2
Left Ventricular Thrombus   0/58 (0.00%)  0 2/29 (6.90%)  2
Tachycardia   0/58 (0.00%)  0 2/29 (6.90%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stem Cell Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/58 (22.41%)      14/29 (48.28%)    
Blood and lymphatic system disorders     
Anemia   4/58 (6.90%)  4 2/29 (6.90%)  2
Cardiac disorders     
Chest Pain   4/58 (6.90%)  5 4/29 (13.79%)  4
Tachycardia   0/58 (0.00%)  0 3/29 (10.34%)  3
Syncope   1/58 (1.72%)  1 2/29 (6.90%)  2
Gastrointestinal disorders     
Nausea   3/58 (5.17%)  3 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchitis   1/58 (1.72%)  1 3/29 (10.34%)  3
Indicates events were collected by systematic assessment
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.
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
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