Trial Outcomes & Findings for Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study) (NCT NCT00684021)

Results Overview

Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

Measured at Baseline and Month 6

Results posted on

2015-06-30

Participant Flow

Enrollment took place at five Network centers and their associated satellite facilities between July 2008 and November 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.

Participant milestones

Participant milestones
Measure	Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Study STARTED	43	24	36	17
Overall Study COMPLETED	41	22	34	15
Overall Study NOT COMPLETED	2	2	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Study MRI Contraindicated	1	1	1	0
Overall Study MRI not performed	0	1	1	2
Overall Study Death	1	0	0	0

Baseline Characteristics

Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Day 3 Stem Cell Arm n=43 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=24 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=36 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=17 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.	Total n=120 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 10.8 • n=5 Participants	57.0 years STANDARD_DEVIATION 12.4 • n=7 Participants	58.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	57.0 years STANDARD_DEVIATION 8.0 • n=4 Participants	56.9 years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	21 Participants n=7 Participants	31 Participants n=5 Participants	15 Participants n=4 Participants	105 Participants n=21 Participants
Region of Enrollment United States	43 participants n=5 Participants	24 participants n=7 Participants	36 participants n=5 Participants	17 participants n=4 Participants	120 participants n=21 Participants

PRIMARY outcome

Timeframe: Measured at Baseline and Month 6

Population: 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.

Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=41 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=22 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=34 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=15 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Global Left Ventricular Function	3.5 percentage of ejection fraction Standard Deviation 11.0	4.4 percentage of ejection fraction Standard Deviation 10.6	2.8 percentage of ejection fraction Standard Deviation 9.7	1.7 percentage of ejection fraction Standard Deviation 8.2

PRIMARY outcome

Timeframe: Measured at Baseline and Month 6

Population: Only participants with both baseline and 6 month MRI images available are included. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.

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.

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=41 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=22 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=34 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=15 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Regional Left Ventricular Function (Infarct Zone Wall Motion)	2.1 mm Standard Deviation 5.9	2.4 mm Standard Deviation 5.3	1.2 mm Standard Deviation 4.9	2.8 mm Standard Deviation 4.4

PRIMARY outcome

Timeframe: Measured at Baseline and Month 6

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

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.

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=41 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=22 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=34 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=15 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Regional Left Ventricular Function (Border Zone Wall Motion)	3.5 mm Standard Deviation 9.3	4.3 mm Standard Deviation 8.7	4.2 mm Standard Deviation 8.3	4.4 mm Standard Deviation 7.2

SECONDARY outcome

Timeframe: Measured from baseline to six months.

Population: All randomized patients were followed for clinical outcomes.

Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=43 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=24 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=36 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=17 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Clincal and Safety Outcomes	10 events	9 events	6 events	1 events

SECONDARY outcome

Timeframe: Measured at Baseline and Month 6

Population: 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.

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

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=40 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=22 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=33 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=13 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Left Ventricular Mass	-20.4 g Standard Deviation 22.8	-13.2 g Standard Deviation 30.6	-16.3 g Standard Deviation 16.7	-20.7 g Standard Deviation 26.9

SECONDARY outcome

Timeframe: Measured at Baseline and Month 6

Population: 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.

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

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=41 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=22 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=34 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=15 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
End Diastolic Volume Index	11.4 mL/m2 Standard Deviation 18.5	11.7 mL/m2 Standard Deviation 19.8	13.3 mL/m2 Standard Deviation 19.5	9.7 mL/m2 Standard Deviation 16.0

SECONDARY outcome

Timeframe: Measured at Baseline and Month 6

Population: 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.

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

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=41 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=22 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=34 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=15 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
End Systolic Volume Index	4.1 mL/m2 Standard Deviation 15.0	4.1 mL/m2 Standard Deviation 16.5	6.2 mL/m2 Standard Deviation 17.4	4.6 mL/m2 Standard Deviation 12.8

SECONDARY outcome

Timeframe: Measured at Baseline and Month 6

Population: 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.

Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.

Outcome measures

Outcome measures
Measure	Day 3 Stem Cell Arm n=40 Participants Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=20 Participants Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=32 Participants Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=13 Participants Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Infarct Volume	-9.7 mL Standard Deviation 18.4	-7.7 mL Standard Deviation 23.4	-13.6 mL Standard Deviation 18.8	-5.3 mL Standard Deviation 29.3

Adverse Events

Day 3 Stem Cell Arm

Serious events: 17 serious events

Other events: 10 other events

Deaths: 0 deaths

Day 3 Placebo Arm

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Day 7 Stem Cell Arm

Serious events: 11 serious events

Other events: 13 other events

Deaths: 0 deaths

Day 7 Placebo Arm

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Day 3 Stem Cell Arm n=43 participants at risk Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=24 participants at risk Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=36 participants at risk Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=17 participants at risk Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Cardiac disorders Chest Pain	18.6% 8/43 • Number of events 9 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	8.3% 2/24 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	2.8% 1/36 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Cardiac disorders Angina	4.7% 2/43 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/24 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.6% 2/36 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Cardiac disorders Heart Failure	9.3% 4/43 • Number of events 4 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	4.2% 1/24 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/36 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Cardiac disorders New/Worsening Thrombus	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	8.3% 2/24 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	13.9% 5/36 • Number of events 5 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.9% 1/17 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Cardiac disorders Coronary Artery Disease	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/24 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.6% 2/36 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Cardiac disorders Cardiomyopathy	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	4.2% 1/24 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	2.8% 1/36 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.9% 1/17 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)

Other adverse events

Other adverse events
Measure	Day 3 Stem Cell Arm n=43 participants at risk Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).	Day 3 Placebo Arm n=24 participants at risk Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.	Day 7 Stem Cell Arm n=36 participants at risk Participants will receive active adult stem cell infusion 7 days after PCI.	Day 7 Placebo Arm n=17 participants at risk Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Cardiac disorders Groin bruising/bleeding	11.6% 5/43 • Number of events 6 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	12.5% 3/24 • Number of events 3 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	11.1% 4/36 • Number of events 6 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	23.5% 4/17 • Number of events 5 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Respiratory, thoracic and mediastinal disorders Bronchitis	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/24 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/36 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.9% 1/17 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Cardiac disorders Thrombus	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	4.2% 1/24 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	8.3% 3/36 • Number of events 3 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Blood and lymphatic system disorders Anemia	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/24 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/36 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.9% 1/17 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Nervous system disorders Syncope	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/24 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	5.6% 2/36 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
General disorders Malaise	2.3% 1/43 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	8.3% 2/24 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	11.1% 4/36 • Number of events 4 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)	0.00% 0/17 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)

Additional Information

Lemuel Moye, MD, PhD

UT-Houston School of Public Health

Phone: 713-500-9518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place