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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT00684060
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 87
• Locations: 5
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 17.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI).

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Dysfunction	Biological: Adult stem cells; Biological: Placebo	Phase 2

Detailed Description

Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blocked almost completely and the heart muscle in that area can suffer permanent injury or death. Although a PCI can be used to open up the blocked artery and restore blood flow to the heart muscle, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function after a heart attack. These specialized cells may have the ability to promote blood vessel growth, prevent cell death, and transform themselves into a number of tissues, including muscle. After an acute heart attack, a remodeling process is initiated in the heart in an attempt to compensate for damaged areas. Consequently, the condition of the heart muscle several weeks after a heart attack may differ considerably from the heart's condition during the acute setting. For some patients, delaying the delivery of the stem cells until 2 to 3 weeks after a heart attack may be better than initiating treatment during the acute phase. This study will evaluate the safety and effectiveness of placing adult stem cells into injured heart muscle 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a PCI.

Participation in this study will last 24 months. All participants will first undergo baseline assessments that will include a medical history, a physical exam, an electrocardiogram (ECG), blood draws, an echocardiogram, and a magnetic resonance imaging (MRI) test. Participants will then be assigned randomly to receive stem cells or placebo between 2 and 3 weeks after their heart attack. The morning of the stem cell or placebo infusion, participants will undergo a blood draw and a bone marrow aspiration procedure of the hip bone to collect the stem cells. Later the same day, either stem cells or placebo will be infused through a catheter and into the damaged area of the heart.

For the first 24 hours after the infusion, participants will be asked to wear a small ECG machine called a Holter monitor. Participants will also be asked to record their temperature twice a day for a month after the infusion. Participants will return for follow-up visits at Months 1, 3, 6, 12, and 24 and will repeat many of the baseline assessments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).	Biological: Adult stem cells; One time infusion of approximately 150 million total nucleated cells (TNC) in 30 ml of 5% HSA/saline solution; Other Names: Adult autologous stem cells Bone marrow mononucleated cells
Placebo Comparator: 2 Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.	Biological: Placebo; One time infusion of 30 ml of HSA (5%); Other Names: Human serum albumin HSA

Outcome Measures

Primary Outcome Measures

1. Global Left Ventricular Function [Measured at Baseline and Month 6]

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

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

   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.

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

   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.

Secondary Outcome Measures

1. Combined Endpoint [Measured at Baseline and Month 6]

   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.

2. Left Ventricular Mass [Measured at Baseline and Month 6]

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

3. End Diastolic Volume Index [Measured at Baseline and Month 6]

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

4. End Systolic Volume Index [Measured at Baseline and Month 6]

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

5. Infarct Volume [Measured at Baseline and Month 6]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Patients at least 21 years of age.

2. Patients with first acute MI and subsequent successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter occurring two to three weeks before recruitment.

3. No contraindications to undergoing cell therapy procedure within two to three weeks following AMI and PCI.

4. Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications.

5. Ejection fraction following reperfusion with PCI <=45% as assessed by echocardiography.

6. Consent to protocol and agree to comply with all follow-up visits and studies.

7. Women of child bearing potential willing to use an active form of birth control.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following conditions:

1. History of sustained ventricular arrhythmias not related to their AMI (evidenced by previous holter monitoring and/or medication history for sustained ventricular arrhythmias in patient's medical chart).

2. Require CABG or PCI due to the presence of residual coronary stenosis >70% luminal obstruction in the non-infarct related vessel (Additional PCI of non-culprit vessels may be performed prior to enrollment).

3. History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ.

4. History of chronic anemia (hemoglobin (Hb) <9.0 mg/dl).

5. History of thrombocytosis (platelets >500k).

6. History of thrombocytopenia in the absence of recent evidence that platelet counts are normal

7. Known history of elevated INR (PT) or PTT.

8. Life expectancy less than one year.

9. History of untreated alcohol or drug abuse.

10. Currently enrolled in another Investigational drug or device trial

11. Previous CABG.

12. Previous MI resulting in LV dysfunction (LVEF <55%)

13. History of stroke or transient ischemic attack (TIA) within the past six months.

14. History of severe valvular heart disease (aortic valve area <1.0 cm2 or >3+ mitral regurgitation).

15. Pregnancy or breast feeding

16. Subjects with a known history of HIV, or has active hepatitis B, active hepatitis C, or active tuberculosis (TB)

17. Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.

18. Contraindications to cMRI.

19. Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values.

20. Women child bearing potential not willing to practice an active form of birth control.

21. Chronic liver disease that might interfere with survival or treatment with cell therapy.

22. Chronic renal insufficiency as defined by a creatinine ≥2.0 mg/dL or requires chronic dialysis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida - Department of Medicine	Gainesville	Florida	United States	32610
2	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
3	Cleveland Clinic	Cleveland	Ohio	United States	44195
4	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
5	Texas Heart Institute	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Study Chair: Robert Simari, MD, Cardiovascular Cell Therapy Research Network

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information on this study at the Cardiovascular Cell Therapy Research Network (CCTRN)
• Click here for the National Heart, Lung, and Blood Institute

Publications

• Gee AP, Richman S, Durett A, McKenna D, Traverse J, Henry T, Fisk D, Pepine C, Bloom J, Willerson J, Prater K, Zhao D, Koç JR, Ellis S, Taylor D, Cogle C, Moyé L, Simari R, Skarlatos S. Multicenter cell processing for cardiovascular regenerative medicine applications: the Cardiovascular Cell Therapy Research Network (CCTRN) experience. Cytotherapy. 2010 Sep;12(5):684-91. doi: 10.3109/14653249.2010.487900.
• Traverse JH, Henry TD, Vaughan DE, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Simpson LM, Penn MS, Byrne BJ, Perin EC, Gee AP, Hatzopoulos AK, McKenna DH, Forder JR, Taylor DA, Cogle CR, Baraniuk S, Olson RE, Jorgenson BC, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moyè LA, Simari RD; Cardiovascular Cell Therapy Research Network. LateTIME: a phase-II, randomized, double-blinded, placebo-controlled, pilot trial evaluating the safety and effect of administration of bone marrow mononuclear cells 2 to 3 weeks after acute myocardial infarction. Tex Heart Inst J. 2010;37(4):412-20.
• Zierold C, Carlson MA, Obodo UC, Wise E, Piazza VA, Meeks MW, Vojvodic RW, Baraniuk S, Henry TD, Gee AP, Ellis SG, Moyé LA, Pepine CJ, Cogle CR, Taylor DA. Developing mechanistic insights into cardiovascular cell therapy: Cardiovascular Cell Therapy Research Network Biorepository Core Laboratory rationale. Am Heart J. 2011 Dec;162(6):973-80. doi: 10.1016/j.ahj.2011.05.024.

• Responsible Party: Dr Lemuel A Moye III, Professor - School of Public Health, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT00684060
• Other Study ID Numbers: 578; 1U01HL087318; 1 U01-HL-087318-01 (Project 2)
• First Posted: May 26, 2008
• Last Update Posted: Jul 10, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Dr Lemuel A Moye III, Professor - School of Public Health, The University of Texas Health Science Center, Houston: Acute Myocardial Infarction; Global Left Ventricular Ejection Fraction; Regional Left Ventricular Ejection Fraction; Left Ventricular Mass; Infarct Size; End Systolic Volume; End Diastolic Volume
• Additional relevant MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left

Study Results

Participant Flow

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.

Arm/Group Title	Stem Cell Arm	Placebo Arm
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

Baseline Characteristics

Arm/Group Title	Stem Cell Arm	Placebo Arm	Total
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 Participants	58	29	87
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.6 (11)	54.6 (11)	57 (11)
Sex: Female, Male (Count of Participants)
Female	12 20.7%	3 10.3%	15 17.2%
Male	46 79.3%	26 89.7%	72 82.8%
Region of Enrollment (participants) [Number]
United States	58 100%	29 100%	87 100%

Outcome Measures

1. Primary Outcome

Title	Global Left Ventricular Function
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

Outcome Measure Data

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
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.
Measure Participants	55	26
Mean (Standard Deviation) [percentage of ejection fraction]	0.5 (8.2)	3.6 (9.3)

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
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

2. Secondary Outcome

Title	Combined Endpoint
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

Outcome Measure Data

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
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.
Measure Participants	58	29
Number [events]	3	4

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.30
	Confidence Interval	() 95%; 0.08 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Left Ventricular Mass
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

Outcome Measure Data

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
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.
Measure Participants	55	26
Mean (Standard Deviation) [g]	-12.0 (18.1)	-10.8 (15.2)

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
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

4. Secondary Outcome

Title	End Diastolic Volume Index
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

Outcome Measure Data

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
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.
Measure Participants	55	26
Mean (Standard Deviation) [mL/m2]	3.4 (23.4)	2.7 (18.1)

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
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

5. Secondary Outcome

Title	End Systolic Volume Index
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

Outcome Measure Data

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
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.
Measure Participants	55	26
Mean (Standard Deviation) [mL/m2]	0.2 (14.0)	-2.3 (14.7)

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
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

6. Secondary Outcome

Title	Infarct Volume
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

Outcome Measure Data

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
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.
Measure Participants	55	25
Mean (Standard Deviation) [mL]	-3.5 (19.0)	-2.0 (14.4)

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
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

7. Primary Outcome

Title	Regional Left Ventricular Function (Infarct Zone Wall Motion)
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

Outcome Measure Data

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
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.
Measure Participants	55	25
Mean (Standard Deviation) [mm]	0.3 (4.3)	1.0 (4.5)

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Unadjusted
	Method	t-test, 2 sided
	Comments
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

8. Primary Outcome

Title	Regional Left Ventricular Function (Border Zone Wall Motion)
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

Outcome Measure Data

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
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.
Measure Participants	53	23
Mean (Standard Deviation) [mm]	0.5 (7.2)	3.2 (6.3)

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
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
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

Adverse Events

Time Frame	Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Arm/Group Title	Stem Cell Arm		Placebo Arm
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stem Cell Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/58 (13.8%)		14/29 (48.3%)
Cardiac disorders
Chest Pain	6/58 (10.3%)	9	8/29 (27.6%)	8
Heart Failure	2/58 (3.4%)	2	2/29 (6.9%)	2
Left Ventricular Thrombus	0/58 (0%)	0	2/29 (6.9%)	2
Tachycardia	0/58 (0%)	0	2/29 (6.9%)	3
Other (Not Including Serious) Adverse Events
	Stem Cell Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/58 (22.4%)		14/29 (48.3%)
Blood and lymphatic system disorders
Anemia	4/58 (6.9%)	4	2/29 (6.9%)	2
Cardiac disorders
Chest Pain	4/58 (6.9%)	5	4/29 (13.8%)	4
Tachycardia	0/58 (0%)	0	3/29 (10.3%)	3
Syncope	1/58 (1.7%)	1	2/29 (6.9%)	2
Gastrointestinal disorders
Nausea	3/58 (5.2%)	3	0/29 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchitis	1/58 (1.7%)	1	3/29 (10.3%)	3

Limitations/Caveats

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

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.