Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)
Study Details
Study Description
Brief Summary
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 percutaneous coronary intervention (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. This study will evaluate the safety and effectiveness of using adult stem cells for improving heart function in people who have had a recent heart attack and a PCI.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
More than 1 million Americans suffer a heart attack each year, resulting in about a 38% mortality rate. 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. The permanent damage to the heart can lead to more severe problems, such as heart failure and irregular heartbeat, making the discovery of treatments to improve heart function after a heart attack important. 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. 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. 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 placing adult stem cells into injured heart muscle for improving heart function in people who have had a recent heart attack and a PCI. Additionally, this study will help determine the best time to insert stem cells after a heart attack.
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 either 3 or 7 days 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 following 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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 1 Participants will receive active adult stem cell infusion 3 days after 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:
|
Active Comparator: 2 Participants will receive active adult stem cell infusion 7 days after 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:
|
Placebo Comparator: 3 Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. |
Biological: Placebo
One time infusion of 30 ml of HSA (5%)
Other Names:
|
Placebo Comparator: 4 Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Biological: Placebo
One time infusion of 30 ml of HSA (5%)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
- Clincal and Safety Outcomes [Measured from baseline to six months.]
Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements
- 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.
- 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.
- 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.
- 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
Inclusion criteria
-
Patients at least 21 years of age
-
Patients with first acute MI with successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter within 24 hours of onset of symptoms.
-
No contraindications to undergoing cell therapy procedure within three to seven days following AMI and PCI.
-
Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications.
-
Ejection fraction following reperfusion with PCI <=45% as assessed by echocardiography.
-
Consent to protocol and agree to comply with all follow-up visits and studies.
-
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:
-
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).
-
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).
-
History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ.
-
History of chronic anemia (hemoglobin (Hb) <9.0 mg/dl).
-
History of thrombocytosis (platelets >500k).
-
History of thrombocytopenia in the absence of recent evidence that platelet counts are normal
-
Known history of elevated INR (PT) or PTT.
-
Life expectancy less than one year.
-
History of untreated alcohol or drug abuse.
-
Currently enrolled in another investigational drug or device trial
-
Previous CABG.
-
Previous MI resulting in LV dysfunction (LVEF <55%)
-
History of stroke or transient ischemic attack (TIA) within the past six months.
-
History of severe valvular heart disease (aortic valve area <1.0 cm2 or >3+ mitral regurgitation).
-
Pregnancy or breast feeding
-
Subjects with a known history of HIV, or has active hepatitis B,active hepatitis C, or active TB
-
Patients with active inflammatory or autoimmune disease on chronic immuno-suppressive therapy.
-
Contraindications to cMRI.
-
Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values.
-
Women child bearing potential not willing to practice an active form of birth control.
-
Chronic liver disease that might interfere with survival or treatment with cell therapy.
-
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, Piller LB, Penn MS, Byrne BJ, Perin EC, Gee AP, Hatzopoulos AK, McKenna DH, Forder JR, Taylor DA, Cogle CR, Olson RE, Jorgenson BC, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moye' LA, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction. Am Heart J. 2009 Sep;158(3):356-63. doi: 10.1016/j.ahj.2009.06.009. Epub 2009 Jul 23. Erratum in: Am Heart J. 2009 Dec;158(6):1045. Vaughn, Douglas E [corrected to Vaughan, Douglas E].
- 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.
- 579
- U01HL087318
- 1 U01-HL-087318-01 (Project 1)
Study Results
Participant Flow
Recruitment Details | 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. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Period Title: Overall Study | ||||
STARTED | 43 | 24 | 36 | 17 |
COMPLETED | 41 | 22 | 34 | 15 |
NOT COMPLETED | 2 | 2 | 2 | 2 |
Baseline Characteristics
Arm/Group Title | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm | Total |
---|---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. | Total of all reporting groups |
Overall Participants | 43 | 24 | 36 | 17 | 120 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
55.6
(10.8)
|
57.0
(12.4)
|
58.2
(11.3)
|
57.0
(8.0)
|
56.9
(10.9)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
5
11.6%
|
3
12.5%
|
5
13.9%
|
2
11.8%
|
15
12.5%
|
Male |
38
88.4%
|
21
87.5%
|
31
86.1%
|
15
88.2%
|
105
87.5%
|
Region of Enrollment (participants) [Number] | |||||
United States |
43
100%
|
24
100%
|
36
100%
|
17
100%
|
120
100%
|
Outcome Measures
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 | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 41 | 22 | 34 | 15 |
Mean (Standard Deviation) [percentage of ejection fraction] |
3.5
(11.0)
|
4.4
(10.6)
|
2.8
(9.7)
|
1.7
(8.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.959 |
Comments | ||
Method | t-test, 2 sided | |
Comments | Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -4.1 to 3.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.0 |
|
Estimation Comments |
Title | Clincal and Safety Outcomes |
---|---|
Description | Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements |
Time Frame | Measured from baseline to six months. |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients were followed for clinical outcomes. |
Arm/Group Title | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 43 | 24 | 36 | 17 |
Number [events] |
10
|
9
|
6
|
1
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.93 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
Estimated Value | 0.96 | |
Confidence Interval |
(2-Sided) 95% 0.42 to 2.23 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 40 | 22 | 33 | 13 |
Mean (Standard Deviation) [g] |
-20.4
(22.8)
|
-13.2
(30.6)
|
-16.3
(16.7)
|
-20.7
(26.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.585 |
Comments | ||
Method | Regression, Linear | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -2.6 | |
Confidence Interval |
(2-Sided) 95% -12.2 to 6.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.8 |
|
Estimation Comments |
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 | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 41 | 22 | 34 | 15 |
Mean (Standard Deviation) [mL/m2] |
11.4
(18.5)
|
11.7
(19.8)
|
13.3
(19.5)
|
9.7
(16.0)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.831 |
Comments | ||
Method | Regression, Linear | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 8.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.7 |
|
Estimation Comments |
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 | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 41 | 22 | 34 | 15 |
Mean (Standard Deviation) [mL/m2] |
4.1
(15.0)
|
4.1
(16.5)
|
6.2
(17.4)
|
4.6
(12.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.817 |
Comments | ||
Method | Regression, Linear | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -5.5 to 7.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.7 |
|
Estimation Comments |
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 | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 40 | 20 | 32 | 13 |
Mean (Standard Deviation) [mL] |
-9.7
(18.4)
|
-7.7
(23.4)
|
-13.6
(18.8)
|
-5.3
(29.3)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.272 |
Comments | ||
Method | Regression, Linear | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -4.7 | |
Confidence Interval |
(2-Sided) 95% -13.7 to 3.67 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.27 |
|
Estimation Comments |
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. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months. |
Arm/Group Title | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 41 | 22 | 34 | 15 |
Mean (Standard Deviation) [mm] |
2.1
(5.9)
|
2.4
(5.3)
|
1.2
(4.9)
|
2.8
(4.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.409 |
Comments | ||
Method | t-test, 2 sided | |
Comments | Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.1 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.02 |
Comments | ||
Method | Regression, Linear | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 100 | |
Confidence Interval |
(2-Sided) 95% 15 to 1000 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: .01 |
|
Estimation Comments |
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 |
---|
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 | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm |
---|---|---|---|---|
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. |
Measure Participants | 41 | 22 | 34 | 15 |
Mean (Standard Deviation) [mm] |
3.5
(9.3)
|
4.3
(8.7)
|
4.2
(8.3)
|
4.4
(7.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.777 |
Comments | ||
Method | t-test, 2 sided | |
Comments | Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined. | |
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 2.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.7 |
|
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) | |||||||
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Adverse Event Reporting Description | ||||||||
Arm/Group Title | Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm | ||||
Arm/Group Description | Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. | Participants will receive active adult stem cell infusion 7 days after PCI. | Participants will receive placebo infusion (5% HSA) 7 days after PCI. | ||||
All Cause Mortality |
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Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
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Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 17/43 (39.5%) | 6/24 (25%) | 11/36 (30.6%) | 2/17 (11.8%) | ||||
Cardiac disorders | ||||||||
Chest Pain | 8/43 (18.6%) | 9 | 2/24 (8.3%) | 2 | 1/36 (2.8%) | 1 | 0/17 (0%) | 0 |
Angina | 2/43 (4.7%) | 2 | 0/24 (0%) | 0 | 2/36 (5.6%) | 2 | 0/17 (0%) | 0 |
Heart Failure | 4/43 (9.3%) | 4 | 1/24 (4.2%) | 1 | 0/36 (0%) | 0 | 0/17 (0%) | 0 |
New/Worsening Thrombus | 1/43 (2.3%) | 1 | 2/24 (8.3%) | 2 | 5/36 (13.9%) | 5 | 1/17 (5.9%) | 1 |
Coronary Artery Disease | 1/43 (2.3%) | 1 | 0/24 (0%) | 0 | 2/36 (5.6%) | 2 | 0/17 (0%) | 0 |
Cardiomyopathy | 1/43 (2.3%) | 1 | 1/24 (4.2%) | 1 | 1/36 (2.8%) | 1 | 1/17 (5.9%) | 1 |
Other (Not Including Serious) Adverse Events |
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Day 3 Stem Cell Arm | Day 3 Placebo Arm | Day 7 Stem Cell Arm | Day 7 Placebo Arm | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 10/43 (23.3%) | 6/24 (25%) | 13/36 (36.1%) | 6/17 (35.3%) | ||||
Blood and lymphatic system disorders | ||||||||
Anemia | 1/43 (2.3%) | 1 | 0/24 (0%) | 0 | 0/36 (0%) | 0 | 1/17 (5.9%) | 1 |
Cardiac disorders | ||||||||
Groin bruising/bleeding | 5/43 (11.6%) | 6 | 3/24 (12.5%) | 3 | 4/36 (11.1%) | 6 | 4/17 (23.5%) | 5 |
Thrombus | 1/43 (2.3%) | 1 | 1/24 (4.2%) | 1 | 3/36 (8.3%) | 3 | 0/17 (0%) | 0 |
General disorders | ||||||||
Malaise | 1/43 (2.3%) | 1 | 2/24 (8.3%) | 2 | 4/36 (11.1%) | 4 | 0/17 (0%) | 0 |
Nervous system disorders | ||||||||
Syncope | 1/43 (2.3%) | 1 | 0/24 (0%) | 0 | 2/36 (5.6%) | 2 | 0/17 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Bronchitis | 1/43 (2.3%) | 1 | 0/24 (0%) | 0 | 0/36 (0%) | 0 | 1/17 (5.9%) | 1 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Lemuel Moye, MD, PhD |
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Organization | UT-Houston School of Public Health |
Phone | 713-500-9518 |
Lemmoye@msn.com |
- 579
- U01HL087318
- 1 U01-HL-087318-01 (Project 1)