Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
|Left Ventricular Dysfunction||Biological: Adult stem cells Biological: Placebo||Phase 2|
|Study Design:||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|
- Global Left Ventricular Function [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Combined Endpoint [ Time Frame: 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.
- Left Ventricular Mass [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Measured at Baseline and Month 6 ]Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.
|Study Start Date:||July 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
Placebo Comparator: 2
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
One time infusion of 30 ml of HSA (5%)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684060
|United States, Florida|
|University of Florida - Department of Medicine|
|Gainesville, Florida, United States, 32610|
|United States, Minnesota|
|Minneapolis Heart Institute Foundation|
|Minneapolis, Minnesota, United States, 55407|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Texas Heart Institute|
|Houston, Texas, United States, 77030|
|Study Chair:||Robert Simari, MD||Cardiovascular Cell Therapy Research Network|