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

Phase 2

Completed

Conditions: Left Ventricular Dysfunction

Interventions: Biological: Adult stem cells
Biological: Placebo

Registration Number: NCT00684021

Lead Sponsor: The University of Texas Health Science Center, Houston

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Adult stem cells	Participants will receive active adult stem cell infusion 7 days after PCI.
3	Placebo	Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.
4	Placebo	Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1	Adult stem cells	Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Infarct Volume	Measured at Baseline and Month 6	Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.
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
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.
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.

Trial Locations

Locations (5): Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Texas Heart Institute
🇺🇸
Houston, Texas, United States
Minneapolis Heart Institute Foundation
🇺🇸
Minneapolis, Minnesota, United States
University of Florida-Department of Medicine
🇺🇸
Gainesville, Florida, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States