Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

Completed · Phase 1

Conditions studied: Myocardial Infarction

In brief

This research is being done because currently there is no effective way in regenerating or replacing the heart muscle that has been damaged after a heart attack. The purpose of this study is to test whether injecting cells obtained from the patient's bone marrow into the coronary artery can regenerate and replace heart tissue to strengthen heart and prevent heart from dilating and developing heart failure.

Key facts

Study ID

NCT00874354

Run by

Cedars-Sinai Medical Center

People needed

27

Starts

2005-07-01

Expected to finish

2013-06-01

Last updated by the study team

2017-02-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with acute myocardial infarction (ST elevation in at least 2 leads ≥ 0.2 mV in V1,V2 or V3 or ≥ 0.1 mV in other leads), treated by one of the following procedures:
• Acute PCI with stent implantation for acute ST elevation MI for either denovo lesions or in-stent thrombosis
• Treatment with thrombolysis followed by PCI with stent implantation.
• Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
• At the time of inclusion (≥ 1 day post PCI) patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
• Significant regional wall motion abnormality on echocardiography at the time of acute PCI (ejection fraction ≤ 50% on visual estimation).
• Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
• Age 18 - 80 Years
• Written informed consent

You may not qualify if…

• Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
• Need to acutely revascularize additional vessels, outside the infarct artery.
• Arteriovenous malformations or aneurysms
• Active infection or fever or diarrhea within last 4 weeks.
• Chronic inflammatory disease
• HIV infection or active hepatitis
• Neoplastic disease without documented remission within the past 5 years.
• Cerebrovascular insult within 3 months
• Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
• Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1.5)
• Anemia (hemoglobin < 8.5 g/dl)
• Platelet count < 100,000/µl
• Hypersplenism
• History of bleeding disorder
• Gastrointestinal bleeding within 3 months
• Major surgical procedure or trauma within 2 months
• Uncontrolled hypertension
• Pregnancy
• Mental retardation
• Previously performed stem / mononuclear cell therapy
• Participation in another clinical trial within the last 30 days

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.