Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction (STEM-AMI)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Completed; Phase 2

Conditions: Stem Cell Transplantation; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Infarction

Treatments: Drug: Atorvastatin and mononuclear cells transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00979758

Fuwai Hospital 2009

Details and patient eligibility

About

The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after myocardial infarction who underwent intracoronary transfer of autologous bone marrow cells.

Full description

The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells. autologous bone marrow stem cells transplantation. Patients between 30 and 80 years of age who receive autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. These patients receive autologous bone marrow cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.

Heart function tests may include the following:

1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
3. Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
4. MRI evaluates function of the heart chambers the beating motion of the muscle.

Enrollment: 100 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with coronary disease undergoing PCI.
2. At most 2 months since last episode of ST-elevation myocardial infarction.
3. Left ventricular ejection fraction >=20% <=45% based on coronary angiography or echocardiography.

Exclusion criteria

Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.

1. Patients with non-ST-elevation myocardial infarction.
2. Patients with normal left ventricular function.
3. Patients with mechanical complications of myocardial infarction.
4. Patients with a malignant tumor.
5. Patients with infection disease.
6. Less than 6 months since last episode of stroke.
7. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
8. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
9. Leukocytes less than 4,000/µL or exceeding 10,000/µL.
10. Platelets less than 100,000/µL.
11. Hemoglobin less than 10 g/dL.
12. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
13. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

100 participants in 4 patient groups, including a placebo group

Atorvastatin

Sham Comparator group

Description:

Atorvastatin routine dose

Treatment:

Drug: Atorvastatin and mononuclear cells transplantation

Intensive Atorvastatin

Placebo Comparator group

Description:

Atorvastatin Intensive dose

Treatment:

Drug: Atorvastatin and mononuclear cells transplantation

Atorvastatin+Transplantation

Active Comparator group

Description:

Atorvastatin routine dose+ Mononuclear cells Transplantation

Treatment:

Drug: Atorvastatin and mononuclear cells transplantation

Intensive Atorvastatin+Transplantation

Experimental group

Description:

Atorvastatin intensive dose+ Mononuclear cells Transplantation

Treatment:

Drug: Atorvastatin and mononuclear cells transplantation