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Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

Primary Purpose

Coronary Disease, Myocardial Infarction

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Bone Marrow Stem Cell Therapy combined CABG

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Myocardial Infarction, stem cell therapy, Coronary Artery Bypass Grafting

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with coronary disease undergoing CABG.
At least 3 months since last episode of myocardial infarction
Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
Reversible myocardial ischemia as revealed by SPECT. ejection fraction >=40% <=50%. Age >=18 years and <=70 Patients who can give informed consent themselves in writing.
Negative pregnancy test (in women with childbearing potential).

Exclusion Criteria:

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

Sustained ventricular tachycardia in a 24-hour ECG.
Chronic atrial fibrillation.
Less than 3 months since last episode of cerebral infarction.
Patients with a malignant tumor*.
Patients with chronic rheumatoid arthritis.
Patients with a history of severe allergic reactions.
Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
Patients currently suffering from or having a history of interstitial pneumonitis.
Leukocytes less than 4,000/µL or exceeding 10,000/µL.
Platelets less than 100,000/µL.
Hemoglobin less than 10 g/dL.
AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
Patients for whom it is impossible to perform both cardiac MRI
Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Sites / Locations

Fuwai cardiovascular disease hospital

Outcomes

Primary Outcome Measures

Changes in left ventricular ejection fraction from baseline to 6 months' follow-up

Secondary Outcome Measures

Full Information

NCT ID

NCT00395811

First Posted

November 1, 2006

Last Updated

October 28, 2008

Sponsor

China National Center for Cardiovascular Diseases

1. Study Identification

Unique Protocol Identification Number

NCT00395811

Brief Title

Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

April 2009 (Anticipated)

Study Completion Date

June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

China National Center for Cardiovascular Diseases

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with myocardial infarction. 50 patients with stable left ventricle function will - with six months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories and Coronary Artery Bypass Graft (CABG).

Detailed Description

This research study is being performed to find out more information about the safety and efficacy of autologous bone marrow stem cells transplantation. In patients with myocardial infarction, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The researchers are trying to find out if the transplantation of these stem cell can make a change in the functioning of these areas of the heart muscle. Patients between 18 and 70 years of age who received autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study. These patients receive autologous bone marrow cells transplantation intracoronary undergoing Coronary Artery Bypass Graft. The objective evaluations will be performed at baseline and during 6 months follow-up. Heart function tests may include the following: Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine. 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. 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. MRI evaluates function of the heart chambers the beating motion of the muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease, Myocardial Infarction

Keywords

Myocardial Infarction, stem cell therapy, Coronary Artery Bypass Grafting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Bone Marrow Stem Cell Therapy combined CABG

Intervention Description

Bone Marrow Stem Cell inject into myocardium

Primary Outcome Measure Information:

Title

Changes in left ventricular ejection fraction from baseline to 6 months' follow-up

Time Frame

3 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with coronary disease undergoing CABG. At least 3 months since last episode of myocardial infarction Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography. Reversible myocardial ischemia as revealed by SPECT. ejection fraction >=40% <=50%. Age >=18 years and <=70 Patients who can give informed consent themselves in writing. Negative pregnancy test (in women with childbearing potential). Exclusion Criteria: Any one of the following exclusion criteria is sufficient to disqualify a patient from the study. Sustained ventricular tachycardia in a 24-hour ECG. Chronic atrial fibrillation. Less than 3 months since last episode of cerebral infarction. Patients with a malignant tumor*. Patients with chronic rheumatoid arthritis. Patients with a history of severe allergic reactions. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes). Patients currently suffering from or having a history of interstitial pneumonitis. Leukocytes less than 4,000/µL or exceeding 10,000/µL. Platelets less than 100,000/µL. Hemoglobin less than 10 g/dL. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L. Patients for whom it is impossible to perform both cardiac MRI Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hu shengshou

Organizational Affiliation

National center for cardiovascular disease ,china

Official's Role

Study Director

Facility Information:

Facility Name

Fuwai cardiovascular disease hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

21658561

Citation

Hu S, Liu S, Zheng Z, Yuan X, Li L, Lu M, Shen R, Duan F, Zhang X, Li J, Liu X, Song Y, Wang W, Zhao S, He Z, Zhang H, Yang K, Feng W, Wang X. Isolated coronary artery bypass graft combined with bone marrow mononuclear cells delivered through a graft vessel for patients with previous myocardial infarction and chronic heart failure: a single-center, randomized, double-blind, placebo-controlled clinical trial. J Am Coll Cardiol. 2011 Jun 14;57(24):2409-15. doi: 10.1016/j.jacc.2011.01.037.

Results Reference

derived

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Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

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