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

October 28, 2008 updated by: China National Center for Cardiovascular Diseases

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Fuwai cardiovascular disease hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with coronary disease undergoing CABG.
  2. At least 3 months since last episode of myocardial infarction

  3. 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.

  4. 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in left ventricular ejection fraction from baseline to 6 months' follow-up
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Study Director: Hu shengshou, National center for cardiovascular disease ,china

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 2, 2006

First Posted (Estimate)

November 3, 2006

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 28, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCD200601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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