Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395811
Recruitment Status : Unknown
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2006
Last Update Posted : October 29, 2008
Information provided by:
China National Center for Cardiovascular Diseases

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).

Condition or disease Intervention/treatment Phase
Coronary Disease Myocardial Infarction Procedure: Bone Marrow Stem Cell Therapy combined CABG Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2007
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Bone Marrow Stem Cell Therapy combined CABG
    Bone Marrow Stem Cell inject into myocardium

Primary Outcome Measures :
  1. Changes in left ventricular ejection fraction from baseline to 6 months' follow-up [ Time Frame: 3 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395811

Layout table for location information
Fuwai cardiovascular disease hospital
Beijing, China, 100037
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Layout table for investigator information
Study Director: Hu shengshou National center for cardiovascular disease ,china

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: China National Center for Cardiovascular Diseases Identifier: NCT00395811    
Other Study ID Numbers: NCCD200601
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008
Keywords provided by China National Center for Cardiovascular Diseases:
Myocardial Infarction
stem cell therapy
Coronary Artery Bypass Grafting
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Coronary Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases