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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT00395811
First received: November 1, 2006
Last updated: October 28, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Coronary Disease
Myocardial Infarction
Procedure: Bone Marrow Stem Cell Therapy combined CABG
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • Changes in left ventricular ejection fraction from baseline to 6 months' follow-up [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bone Marrow Stem Cell Therapy combined CABG
    Bone Marrow Stem Cell inject into myocardium
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395811

Locations
China
Fuwai cardiovascular disease hospital
Beijing, China, 100037
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Study Director: Hu shengshou National center for cardiovascular disease ,china
  More Information

No publications provided by China National Center for Cardiovascular Diseases

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT00395811     History of Changes
Other Study ID Numbers: NCCD200601
Study First Received: November 1, 2006
Last Updated: October 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by China National Center for Cardiovascular Diseases:
Myocardial Infarction
stem cell therapy
Coronary Artery Bypass Grafting

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014