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Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01267331
Recruitment Status : Unknown
Verified December 2010 by Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2010
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
Chinese PLA General Hospital

Study Description
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Brief Summary:
This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.

Condition or disease Intervention/treatment Phase
Old Myocardial Infarction Chronic Myocardial Ischemia Left Ventricular Dysfunction Procedure: bone marrow mononuclear cells injection Procedure: placebo intramyocardial injection Phase 1 Phase 2

Detailed Description:

Severe ischemic heart disease remains a clinical challenge; many patients have undergone surgical myocardial revascularization procedures, but still remain symptomatic despite optimal medical therapy. Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for surgical treatment in patients with severe, chronic ischemic heart disease.

This research study is being performed to find out more information about the safety, feasibility, and efficacy of direct intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG). The heart function evaluations will be performed by electrocardiogram, echocardiogram, and cMRI at baseline and during 6 months follow-up.

The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), global and cardiovascular mortality, and major adverse cardiac events after undergoing coronary artery bypass surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Prospective,Randomized, Placebo-Controlled Study of Intramyocardial Injection of Autologous Bone-Marrow Mononuclear Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: stem cells injection
Direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG
 Procedure: bone marrow mononuclear cells injection
Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.
Other Name: autologous bone marrow mononuclear cells
Placebo Comparator: palcebo intramyocardial injection
Direct intramyocardial injection of placebo containing saline and 5% human serum albumin during CABG.
 Procedure: placebo intramyocardial injection
Participants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG.
Other Name: palcebo


Outcome Measures
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Primary Outcome Measures :
  1. major adverse cardiac events [ Time Frame: 6 months ]
    Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery


Secondary Outcome Measures :
  1. left ventricular function [ Time Frame: 6 months ]
    Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 75 years.
  2. Scheduled to undergo CABG.
  3. At least 3 months since last episode of myocardial infarction.
  4. Echocardiogram-assessed LVEF between 15 and 40% (Simpson's rule).
  5. Abnormal wall motion of at least one segment due to prior myocardial infarction shown by echocardiography or left ventriculography.
  6. Abnormal myocardial perfusion in infarcted area by SPECT.
  7. Willingness to participate and ability to provide written informed consent.

Exclusion Criteria:

  1. Contraindications to magnetic resonance imaging.
  2. Need for urgent or emergent revascularization.
  3. Severe valvular heart disease.
  4. Confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
  5. Prior cardiac surgery.
  6. Stroke within 3 months prior to CABG.
  7. Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
  8. Severe chronic renal insufficiency (serum creatinine ≥ 200 mmol/dl or need for dialysis), liver disease, (diagnosis of cirrhosis, chronic hepatitis, or elevation of serum transaminases ≥3 times the upper limit of normal), cerebrovascular disease requiring concomitant carotid endarterectomy, peripheral arterial disease (claudication as the primary factor limiting activity), active non-dermatological malignancy requiring on-going treatment, or any other condition that would place the patient at increased risk for complications in the judgment of the attending cardiologist or cardiac surgeon
  9. Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
  10. Active infection, with a temperature greater than 37.5°C within 48 hrs prior to surgery and an unexplained white blood cell count in excess of 10,000/mm3
  11. Significant cognitive impairment.
  12. Any condition associated with a life expectancy of less than 6 months.
  13. Participation in other studies.
  14. Positive laboratory test results for HIV, HBC, and HCV.
  15. Pregnant woman.
  16. Inability or unwillingness to provide written informed consent.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01267331


Contacts
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Contact: Changqing Gao, MD +8601066938035 gaochq301@yahoo.com
Contact: Lin Zhang, MD +8601066938336 drzhanglin@gmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Principal Investigator: Wang Rong, MD         
Principal Investigator: Zhang Lin, MD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Gao Changqing, MD Chinese PLA General Hospital
More Information
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Responsible Party: Gao Changqing, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01267331    
Other Study ID Numbers: 2006AA02A104
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: December 2010
Keywords provided by Chinese PLA General Hospital:
Old Myocardial Infarction
Stem Cell Therapy
Coronary Artery Bypass Grafting
Coronary Artery Disease
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ventricular Dysfunction
Ventricular Dysfunction, Left
Infarction
Ischemia
 Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases