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

Primary Purpose

Old Myocardial Infarction, Chronic Myocardial Ischemia, Left Ventricular Dysfunction

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

bone marrow mononuclear cells injection

placebo intramyocardial injection

About this trial

This is an interventional treatment trial for Old Myocardial Infarction focused on measuring Old Myocardial Infarction, Stem Cell Therapy, Coronary Artery Bypass Grafting, Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Contraindications to magnetic resonance imaging.
Need for urgent or emergent revascularization.
Severe valvular heart disease.
Confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
Prior cardiac surgery.
Stroke within 3 months prior to CABG.
Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
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
Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
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
Significant cognitive impairment.
Any condition associated with a life expectancy of less than 6 months.
Participation in other studies.
Positive laboratory test results for HIV, HBC, and HCV.
Pregnant woman.
Inability or unwillingness to provide written informed consent.

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

stem cells injection

palcebo intramyocardial injection

Arm Description

Direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG

Direct intramyocardial injection of placebo containing saline and 5% human serum albumin during CABG.

Outcomes

Primary Outcome Measures

major adverse cardiac events

Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery

Secondary Outcome Measures

left ventricular function

Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram

Full Information

NCT ID

NCT01267331

First Posted

December 23, 2010

Last Updated

January 11, 2011

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01267331

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

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

Old Myocardial Infarction, Chronic Myocardial Ischemia, Left Ventricular Dysfunction

Keywords

Old Myocardial Infarction, Stem Cell Therapy, Coronary Artery Bypass Grafting, Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

stem cells injection

Arm Type

Experimental

Arm Description

Direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG

Arm Title

palcebo intramyocardial injection

Arm Type

Placebo Comparator

Arm Description

Direct intramyocardial injection of placebo containing saline and 5% human serum albumin during CABG.

Intervention Type

Procedure

Intervention Name(s)

bone marrow mononuclear cells injection

Other Intervention Name(s)

autologous bone marrow mononuclear cells

Intervention Description

Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.

Intervention Type

Procedure

Intervention Name(s)

placebo intramyocardial injection

Other Intervention Name(s)

palcebo

Intervention Description

Participants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG.

Primary Outcome Measure Information:

Title

major adverse cardiac events

Description

Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery

Time Frame

6 months

Secondary Outcome Measure Information:

Title

left ventricular function

Description

Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18 and 75 years. Scheduled to undergo CABG. At least 3 months since last episode of myocardial infarction. Echocardiogram-assessed LVEF between 15 and 40% (Simpson's rule). Abnormal wall motion of at least one segment due to prior myocardial infarction shown by echocardiography or left ventriculography. Abnormal myocardial perfusion in infarcted area by SPECT. Willingness to participate and ability to provide written informed consent. Exclusion Criteria: Contraindications to magnetic resonance imaging. Need for urgent or emergent revascularization. Severe valvular heart disease. Confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes. Prior cardiac surgery. Stroke within 3 months prior to CABG. Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.) 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 Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3 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 Significant cognitive impairment. Any condition associated with a life expectancy of less than 6 months. Participation in other studies. Positive laboratory test results for HIV, HBC, and HCV. Pregnant woman. Inability or unwillingness to provide written informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changqing Gao, MD

Phone

+8601066938035

gaochq301@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Zhang, MD

Phone

+8601066938336

drzhanglin@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gao Changqing, MD

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang Rong, MD

First Name & Middle Initial & Last Name & Degree

Zhang Lin, MD

12. IPD Sharing Statement

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

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