Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery - Full Text View

Purpose

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

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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Heart Attack Heart Diseases

U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:

major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram

Estimated Enrollment:	60
Study Start Date:	December 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267331

Contacts

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

Locations

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

Study Chair:

Gao Changqing, MD

Chinese PLA General Hospital

More Information

No publications provided

Responsible Party:	Gao Changqing, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:	NCT01267331 History of Changes
Other Study ID Numbers:	2006AA02A104
Study First Received:	December 23, 2010
Last Updated:	January 11, 2011
Health Authority:	China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:

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

Additional relevant MeSH terms:

Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Infarction
Ischemia
Myocardial Infarction
Ventricular Dysfunction, Left
Ventricular Dysfunction

Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 21, 2013