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

NCT01267331 | Unknown Phase 1 DMC

• 1 other identifier: 2006AA02A104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Myocardial Infarction; Chronic Myocardial Ischemia; Left Ventricular Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac events

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

  6 months

Secondary Outcomes (1)

• left ventricular function

  6 months

Study Arms (2)

stem cells injection

EXPERIMENTAL

Direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG

Procedure: bone marrow mononuclear cells injection

palcebo intramyocardial injection

PLACEBO COMPARATOR

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

Procedure: placebo intramyocardial injection

Interventions

bone marrow mononuclear cells injection PROCEDURE

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

Also known as: autologous bone marrow mononuclear cells

stem cells injection

placebo intramyocardial injection PROCEDURE

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

Also known as: palcebo

palcebo intramyocardial injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gao Changqing, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Changqing Gao, MD

CONTACT

+8601066938035; gaochq301@yahoo.com

Lin Zhang, MD

CONTACT

+8601066938336; drzhanglin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 28, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: January 12, 2011

Record last verified: 2010-12

Locations

CN (1)