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

Left Ventricular Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01267331
• Other study ID #: 2006AA02A104
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 23, 2010
• Last updated: January 11, 2011
• Start date: December 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2010
• Source: Chinese PLA General Hospital
• Contact: Changqing Gao, MD
• Phone: +8601066938035
• Email: gaochq301[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• bone marrow mononuclear cells injection
Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.
• placebo intramyocardial injection
Participants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	left ventricular function	Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram	6 months	No