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

NCT01267331 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-01-12

No results posted yet for this study

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

Interventions

PROCEDURE

bone marrow mononuclear cells injection

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

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Gao Changqing, MD · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01267331 on ClinicalTrials.gov