Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ischemic Cardiomyopathy
- Sponsor
- Hebei Medical University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The examination of heart function
- Last Updated
- 12 years ago
Overview
Brief Summary
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Detailed Description
Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Investigators
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University
Eligibility Criteria
Inclusion Criteria
- •Age from 30 to 80 years
- •ischemic cardiomyopathy
- •Left ventricular infarction area seriously low movement to no movement
- •The low whole left ventricular systolic function (LVEF 45% or less)
- •Have line or quasi coronary interventional treatment
- •Willing to accept patients with follow-up evaluation
- •Have signed informed consent form approved by the ethics committee
Exclusion Criteria
- •Non elevation between S-wave and T-wave in patients with acute myocardial infarction
- •No function damage in patients with acute myocardial infarction
- •Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
- •Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
- •Acute infectious diseases
- •Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
- •Severe renal disease, creatinine clearance \< 36 ml/min, serum creatinine \> 265 umol/L
- •Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) \> 4 times the upper limit of normal
- •Unstable cerebral lesions
- •malignant tumor
Outcomes
Primary Outcomes
The examination of heart function
Time Frame: Post cell transplantation: 1, 3, 6 months
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
Secondary Outcomes
- major adverse cardiac and cerebrovascular events(Post cell transplantation: one year)
- all-cause mortality(Post cell transplantation: one year)
- all-cause morbidity(Post cell transplantation: one year)