Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

ischemic cardiomyopathy
Have signed informed consent form approved by the ethics committee
Left ventricular infarction area seriously low movement to no movement
...
ischemic cardiomyopathy
Have signed informed consent form approved by the ethics committee
Left ventricular infarction area seriously low movement to no movement
The low whole left ventricular systolic function (LVEF 45% or less)
Age from 30 to 80 years
Have line or quasi coronary interventional treatment
Willing to accept patients with follow-up evaluation

Exclusion Criterias

Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
Other serious uncontrolled system disease
Unstable cerebral lesions
...
Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
Other serious uncontrolled system disease
Unstable cerebral lesions
Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L
No function damage in patients with acute myocardial infarction
Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint)
Non elevation between S-wave and T-wave in patients with acute myocardial infarction
Cannot use the test dose atorvastatin
Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
To prepare or have the pregnancy women patients
Cognitive dysfunction and dementia patients, patients with severe mental illness
Patients with severe physical disabilities can't regular follow-up
Acute infectious diseases
Patients unable or unwilling to sign a consent form
malignant tumor
Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal

Summary

Conditions
Ischemic Cardiomyopathy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 80 years
Gender
Both males and females

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 cel...

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 .

Inclusion Criterias

ischemic cardiomyopathy
Have signed informed consent form approved by the ethics committee
Left ventricular infarction area seriously low movement to no movement
...
ischemic cardiomyopathy
Have signed informed consent form approved by the ethics committee
Left ventricular infarction area seriously low movement to no movement
The low whole left ventricular systolic function (LVEF 45% or less)
Age from 30 to 80 years
Have line or quasi coronary interventional treatment
Willing to accept patients with follow-up evaluation

Exclusion Criterias

Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
Other serious uncontrolled system disease
Unstable cerebral lesions
...
Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
Other serious uncontrolled system disease
Unstable cerebral lesions
Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L
No function damage in patients with acute myocardial infarction
Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint)
Non elevation between S-wave and T-wave in patients with acute myocardial infarction
Cannot use the test dose atorvastatin
Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
To prepare or have the pregnancy women patients
Cognitive dysfunction and dementia patients, patients with severe mental illness
Patients with severe physical disabilities can't regular follow-up
Acute infectious diseases
Patients unable or unwilling to sign a consent form
malignant tumor
Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal

Locations

Shijiazhuang, Hebei, 050000
Shijiazhuang, Hebei, 050000

Tracking Information

NCT #
NCT01946048
Collaborators
Not Provided
Investigators
  • Study Chair: Baoyong Yan, Doctor The First Hospital of Hebei Medical University Study Director: Gang Liu, Doctor The First Hospital of Hebei Medical University Principal Investigator: Guoping Ma, Master The First Hospital of Hebei Medical University Principal Investigator: Jun Zhang, Master The First Hospital of Hebei Medical University
  • Study Chair: Baoyong Yan, Doctor The First Hospital of Hebei Medical University Study Director: Gang Liu, Doctor The First Hospital of Hebei Medical University Guoping Ma, Master The First Hospital of Hebei Medical University Principal Investigator: Jun Zhang, Master The First Hospital of Hebei Medical University