Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy
NCT ID: NCT01946048
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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mesenchymal stem cells
Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.
mesenchymal stem cells
Procedure: Selected patients were randomly divided into a cell therapy group and a control group.
Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.
Interventions
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mesenchymal stem cells
Procedure: Selected patients were randomly divided into a cell therapy group and a control group.
Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.
Eligibility Criteria
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Inclusion Criteria
2. ischemic cardiomyopathy
3. Left ventricular infarction area seriously low movement to no movement
4. The low whole left ventricular systolic function (LVEF 45% or less)
5. Have line or quasi coronary interventional treatment
6. Willing to accept patients with follow-up evaluation
7. Have signed informed consent form approved by the ethics committee
Exclusion Criteria
2. No function damage in patients with acute myocardial infarction
3. Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
4. Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
5. Acute infectious diseases
6. Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
7. Severe renal disease, creatinine clearance \< 36 ml/min, serum creatinine \> 265 umol/L
8. Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) \> 4 times the upper limit of normal
9. Unstable cerebral lesions
10. malignant tumor
11. Cognitive dysfunction and dementia patients, patients with severe mental illness
12. Patients with severe physical disabilities can't regular follow-up
13. Other serious uncontrolled system disease
14. To prepare or have the pregnancy women patients
15. Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
16. Cannot use the test dose atorvastatin
17. 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)
18. Patients unable or unwilling to sign a consent form
30 Years
80 Years
ALL
No
Sponsors
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Hebei Medical University
OTHER
Responsible Party
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Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Principal Investigators
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Baoyong Yan, Doctor
Role: STUDY_CHAIR
The First Hospital of Hebei Medical University
Gang Liu, Doctor
Role: STUDY_DIRECTOR
The First Hospital of Hebei Medical University
Guoping Ma, Master
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Hebei Medical University
Jun Zhang, Master
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Hebei Medical University
Locations
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the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Other Identifiers
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12276102D-Cardiac Disease
Identifier Type: -
Identifier Source: org_study_id