Clinical trial NCT01946048: Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy
Official title: Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ischemic Cardiomyopathy
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility criteria: Inclusion Criteria:

1. Age from 30 to 80 years
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:

1. Non elevation between S-wave and T-wave in patients with acute myocardial infarction
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

Primary outcomes:
measure: The examination of heart function
timeFrame: Post cell transplantation: 1, 3, 6 months
Secondary outcomes:
measure: all-cause mortality
timeFrame: Post cell transplantation: one year
measure: all-cause morbidity
timeFrame: Post cell transplantation: one year
measure: major adverse cardiac and cerebrovascular events
timeFrame: Post cell transplantation: one year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Baoyong Yan, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Gang Liu, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Guoping Ma, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Jun Zhang, Master
role: PRINCIPAL_INVESTIGATOR
References: