Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

Hebei Medical University

Status and phase: Unknown; Phase 1

Conditions: Ischemic Cardiomyopathy

Treatments: Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01946048

12276102D-Cardiac Disease

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 10 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

mesenchymal stem cells

Experimental group

Description:

Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.

Treatment:

Biological: mesenchymal stem cells