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The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.
Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | intramuscular injection of umbilical cord mesenchymal stem cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cells | Biological | Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. |
|
| Measure | Description | Time Frame |
|---|---|---|
| echocardiography | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24h HOLTER | 2 months | |
| The level of serum BNP,TNI,HGF、LIF and G/M-CSF | 3 months | |
| The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxia Hu, MD | Contact | 86-0532-82911676 | qdyxyhjx@126.com | |
| Hong Gao, MS | Contact | 86-0532-82911676 | honggaogloria@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| zipu li, MD Phd | The Affiliated Hospital of Qingdao University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cell Research Center of Medical School Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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|
| 2 months |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |