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This study is a 24-week single-center, randomized, double-blind, placebo-controlled trial. The trial includes a 3-week early screening and lifestyle education period, 6-week treatment period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional hypoglycemic treatment were randomly assigned to umbilical cord mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion therapy.
This study is a 24-week single-center, randomized, double-blind, placebo-controlled trial. The trial includes a 3-week early screening and lifestyle education period, 6-week treatment period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional hypoglycemic treatment(including insulin) were randomly assigned to umbilical cord mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | The volunteers of the experimental group will be given peripheral intravenously a dose of 0.75*10^6/ kg human umbilical cord mesenchymal stem cells at 0,1,5,6 week. |
|
| control group | Placebo Comparator | The control group will be given the same dose of saline containing human albumin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells | Biological | human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| The changes in HbA1C level | The changes in HbA1C level after transplantation | 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of insulin requirement | Reduction of insulin requirement after transplantation | 24 weeks after treatment |
| The changes in blood glucose level | The changes in blood glucose level after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wang congrong, doctor | Contact | +86-021-38804518 | wcr601@163.com | |
| liu zhongmin, doctor | Contact | +86-021-38804518 | liu.zhongmin@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| wang congrong, doctor | Shanghai East Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Shanghai Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline | Biological | saline containing human albumin will be infused to the control group |
|
| 24 weeks after treatment |
| D004700 | Endocrine System Diseases |
| D017670 |
| Sodium Compounds |