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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Wenzhou Medical University | OTHER |
| Zhenjiang First People's Hospital | OTHER |
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The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.
Diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.The traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. However, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. Therefore, such therapy can be offered to a very limited number of patients only. MSC-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. MSCs also have been noted to possess immunomodulatory effects in vivo. Thus, their potential for clinical use as a cell-based therapy should be focused and observation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional therapy control | Active Comparator |
| |
| Stem cell infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenSCs transplantation | Biological | 1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The acute reaction and severity of adverse events related to the stem cell infusion procedure | 2 years | |
| Number of severe and documented hypoglycemic events | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlie Xiang, Professor | Contact | 86-571-87236436 | cxiang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Charile Xiang, Professor | S-Evans Biosicences Co.,Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| exogenous indulin injection daily | Drug | traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose. |
|
| C-peptide release test |
| 3 months |
| The reduction in fasting blood glucose (FBG) | 1 year |
| The increase in basal C-peptide | 1 year |
| The postprandial blood glucose | 1 year |
| The random glucose level | 2 years |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |