Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2 diabetes.
1. Intervention Details: Biological: umbilical cord/placenta-derived mesenchymal stem cells; Drug: 1. Oral Hypoglycemic Drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. 2. Insulins.
2. Detailed Description:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC and the oral hypoglycemic drugs | Experimental | 1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former oral hypoglycemic drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. and regulates the dosage for 1 year. |
|
| MSC and insulins | Experimental | 1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former insulins and regulates the dosage for 1 year. |
|
| MSC and the combination of drugs and insulins | Experimental | 1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former combination of the oral hypoglycemic drugs and insulins and regulates the dosage for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC | Biological | 1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus | To assess efficacy of MSC through comparing the change of ITT, Hemoglobin A1c, FBG, PBG, C-peptide levels and T cell subsets with that of baseline.
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the incidence and severity of adverse events of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus | To evaluate if there have occured the adverse everts such as fever, allergy, et al. and their severity. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chengyun zheng, Ph. D | Contact | +86-531-85875635 | chengyun.zheng@ki.se, kdx2002@126.com |
| Name | Affiliation | Role |
|---|---|---|
| chengyun zheng, Ph. D | Department of Hematology of The 2nd Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology of the 2nd Hospital of Shandong University | Recruiting | Jinan | Shandong | 250033 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25651730 | Derived | Kong D, Zhuang X, Wang D, Qu H, Jiang Y, Li X, Wu W, Xiao J, Liu X, Liu J, Li A, Wang J, Dou A, Wang Y, Sun J, Lv H, Zhang G, Zhang X, Chen S, Ni Y, Zheng C. Umbilical cord mesenchymal stem cell transfusion ameliorated hyperglycemia in patients with type 2 diabetes mellitus. Clin Lab. 2014;60(12):1969-76. doi: 10.7754/clin.lab.2014.140305. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006946 | Hyperinsulinism |