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 study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral medication treatment | No Intervention | type 2 diabetics with only oral medications | |
| Oral medication plus BMMCT | Experimental | Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. |
|
| Oral medication plus insulin treatment | No Intervention | Type 2 diabetics who need insulin therapy with oral medications | |
| Oral medication plus insulin plus BMMCT | Experimental | Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMMCT | Other | Bone marrow mononuclear cell transplantation via selective catheterization |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of medication | 1 year | |
| HbA1c | 1 year | |
| adverse event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yizhong Wang, M.D., Ph.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Study Chair |
| Yuanjie Mao, M.D., Ph.D. | Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital | Study Director |
| Lei Lei, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Danping Meng, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Xiyang Zhang, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Xiaolin Jia, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Study Director |
| Qiuming Jiang, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Yufang Li, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Beijing | Beijing Municipality | 100049 | China |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| 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
Not provided
|
| 1 year |
| Principal Investigator |
| Song Dong, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Liyan Yang, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Hong Wang, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Mingchao Ding, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Liqin Cui, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Bin Wang, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Xin Lin, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |
| Han Shi, M.D. | Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital | Principal Investigator |