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This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.
To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| umbilical cord mesenchymal stem cell | Experimental | single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cell | Procedure | allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline exogenous insulin dose at different time points post treatment | 1 month, 3 months,6 months, 12 months, 24 months, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide level | 1 month, 3 months, 6 months, 12 months, 24 months, 36 months | |
| HbA1c level | 1 month, 3 months, 6 months, 12 months, 24 months, 36 months | |
| titres of islet antigen antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalong Zhu, MD.PhD. | Contact | 86-25-83106666 | 61430 | zhudalong@nju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD.PhD. | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35941696 | Derived | Zhang W, Ling Q, Wang B, Wang K, Pang J, Lu J, Bi Y, Zhu D. Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes. Stem Cell Res Ther. 2022 Aug 8;13(1):406. doi: 10.1186/s13287-022-02974-1. |
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| 1 month, 3 months, 6 months, 12 months,24 months, 36 months |
| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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