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This study will evaluate the efficacy and safety of allogeneic pancreatic islet cells transplantation in patients with "brittle" type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YD02-2022 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YD02-2022 | Biological | Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual β-Cell function (RBCF) | Evaluation of the magnitude of C-peptide change after transplantation | 12 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control (HbA1c) | Evaluation of the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events | 52 weeks post-transplant |
| Treatment (insulin-independent) | Evaluation of the proportion of subjects who are insulin-independent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiqiong Gu, PhD | Contact | 86-21-64370045 | 671701 | Gwq10978@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University | Recruiting | Shanghai | 200025 | 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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| 12 weeks and 52 weeks post-transplant |
| Treatment (insulin requirement) | Evaluation of the percentage reduction in insulin requirement | 12 weeks and 52 weeks post-transplant |
| Glycemic control (MAGE) | Evaluation of the average amplitude of glycemic fluctuations (MAGE) in subjects | 12 weeks and 52 weeks post-transplant |
| Hypoglycemia (HYPO) | Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO) | baseline and 52 weeks post-transplant |
| Quality of life score | Evaluation of the quality of life score in subjects | baseline and 52 weeks post-transplant |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |