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| Name | Class |
|---|---|
| Newislet Biotechnology (Shanghai) Ltd. | UNKNOWN |
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The purpose of this clinical trial is to verify the safety and effectiveness of autologous islet organoids transplantation after in vitro expansion for the treatment of pancreatogenic diabetes.
The purpose of this clinical trial is to verify the safety and effectiveness of autologous islet transplantation after in vitro expansion in the forms of functional islet organoids, for the treatment of pancreatogenic diabetes in participants who have undergone pancreatic resection through a single-center single-arm study. The investigators aim to establish the entire operational process of isolating expanding and transplanting islets from the pancreas removed from the participants and managing postoperative care. The investigators hope to accumulate clinical experience in treating pancreatogenic diabetes with transplanted autologous islet cell clusters expanded in vitro establish standard and regulated medical operations and gather materials for future applications of this treatment method in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplantation group | Experimental | transplantation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Islet organoids transplantation | Other | autologous transplantation of ex vivo expanded islet organoids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide secretion | C-peptide detection assay | before transplantation and 1 year after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c level | HbA1c detection assay | before transplantation and 1 year after transplantation |
| Mean Amplitude of Glycemic Excursion (MAGE) | Glucose measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Ma, MD | Contact | 86-18768117002 | xima@zju.edu.cn | |
| Qing Cissy Yu, PhD | Contact | 86-13916205952 | qing.yu@newislet.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng Yan, PhD, MD | Zhejiang University Second Affiliated Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang University Second Affiliated Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| 12 weeks and 52 weeks post transplantation |
| Ryan Hypoglycemia event | recorded events of unaware severe hypoglycemia (glucose level below 3 mmol/L) | baseline and 52 weeks post transplantation |
| Reduced Insulin usage | Reduced insulin usage of over 50% compared with prior to treatment | 12 weeks and 52 weeks post transplantation |