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The purpose of this study is to determine if islet cell transplantation , is an effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic transplantation of human islet | Experimental | Each subject may receive 1-3 transplantations of allogeneic human islets we will inject the least dose of 3,000 IEQ/kg body weight of the recipient. Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic transplantation of intrahepatic islet | Procedure | Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Obtaining an improvement in glycemic control | The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events | nine months after first and last islet transplants |
| normal glycemic control without insulin | A fasting glucose (> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months | 3 months after graf |
| Measure | Description | Time Frame |
|---|---|---|
| insulin independence | insulin independence | One year after the last transplant |
| Hypoglycemic episodes by HYPO score | Hypoglycemic episodes by HYPO score |
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Inclusion Criteria:
Clinical diagnosis of type 1 diabetes 18 <Age <70 years Evolution of diabetes for more than 5 years Regular patient follow-up (> or equal to 2 visits per year from the same diabetologist) ABO compatibility with the donor Cross match negative Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity <20% Accepting patients effective contraception during the study period
Exclusion Criteria:
Clinical diagnosis of type 2 diabetes BMI > 28 Need insulin < 28 U per day Pregnancy, lactation Psychiatric Disorders Inability to communicate or cooperate with the investigator Lack of therapeutic compliance, including HbA1C > 12% Chronic liver disease Proliferative retinopathy unstabilized History of cancer, whatever the date, except for basal or squamous cell skin cancers over 1 year.
Systemic infection Chronic high risk of requiring corticosteroids Need for long-term corticosteroid, outside that specified in renal transplantation, the patients will be weaned before transplantation Anticoagulant vitamin K or antiplatelet treatments Platelets < 100 giga/L and/or neutrophils <1.5 giga/L Chronic intoxication by alcohol, tobacco, or other substance (abstinence > 6 months required) Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2 Ascites
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ping Xue, PhD | Contact | 0086-020-34153080 | gyeygdwk@163.com | |
| xiaofeng Jiang, MD | Contact | 0086-020-34153080 | gyeygdwk@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ping Xue, PhD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
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| 3 months after transplantation |
| degenerative complications of diabetes | degenerative complications of diabetes | 18 months after transplantation |