Status:
UNKNOWN
Islet Allotransplantation for Type 1 Diabetic Patients
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Type 1 Diabetic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 follow...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
April 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03259256
Start Date
April 23 2017
End Date
June 30 2019
Last Update
September 26 2017
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260