Islet Allotransplantation for Type 1 Diabetic Patients

Phase 3

• Conditions: Type 1 Diabetic

• Registration Number: NCT03259256
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

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 followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-23
• Study First Submitted: 2017-08-19
• Study First Submitted QC: 2017-08-19
• Study First Posted: 2017-08-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-24
• Last Update Posted: 2017-09-26
• Primary Completion: 2018-08-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Obtaining an improvement in glycemic control	nine months after first and last islet transplants	The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
normal glycemic control without insulin	3 months after graf	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

Secondary Outcome Measures

Name	Time	Method
insulin independence	One year after the last transplant	insulin independence
Hypoglycemic episodes by HYPO score	3 months after transplantation	Hypoglycemic episodes by HYPO score
degenerative complications of diabetes	18 months after transplantation	degenerative complications of diabetes

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China