A Phase 3 interventional study of Allogeneic transplantation of intrahepatic islet in Type 1 Diabetic, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Phase 3, Interventional, and Treatment
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.
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
-
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.
Procedure: Allogeneic transplantation of intrahepatic islet
Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy
Obtaining an improvement in glycemic control
The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
Time frame: 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
Time frame: 3 months after graf
insulin independence
insulin independence
Time frame: One year after the last transplant
Hypoglycemic episodes by HYPO score
Hypoglycemic episodes by HYPO score
Time frame: 3 months after transplantation
degenerative complications of diabetes
degenerative complications of diabetes
Time frame: 18 months after transplantation
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital of Guangzhou Medical University