Islet Allotransplantation for Type 1 Diabetic Patients

NCT03259256 | Unknown Phase 3

• 1 other identifier: Y-03
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetic

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• insulin independence

  One year after the last transplant

• Hypoglycemic episodes by HYPO score

  3 months after transplantation

• degenerative complications of diabetes

  18 months after transplantation

Study Arms (1)

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.

Procedure: Allogeneic transplantation of intrahepatic islet

Interventions

Allogeneic transplantation of intrahepatic islet PROCEDURE

Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy

Allogeneic transplantation of human islet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Study Officials

• ping Xue, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ping Xue, PhD

CONTACT

0086-020-34153080; gyeygdwk@163.com

xiaofeng Jiang, MD

CONTACT

0086-020-34153080; gyeygdwk@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 23, 2017
• Study Start: April 23, 2017
• Primary Completion: August 31, 2018
• Study Completion: June 30, 2019
• Last Updated: September 26, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)