Islet Allotransplantation for Type 1 Diabetic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetic
• Intervention / Treatment: Procedure: Allogeneic transplantation of intrahepatic islet

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Recruiting
      • The second Affiliated Hospital of Guangzhou Medical University
      • Contact: ping Xue, PhD; Phone Number: +86-020-34153080; Email: gyeygdwk@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allogeneic transplantation of human islet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin independence	insulin independence	One year after the last transplant
Hypoglycemic episodes by HYPO score	Hypoglycemic episodes by HYPO score	3 months after transplantation
degenerative complications of diabetes	degenerative complications of diabetes	18 months after transplantation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: ping Xue, PhD, Second Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: August 19, 2017
• First Submitted That Met QC Criteria: August 19, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 24, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Y-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No