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Islet Allotransplantation for Type 1 Diabetic Patients

NCT ID: NCT03259256

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Type 1 Diabetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Allogeneic transplantation of intrahepatic islet

Intervention Type PROCEDURE

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

Interventions

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Allogeneic transplantation of intrahepatic islet

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

Intervention Type PROCEDURE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ping Xue, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

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The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ping Xue, PhD

Role: CONTACT

[email protected]
0086-020-34153080

xiaofeng Jiang, MD

Role: CONTACT

[email protected]
0086-020-34153080

Facility Contacts

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ping Xue, PhD

Role: primary

[email protected]
+86-020-34153080

Other Identifiers

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Y-03

Identifier Type: -

Identifier Source: org_study_id