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Islet Allotransplantation for Type 1 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03259256
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetic Procedure: Allogeneic transplantation of intrahepatic islet Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Islet Allotransplantation for Type 1 Diabetic Patients
Actual Study Start Date : April 23, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : June 30, 2019

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




Primary Outcome Measures :
  1. Obtaining an improvement in glycemic control [ Time Frame: nine months after first and last islet transplants ]
    The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events

  2. normal glycemic control without insulin [ Time Frame: 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 :
  1. insulin independence [ Time Frame: One year after the last transplant ]
    insulin independence

  2. Hypoglycemic episodes by HYPO score [ Time Frame: 3 months after transplantation ]
    Hypoglycemic episodes by HYPO score

  3. degenerative complications of diabetes [ Time Frame: 18 months after transplantation ]
    degenerative complications of diabetes



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259256


Contacts
Contact: ping Xue, PhD 0086-020-34153080 gyeygdwk@163.com
Contact: xiaofeng Jiang, MD 0086-020-34153080 gyeygdwk@163.com

Locations
China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: ping Xue, PhD    +86-020-34153080    gyeygdwk@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: ping Xue, PhD Second Affiliated Hospital of Guangzhou Medical University

Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03259256     History of Changes
Other Study ID Numbers: Y-03
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No