Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-01 @ 12:42 PM
Study NCT ID:
NCT03259256
Status:
UNKNOWN
Last Update Posted:
2017-09-26
First Post:
2017-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Islet Allotransplantation for Type 1 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-24', 'studyFirstSubmitDate': '2017-08-19', 'studyFirstSubmitQcDate': '2017-08-19', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obtaining an improvement in glycemic control', 'timeFrame': 'nine months after first and last islet transplants', 'description': 'The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events'}, {'measure': 'normal glycemic control without insulin', 'timeFrame': '3 months after graf', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'insulin independence', 'timeFrame': 'One year after the last transplant', 'description': 'insulin independence'}, {'measure': 'Hypoglycemic episodes by HYPO score', 'timeFrame': '3 months after transplantation', 'description': 'Hypoglycemic episodes by HYPO score'}, {'measure': 'degenerative complications of diabetes', 'timeFrame': '18 months after transplantation', 'description': 'degenerative complications of diabetes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical 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\n\nExclusion Criteria:\n\nClinical 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.\n\nSystemic 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\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03259256', 'briefTitle': 'Islet Allotransplantation for Type 1 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Islet Allotransplantation for Type 1 Diabetic Patients', 'orgStudyIdInfo': {'id': 'Y-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allogeneic transplantation of human islet', 'description': '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.', 'interventionNames': ['Procedure: Allogeneic transplantation of intrahepatic islet']}], 'interventions': [{'name': 'Allogeneic transplantation of intrahepatic islet', 'type': 'PROCEDURE', 'description': 'Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy', 'armGroupLabels': ['Allogeneic transplantation of human islet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ping Xue, PhD', 'role': 'CONTACT', 'email': 'gyeygdwk@qq.com', 'phone': '+86-020-34153080'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'ping Xue, PhD', 'role': 'CONTACT', 'email': 'gyeygdwk@163.com', 'phone': '0086-020-34153080'}, {'name': 'xiaofeng Jiang, MD', 'role': 'CONTACT', 'email': 'gyeygdwk@163.com', 'phone': '0086-020-34153080'}], 'overallOfficials': [{'name': 'ping Xue, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}