Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06731218
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2024-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as assessed by number of subjects with adverse events', 'timeFrame': 'From RGB-5088 transplantation to one year later'}, {'measure': 'Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events', 'timeFrame': 'From 90 days to 365 days after RGB-5088 transplantation'}], 'secondaryOutcomes': [{'measure': 'Safety as assessed by number of subjects with adverse events', 'timeFrame': 'From RGB-5088 transplantation to end of study (up to 5 years)'}, {'measure': 'Proportion of subjects who are insulin independent', 'timeFrame': 'From 90 days to end of study (up to 5 years)'}, {'measure': 'Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events', 'timeFrame': 'From 90 days to end of study (up to 5 years)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age: 18-60 years old (including 18 and 60 years old), male and female;\n* Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);\n* Stimulated C-peptide \\< 0.3 ng/mL;\n* The patient had at least one severe hypoglycemia within 12 months before being included in the project\n\nKey Exclusion Criteria:\n\n* Type 2 diabetes patients;\n* Untreated proliferative diabetes retinopathy;\n* Serious heart disease;\n* Serious gastrointestinal dysfunction ；\n* Serious psychological diseases；\n* Any history of malignancy;\n* Have a history of tobacco, alcohol and drug abuse;\n* For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.'}, 'identificationModule': {'nctId': 'NCT06731218', 'briefTitle': 'Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hangzhou Reprogenix Bioscience, Inc'}, 'officialTitle': 'A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'RGB-5088-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RGB-5088', 'description': 'Transplantation under the anterior rectus sheath', 'interventionNames': ['Biological: RGB-5088']}], 'interventions': [{'name': 'RGB-5088', 'type': 'BIOLOGICAL', 'description': 'Transplantation under the anterior rectus sheath', 'armGroupLabels': ['RGB-5088']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongyang Shen', 'role': 'CONTACT', 'email': 'zhongyangshen@sina.com', 'phone': '+86-22-23626606'}, {'name': 'Zhongyang Shen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shusen Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin First Center Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Linlin Jiang', 'role': 'CONTACT', 'email': 'Linlin.jiang@reprogenix.com', 'phone': '+86+571-88601920'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Reprogenix Bioscience, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}