Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
NCT ID: NCT06731218
Last Updated: 2025-09-15
Study Results
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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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2025-02-17
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RGB-5088
Transplantation under the anterior rectus sheath
RGB-5088
Transplantation under the anterior rectus sheath
Interventions
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RGB-5088
Transplantation under the anterior rectus sheath
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
* Stimulated C-peptide \< 0.3 ng/mL;
* The patient had at least one severe hypoglycemia within 12 months before being included in the project
Exclusion Criteria
* Untreated proliferative diabetes retinopathy;
* Serious heart disease;
* Serious gastrointestinal dysfunction ；
* Serious psychological diseases；
* Any history of malignancy;
* Have a history of tobacco, alcohol and drug abuse;
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Hangzhou Reprogenix Bioscience, Inc
INDUSTRY
Responsible Party
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Locations
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Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RGB-5088-01
Identifier Type: -
Identifier Source: org_study_id
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