Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06731218

Enrollment

Registered

2024-12-12

Start date

2025-02-17

Completion date

2031-12-31

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetes Mellitus, Type 1

Brief summary

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.

Interventions

BIOLOGICALRGB-5088

Transplantation under the anterior rectus sheath

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Age: 18-60 years old (including 18 and 60 years old), male and female; * 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 Key

Exclusion criteria

* Type 2 diabetes patients; * 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.

Design outcomes

Primary

Measure	Time frame
Safety as assessed by number of subjects with adverse events	From RGB-5088 transplantation to one year later
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events	From 90 days to 365 days after RGB-5088 transplantation

Secondary

Measure	Time frame
Safety as assessed by number of subjects with adverse events	From RGB-5088 transplantation to end of study (up to 5 years)
Proportion of subjects who are insulin independent	From 90 days to end of study (up to 5 years)
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events	From 90 days to end of study (up to 5 years)

Countries

China

Contacts

Primary ContactLinlin Jiang

Linlin.jiang@reprogenix.com+86+571-88601920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026