Phase I Clinical Study to Evaluate the Safety and Efficac... | NCT06731218

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

NCT06731218

Sponsor

Hangzhou Reprogenix Bioscience, Inc

Status

Recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

10Estimated

Phase

Phase 1

Conditions

Diabetes Mellitus, Type 1
Diabetes Mellitus

Interventions

RGB-5088

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

Dec 9, 2024

First Submission Date that Met QC Criteria

Dec 9, 2024

First Posted Date

Dec 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2025

Last Update Posted Date

Sep 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RGB-5088	Experimental	Transplantation under the anterior rectus sheath	Biological: RGB-5088

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RGB-5088	Biological	Transplantation under the anterior rectus sheath	RGB-5088

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Linlin Jiang	Contact	+86+571-88601920		Linlin.jiang@reprogenix.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin First Center Hospital	Recruiting	Tianjin	Tianjin Municipality	300000	China

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided