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:
Hangzhou Reprogenix Bioscience, Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: