NCT07503028

An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Celregen Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in patients with type 1 diabetes mellitus (T1DM) or pancreatogenic diabetes who have hypoglycemia unawareness or severe hypoglycemic events.

Conditions

• T1DM - Type 1 Diabetes Mellitus
• Pancreatogenic Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	CRG002	Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

Timeline

• Start date: 2025-10-17
• Primary completion: 2028-01-18
• Completion: 2028-01-18
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China