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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
Sponsor: Celregen Therapeutics
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-10-17
Completion Date
2028-01-18
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
CRG002
Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat
Locations (1)
The First Affiliated Hospital of Anhui Medicaluniversity
Hefei, Anhui, China