An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002)… (NCT07503028) | Clinical Trial Compass
By InvitationEarly Phase 1
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
China10 participantsStarted 2025-10-17
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years, any gender.
✓. Long-standing type 1 diabetes or pancreatic diabetes.
✓. Significant pancreatic islet dysfunction.
✓. Hemoglobin A1c within clinically acceptable range.
✓. At least 1 hypoglycemic event requiring external intervention within 12 months.
✓. Able to comply with intensive glucose management.
✓. Agree to use the study-designated monitoring device.
✓. Psychologically stable.
Exclusion criteria
✕. Type 2 diabetes.
✕. Body mass index (BMI) \> 30 kg/m².
✕. Uncontrolled diabetic retinopathy or severe diabetic foot complications.
✕. Active infection or positive serology for relevant pathogens.