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

Enrolling by invitation · Early Phase 1

Conditions studied: T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus

In brief

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 facts

Study ID

NCT07503028

Run by

Celregen Therapeutics

People needed

10

Starts

2025-10-17

Expected to finish

2028-01-18

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Full legal capacity.

You may not qualify if…

• 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.
• Severe cardiovascular disease.
• Uncontrolled hypertension.
• Hematologic disorders affecting HbA1c accuracy.
• Abnormal liver function.
• Prior islet transplantation.
• Renal impairment or insufficient post-transplant recovery.
• Significant renal impairment.
• Recent invasive fungal infection.
• Severe hematologic abnormalities.
• Coagulopathy.
• Inadequate contraceptive compliance.
• Active malignancy.
• History of substance abuse.
• Severe gastrointestinal/malabsorption disorders.
• Severe psychiatric disorder.
• Participation in other clinical trials within 6 months.
• Live-attenuated vaccine received within 2 months prior to enrollment.
• Inability to undergo standard imaging.
• Other factors deemed unsuitable by investigator.

Where it is running

• The First Affiliated Hospital of Anhui Medicaluniversity — Hefei, Anhui, China

Full record on ClinicalTrials.gov

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