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

Early Phase 1Enrolling By InvitationNCT07503028

Celregen Therapeutics10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

T1DM - Type 1 Diabetes Mellitus Pancreatogenic Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-70 years, any gender. 2. Long-standing type 1 diabetes or pancreatic diabetes. 3. Significant pancreatic islet dysfunction. 4. Hemoglobin A1c within clinically acceptable range. 5. At least 1 hypoglycemic event requiring external intervention within 12 months. 6. Able to comply with intensive glucose management. 7. Agree to use the study-designated monitoring device. 8. Psychologically stable. 9. Full legal capacity. Exclusion Criteria: 1. Type 2 diabetes. 2. Body mass index (BMI) \> 30 kg/m². 3. Uncontrolled diabetic retinopathy or severe diabetic foot complications. 4. Active infection or positive serology for relevant pathogens. 5. Severe cardiovascular disease. 6. Uncontrolled hypertension. 7. Hematologic disorders affecting HbA1c accuracy. 8. Abnormal liver function. 9. Prior islet transplantation. 10. Renal impairment or insufficient post-transplant recovery. 11. Significant renal impairment. 12. Recent invasive fungal infection. 13. Severe hematologic abnormalities. 14. Coagulopathy. 15. Inadequate contraceptive compliance. 16. Active malignancy. 17. History of substance abuse. 18. Severe gastrointestinal/malabsorption disorders. 19. Severe psychiatric disorder. 20. Participation in other clinical trials within 6 months. 21. Live-attenuated vaccine received within 2 months prior to enrollment. 22. Inability to undergo standard imaging. 23. Other factors deemed unsuitable by investigator.

Outcomes

Primary Outcomes

Safety as assessed by number of adverse events accoridng to CTCAE v 6.0

Number of adverse events as assessed by CTCAE v6.0，including Adverse Events of Special Interest (AESI), Treatment-Related Adverse Events (TEAE), Treatment-Related Adverse Events (TRAE), and Procedure-Related Adverse Events (PRAE); Serious Adverse Events (SAE), Treatment-Related Serious Adverse Events (TRSAE), and Procedure-Related Serious Adverse Events (PRAE)