Pancreatogenic Diabetes Mellitus, T1DM - Type 1 Diabetes Mellitus
Conditions
Brief 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.
Interventions
DRUGCRG002
Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat
Sponsors
Celregen Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by number of adverse events accoridng to CTCAE v 6.0 | Within one year after CRG-002 transplantation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily insulin dosage of subjects | Within one year after CRG-002 transplantation | — |
| Time to subjects achieving insulin independence. | Within one year after CRG-002 transplantation | — |
| Numbers of subjects achieving insulin independence. | Within one year after CRG-002 transplantation | — |
| Changes in blood glucose levels | Within one year after CRG-002 transplantation | Changes in blood glucose levels in subjects after CRG-002 transplantation |
| Changes in Time in range of glucose | Within one year after CRG-002 transplantation | — |
| Time to achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or a ≥1% reduction from baseline. | Within one year after CRG-002 transplantation | — |
| Number of subjects achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or ≥1% HbA1c reduction from baseline (if baseline HbA1c <7.0%). | Within one year after CRG-002 transplantation | — |
Countries
China
Outcome results
None listed