Diabetes Mellitus
Conditions
Brief summary
This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with diabetes mellitus.
Interventions
BIOLOGICALiPSC-derived islet cell
iPSC-derived islet cell infusion
Sponsors
Peking University First Hospital
Hangzhou Reprogenix Bioscience, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects aged 18 years or older, of any sex. * Duration of diabetes \> 5 years. * Body mass index (BMI) 18-35 kg/m². * Receiving insulin therapy. Key
Exclusion criteria
* Presence of HIV infection , or active acute or chronic hepatitis infection (HBV or HCV), or Treponema pallidum infection. * Active pulmonary tuberculosis or patients undergoing treatment for suspected tuberculosis. * Uncontrolled systemic fungal, bacterial, viral, or other infections . * Presence of severe diabetic complications. * Presence of severe organic lesions in vital organs such as the heart, lungs, or brain. * History of malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | From enrollment to month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in glycosylated hemoglobin (HbA1c) | From enrollment to month 6 |
| Change from baseline in exogenous insulin dosage | From enrollment to month 6 |
Countries
China
Outcome results
None listed