This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.
Age 18-65 years (inclusive), male or female.
Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years.
Body mass index (BMI) 18-30 kg/m².
Glycated hemoglobin (HbA1c) 7.0%-10.0%.
Diagnosis of any form of diabetes other than T2DM.
Daily insulin dose >1.5 U/kg or total daily dose <20 U.
Fasting plasma glucose ≥15.0 mmol/L.
Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).
Single group
RGB-5088
Biological/VaccineTransplantation under the anterior rectus sheath
Safety as assessed by number of subjects with adverse events
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Safety as assessed by number of subjects with adverse events
Proportion of subjects who are insulin independent
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
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This trial is not recruiting at the moment. You can still explore other options:
