Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Week 52 Post-Transplantation Compared to Baseline
The percentage of participants whose daily insulin requirement is reduced by at least 50% at 52 weeks after organoid transplantation, compared to their baseline insulin dose.
Time frame: From enrollment to the end of treatment at 52 weeks post-transplantation
Proportion of Participants with HbA1c < 7.0% at Week 52 Post-Transplantation
The percentage of participants achieving HbA1c levels \<7.0% at 52 weeks post-transplantation, indicating improved long-term glycemic control.
Time frame: From enrollment to the end of treatment at 52 weeks post-transplantation
Number of Participants with No Episodes of Severe Hypoglycemia Between Weeks 12 and 52 Post-Transplantation
The number of participants who report zero episodes of severe hypoglycemia during the 12 to 52 weeks post-transplantation period.
Time frame: From Week 12 to Week 52 post-transplantation
Proportion of Participants with HbA1c < 7.0% at Weeks 12, 26, and 52 Post-Transplantation
Percentage of participants achieving HbA1c \< 7.0% at each follow-up time point to assess glycemic control over time.
Time frame: Weeks 12, 26, and 52 post-transplantation
Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Weeks 12, 26, and 52 Post-Transplantation
Percentage of participants whose insulin requirement is reduced by at least 50% at three time points post-transplantation.
Time frame: Weeks 12, 26, and 52 post-transplantation
Proportion of Participants Achieving Insulin Independence at Weeks 26 and 52 Post-Transplantation
Percentage of participants who achieve complete insulin independence by Week 26 and Week 52.
Time frame: Weeks 26 and 52 post-transplantation
Proportion of Participants with Stimulated C-Peptide Peak > 0.3 ng/mL Following a Mixed Meal Tolerance Test at Weeks 12, 26, and 52
Percentage of participants with stimulated C-peptide \> 0.3 ng/mL at Weeks 12, 26, and 52, indicating β-cell functional recovery.
Time frame: Weeks 12, 26, and 52 post-transplantation
Time-in-Range (TIR) at Weeks 12, 26, and 52 Post-Transplantation
Proportion of time during which blood glucose levels remain within target glycemic range, as measured by CGM.
Time frame: Weeks 12, 26, and 52 post-transplantation
Mean Amplitude of Glycemic Excursions (MAGE) at Weeks 12, 26, and 52 Post-Transplantation
Glycemic variability measured by the average amplitude of glucose excursions as recorded by CGM.
Time frame: Weeks 12, 26, and 52 post-transplantation
Cumulative Number of Hypoglycemic Episodes at Weeks 12, 26, and 52 Post-Transplantation
Number of documented hypoglycemic events recorded during follow-up.
Time frame: Weeks 12, 26, and 52 post-transplantation
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Safety profile assessed by the number and type of adverse events recorded over the treatment period.
Time frame: From enrollment to Week 52 post-transplantation.
Change in Quality of Life Scores from Baseline to Week 52 Post-Transplantation
Difference in patient-reported quality of life scores from baseline to Week 52.
Time frame: From enrollment to the end of treatment at 52 weeks post-transplantation
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