The aim is to Investigate the safety and efficacy of Portal vein infusion Allogeneic Human umbilical cord mesenchymal stem cells combined with Allogeneic islet transplantation for the treatment of diabetes
This is an investigator-initiated trial (IIT). The first part is an open-label, dose-escalation study involving 9 patients between the ages of 18 and 70. The second part is a non-randomized, active comparator-controlled IIT with a parallel design, comparing allogeneic islet transplantation combined with human umbilical cord mesenchymal stem cells (hUCMSCs) to allogeneic islet transplantation alone in patients with diabetes.Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Portal vein infusion human umbilical cord mesenchymal stem cells
Portal vein infusion of allogeneic islet
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSafety assessment: Registration of adverse events
Changes in safety parameters of patients during the study period since baseline. Measured through the registration of adverse events.
Time frame: Throughout the study until Week 52
Efficacy Assessment: Evaluation of islet function
Change of C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at Week 52 compared to test performed before start of treatment.
Time frame: Throughout the study until Week 52
Efficacy Assessment: HbA1c
Changes in patient HbA1c levels from baseline during the study period
Time frame: Week 52
Dose of exogenous insulin
Changes in daily exogenous insulin requirements during the study period
Time frame: Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.