The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.
Single-center, open label, non-randomized safety and efficacy trial to evaluate co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression. A total of 8 patients will be enrolled in the study and followed for a minimum of 1 year up to 2 years after the last islet transplant, depending on enrollment date.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression
University of California
San Francisco, California, United States
Incidence of adverse events
Safety: Since this study is a pilot non-randomized safety and efficacy trial with patient enrollment limited by budgetary constraints, no direct statistical significance tests can be performed.
Time frame: Minimum of 1 year up to 2 years depending on transplant date
Incidence of post-transplant infections and malignancies
Safety: Since this study is a pilot non-randomized safety and efficacy trial with patient enrollment limited by budgetary constraints, no direct statistical significance tests can be performed.
Time frame: Minimum of 1 year up to 2 years depending on transplant date
Incidence of de novo sensitization
Safety: Since this study is a pilot non-randomized safety and efficacy trial with patient enrollment limited by budgetary constraints, no direct statistical significance tests can be performed.
Time frame: Minimum of 1 year up to 2 years depending on transplant date
Incidence of Insulin independence
Efficacy: Incidence of participants no longer using insulin
Time frame: Minimum of 1 year up to 2 years depending on transplant date
Glycemic control
Assessed by measuring HbA1c using high-performance liquid chromatography
Time frame: Day 75, Day 180, Day 270, Year 1, Year 1.5, Year 2
Hypoglylcemic episodes: Clarke Survey Score
The Clarke survey will be used to assess the frequency and severity of hypoglycemic episodes
Time frame: Day 75, Day 180, Day 270, Year 1
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Hypoglylcemic episodes: Hypo Score
The HYPO score will be used to assess the frequency and severity of hypoglycemic episodes
Time frame: Day 75, Day 180, Day 270, Year 1
Beta cell function as assessed by Mixed Meal Tolerance Test (MMTT)
Results from both MMTT and FSIGT will be used to assess beta cell function
Time frame: Day 75, Day 180, Day 270, Year 1, Year 1.5, Year 2
Beta cell function as assessed by Insulin-Modified Frequently-Sampled Intravenous Glucose ToleranceTest (FSIGT)
Results from both MMTT and FSIGT will be used to assess beta cell function
Time frame: Day 75, Day 180, Day 270, Year 1, Year 1.5, Year 2