Type 1 Diabetes Clinical Trial
Official title:
Functional Survival of Beta Cell Allografts After Transplantation in the Peritoneal Cavity of Non-uremic Type 1 Diabetic Patients
Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT.
Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min
during hyperglycemic clamp at 180 mg/dl.
The investigators hypothesize that functional beta-cell mass will be more than 20% compared
to healthy controls.
Secondary outcome measurements:
Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.
The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against
base-line (base-line = before first intraperitoneal transplantation):
- metabolic control
- safety parameters
- episodes of hypoglycemia
- islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and
alloantigens using pre-transplant measurements as base-line The investigators
hypothesize that metabolic control and prevalence of hypoglycemia, will be
significantly improved till PT month 12.
Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time
of the second implant. Comparison with composition of graft, identification of
microenvironment of host origin and correlation with functional assessment will be
performed.
In recipients with loss of long-term function after intraportal implantation (Group A)
1. To implant an alginate embedded human beta cell graft in a "therapeutic" dose in the
intraperitoneal cavity of type 1 diabetic patients under immunosuppression with
tacrolimus/MMF.
2. To obtain histopathology of a biopsy specimen of the intraperitoneal human beta cell
implant.
3. To assess the safety profile, metabolic and immune effects of alginate embedded
implants in the intraperitoneal cavity.
In patients that are candidates for islet cell transplantation (Group B)
4. To implant an alginate embedded human beta cell graft in a "therapeutic" dose in
intraperitoneal cavity of type 1 diabetic patients under immunosuppression with
tacrolimus/MMF.
5. To obtain histopathology of a biopsy specimen of the intraperitoneal human beta cell
implant
6. To assess the safety profile, metabolic and immune effects of alginate embedded
implants in the intraperitoneal cavity.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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