The neonatal pig islets will be used as donor culturing with our modified culture medium. At the same time the autologous T regulatory cells will be used to induce specific immune tolerance for porcine islets grafts combined the costimulation of T cell activation channel blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Porcine islets: 10000IEQ/Kg; Tacrolimus: 0.087mg/kg, Bid; mycophemo-latemofetil (MMF): 1g x 2/d; NULOJIX(belatacept): Day 1 (prior to transplantation), Day 5, Week 2, Week 4, Week 8, Week 12 10mg/kg
Autologous Treg: 2x10\^6/Kg
Cell Transplantation and Gene Therapy Institute
Changsha, Hunan, China
Blood glucose
Before and after transplantation the patient will be tested the blood glucose. If the blood glucose within 24 hours is stable and no occurrence of diabetic ketoacidosis and hypoglycemia.Thirty percent reduction of exogenous insulin requirement will be considered as effective.
Time frame: 1 year
Porcine C-peptide
The patient will be detected the porcine C-peptide levels after transplantion every three months.
Time frame: 1 years
Hemoglobin A1c
After transplantation the patient will be checked hemoglobin A1c every month.The level of HbA1c less than 6.5% was considered as effective.
Time frame: 1 years
AST
AST will be tested every three months.
Time frame: 1 years
ALT
ALT will be tested every three months.
Time frame: 1 years
Scr
Scr will be tested every three months.
Time frame: 1 years
BUN
BUN will be tested every three months.
Time frame: 1 years
Ultrasonic examination for liver
Ultrasonic examination will be used for the recipient's liver before transplantation and every three month post transplantation.
Time frame: 1 years
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MRI for liver
MRI will be used for liver before transplantaion and every three month post transplantation.
Time frame: 1 years
Virus detection
The recipient's serum and peripheral blood monouclear cells (PBMC) will be collected for virus detection every six months.
Time frame: 2 years
Immune cells detection
The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected for immune cell's analysis.
Time frame: 1 years
Cytokine detection
The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected cytokine beads array (CBA) test.
Time frame: 1 years