Safety and Efficacy Study of Islets Xenotransplantation

Type 1 Diabetes Clinical Trial

Official title:

Investigation of Safety and Efficacy Study of Islets Xenotransplantation for Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162237
• Other study ID #: CellTransplant&GeneTherapy2013
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2018

Study information

• Verified date: May 2020
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male and female patients age 18 to 40 years of age;

• Type 1 diabetes mellitus for at least 5 years;

• Body weight 40 to 60kg;

• Ability to provide written informed consent;

• Manifest signs and symptoms that are severe enough to be incapacitating;

• Patients with poor diabetes control (HbA1c > 9% );

• Patients have diabetes ketoacidosis or hypoglycemia more than once

Exclusion Criteria:

• Age < 18 years or > 60 years;

• Diabetes history < 5 years;

• Body weight > 80 kg;

• Exogenous insulin requirement > 1 unit/kg/day;

• Blood test: hemoglobin male < 90g/l, female < 90 g/l) or Wbc <3×109/L, lymphocyte <1.5×10^9/L; or platelet < 80×10^9/L; activated- partial-thromboplastin-time (APTT) > normal value (31-43s)10s;

• Liver dysfunction;

• Kidney dysfunction;

• Cardiopulmonary dysfunction;

• Combined mental illness, cancer, infection, severe trauma, pancreatitis, surgery or other stress situations for patients; gastric ulcer patients, any bleeding disorders, tuberculosis infection and active infection including hepatitis B, hepatitis C, HIV, or John Cunningham virus;

• Serological detection Epstein-Barr virus (EBV) or Cytomegalovirus (CMV)negative;

• Patient have taken immunosuppressant in recent one year With high incidence of malignancy in three generation;

• Women not using effective contraception of childbearing age, or planning pregnancy in nearly two years or being pregnant or lactating;

• Patients can not comply with the research program to complete the diagnosis and treatment;

• Patients not be passed by Ethics committee

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Porcine islets
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
Autologous Treg: 2x10^6/Kg

Locations

Country	Name	City	State
China	Cell Transplantation and Gene Therapy Institute	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Wei Wang,MD	Hunan Xeno-life Science Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Porcine C-peptide	The patient will be detected the porcine C-peptide levels after transplantion every three months.	1 years
Secondary	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.	1 years
Secondary	AST	AST will be tested every three months.	1 years
Secondary	ALT	ALT will be tested every three months.	1 years
Secondary	Scr	Scr will be tested every three months.	1 years
Secondary	BUN	BUN will be tested every three months.	1 years
Secondary	Ultrasonic examination for liver	Ultrasonic examination will be used for the recipient's liver before transplantation and every three month post transplantation.	1 years
Secondary	MRI for liver	MRI will be used for liver before transplantaion and every three month post transplantation.	1 years
Secondary	Virus detection	The recipient's serum and peripheral blood monouclear cells (PBMC) will be collected for virus detection every six months.	2 years
Secondary	Immune cells detection	The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected for immune cell's analysis.	1 years
Secondary	Cytokine detection	The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected cytokine beads array (CBA) test.	1 years