Safety and Efficacy Study of Islets Xenotransplantation

Wei Wang,MD

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Porcine islets; Other: Autologous Treg

Study type: Interventional

Funder types: Other

Identifiers

NCT03162237

CellTransplant&GeneTherapy2013

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Porcine islets and autologous treg

Experimental group

Description:

Porcine islets:10000 islet equivalent（IEQ）/Kg; Treg:2x10\^6/Kg

Treatment:

Other: Porcine islets

Other: Autologous Treg

AutologousTreg

Active Comparator group

Description:

Autologous Treg:2x10\^6/Kg

Treatment:

Other: Autologous Treg