Safety and Efficacy Study of Islets Xenotransplantation

NCT ID: NCT03162237

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-12-31

Brief 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Porcine islets and autologous treg

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

Group Type: EXPERIMENTAL

Porcine islets

Intervention Type: OTHER

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

Intervention Type: OTHER

Autologous Treg: 2x10\^6/Kg

AutologousTreg

Autologous Treg:2x10\^6/Kg

Group Type: ACTIVE_COMPARATOR

Autologous Treg

Intervention Type: OTHER

Autologous Treg: 2x10\^6/Kg

Interventions

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

Intervention Type: OTHER

Autologous Treg

Autologous Treg: 2x10\^6/Kg

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Xeno-life Science Ltd

UNKNOWN

Sponsor Role: collaborator

Wei Wang,MD

OTHER

Sponsor Role: lead

Responsible Party

Wei Wang,MD

Director of Cell Transplantation and Gene Therapy Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wei Wang, PHD,MD

Role: STUDY_CHAIR

Cell transplantation and gene therapy, the 3rd Xiangya hospital of Central South University

Locations

Cell Transplantation and Gene Therapy Institute

Changsha, Hunan, China

Countries

China

Other Identifiers

CellTransplant&GeneTherapy2013

Identifier Type: -

Identifier Source: org_study_id