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Safety and Efficacy Study of Islets Xenotransplantation

NCT03162237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-06-02

No results posted yet for this study

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

Interventions

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

OTHER

Autologous Treg

Autologous Treg: 2x10\^6/Kg

Sponsors & Collaborators

  • Hunan Xeno-life Science Ltd

    collaborator UNKNOWN

  • Wei Wang,MD

    lead OTHER

Principal Investigators

  • Wei Wang, PHD,MD · Cell transplantation and gene therapy, the 3rd Xiangya hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162237 on ClinicalTrials.gov