NCT03162237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

5.4 years

First QC Date

January 29, 2014

Last Update Submit

May 29, 2020

Conditions

Type 1 Diabetes

Keywords

Type1 diabetesporcine isletstreg cellsimmunosuppressxenotransplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Porcine C-peptide

    1 years

  • Hemoglobin A1c

    1 years

  • AST

    1 years

  • ALT

    1 years

  • Scr

    1 years

  • +6 more secondary outcomes

Study Arms (2)

Porcine islets and autologous treg

EXPERIMENTAL

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

Other: Porcine isletsOther: Autologous Treg

AutologousTreg

ACTIVE COMPARATOR

Autologous Treg:2x10\^6/Kg

Other: Autologous Treg

Interventions

Porcine isletsOTHER

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

Porcine islets and autologous treg
Autologous TregOTHER

Autologous Treg: 2x10\^6/Kg

AutologousTregPorcine islets and autologous treg

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Transplantation and Gene Therapy Institute

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Wei Wang, PHD,MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Cell Transplantation and Gene Therapy Institute

Study Record Dates

First Submitted

January 29, 2014

First Posted

May 22, 2017

Study Start

July 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)