NCT02704338

Brief Summary

Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2016

Typical duration for phase_1

Status
unknown

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

First Submitted

Initial submission to the registry

February 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

February 28, 2016

Last Update Submit

March 4, 2016

Conditions

Autoimmune Diseases

Keywords

Autoimmune Diseases, Treg

Outcome Measures

Primary Outcomes (2)

  • Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges)

    12 months

  • immunology remission(=serum levels of T cell subsets, immune globulin, and complement within normal ranges) and lack of other side effects.

    12 months

Secondary Outcomes (3)

  • Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin.

    12 months

  • Suspected rejection detected by clinical feature or biopsy.

    12 months

  • Incidence of 2 times increase of immunology related level(serum levels of T cell subsets,immune globulin) or present other side effects.

    12 months

Study Arms (1)

Regulatory T cells

EXPERIMENTAL

CD4(cluster of differentiation)+CD25+CD127- T cells isolated from peripheral blood mononuclear cells were be expanded with GMP(Good Manufacturing Practice) anti-CD3/CD28 coated beads in the presence of IL-2 and all-trans retinoid acid.

Biological: Regulatory T cells

Interventions

Regulatory T cellsBIOLOGICAL

Regulatory t cells will be injected back to autoimmune hepatitis patients

Regulatory T cells

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Autoimmune hepatitis(according to the criteria defined by the international autoimmune hepatitis Group ,Hepatology, 2008;48:169-176)
  • Negative pregnancy test
  • Moderately active disease under standard treatment

You may not qualify if:

  • Hepatocellular carcinoma or other Malignancies
  • Pregnant or lactating women
  • Vital organs failure (Cardiac, Renal or Respiratory, et al)
  • Sepsis
  • Active thrombosis in the portal or hepatic veins
  • Concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent
  • Surgery during the last 2 months or surgery planned during the study,
  • Participation in other biomedical research in the last 3 months or planned during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.

    PMID: 35179437DERIVED

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Hong Wang, M.D.,PH.D.

    Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Ling Lu, M.D.,PH.D.

CONTACT

86-25-68136053lvling@njmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2016

First Posted

March 10, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

October 1, 2018

Last Updated

March 10, 2016

Record last verified: 2016-03