Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis

Autoimmune Diseases Clinical Trial

— Treg  

Official title:

Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune Hepatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02704338
• Other study ID #: NJLT002
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: February 28, 2016
• Last updated: March 4, 2016
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: March 2016
• Source: Nanjing Medical University
• Contact: Ling Lu, M.D.,PH.D.
• Phone: 86-25-68136053
• Email: lvling[@]njmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The trial will be carried out in autoimmune patients. The investigators will isolate CD4(cluster of differentiation)+CD25(cluster of differentiation25)+CD127(cluster of differentiation127)- Tregs from these patients, and expand them with IL(interleukin)-2 retinoid acid and anti-CD3(cluster of differentiation 3) /CD28(cluster of differentiation 28) beads. The patients will be subsequently treated with single infusion of CD4+CD25+CD127- Tregs (10-20 x 106 cells/kg).

In the clinical trials, the investigators will monitor the number of Tregs in patients at different periods, and to test their suppressive functions in vitro. Also the function and biopsy of liver will be processed to determine the efficacy of Treg therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written informed consent

2. Autoimmune hepatitis(according to the criteria defined by the international autoimmune hepatitis Group ,Hepatology, 2008;48:169-176)

3. Negative pregnancy test

4. Moderately active disease under standard treatment

Exclusion Criteria:

1. Hepatocellular carcinoma or other Malignancies

2. Pregnant or lactating women

3. Vital organs failure (Cardiac, Renal or Respiratory, et al)

4. Sepsis

5. Active thrombosis in the portal or hepatic veins

6. 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

7. Surgery during the last 2 months or surgery planned during the study,

8. Participation in other biomedical research in the last 3 months or planned during the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Hepatitis, Autoimmune

Intervention

Biological:
• Regulatory T cells
Regulatory t cells will be injected back to autoimmune hepatitis patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges)		12 months	Yes
Primary	immunology remission(=serum levels of T cell subsets, immune globulin, and complement within normal ranges) and lack of other side effects.		12 months	Yes
Secondary	Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin.		12 months	No
Secondary	Suspected rejection detected by clinical feature or biopsy.		12 months	No
Secondary	Incidence of 2 times increase of immunology related level(serum levels of T cell subsets,immune globulin) or present other side effects.		12 months	No