Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease

NCT03460795 | Unknown Phase 1

• 1 other identifier: NJLT005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a diffuse liver lesion caused by one or more causes over a long period of time or repeatedly. Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become hard. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as liver injury and liver fibrosis displayed good tolerance and efficiency. Besides, regulatory T cells(Tregs) had been proved as an immune regualtory T cell subsets, which could reduce immune cell activation and reduce liver injury severity. The purpose of this study is to learn whether and how MSCs and Tregs can improve the disease conditions in patients with decompensated cirrhosis.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (8)

• Albumin (ALB)

  The evaluation of serum levels of ALB

  24 months

• Alanine aminotransferase (ALT)

  The evaluation of serum levels of ALT

  24 months

• Prealbumin (PA)

  The evaluation of serum levels of PA

  24 months

• Total bilirubin (TB)

  The evaluation of serum levels of TB

  24 months

• Direct bilirubin (DB)

  The evaluation of serum levels of DB

  24 months

• Blood urea nitrogen (BUN)

  The evaluation of serum levels of BUN

  24 months

• Uric acid (UA)

  The evaluation of serum levels of UA

  24 months

• Serum creatinine (Scr)

  The evaluation of serum levels of Scr

  24 months

Secondary Outcomes (3)

• Child-Pugh

  24 months

• Model for end-stage liver disease (MELD)

  24 months

• Quality of life (QOL)

  24 months

Other Outcomes (1)

• Evaluation of liver fibrosis

  24 months

Study Arms (1)

Conventional plus MSC and Tregs treatment

EXPERIMENTAL

Biological: MSC and Tregs

Interventions

MSC and Tregs BIOLOGICAL

conventional plus MSC and Tregs or placebo treatment

Conventional plus MSC and Tregs treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed as decompensated liver cirrhosis.
• Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below Detection Level over six mouths, and the liver function remained below Child-pugh A grade or MELD score \>10.
• Other causes of cirrhosis, liver function compensatory incomplete. In the past year, despite active medical treatment taken, the condition has continued to increase, at least because of cirrhosis complications such as ascites, spontaneous peritonitis, gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time.
• Need to intermittently supplement albumin and apply diuretic therapy.
• Albumin \<35 g/L, total bilirubin \<170 umol/L, prothrombin activity\> 30%; (Prothrombin time \<20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic encephalopathy (grade II or lower), Child-pugh score\> 5 points).
• There was no history of gastrointestinal hemorrhage within the last month and population with no high-risk portal hypertension and gastrointestinal bleeding was evaluated recently.
• Unconditional acceptance of orthotopic liver transplantation.
• Aged from 18 to 65 years.
• Voluntarily signed informed consent form.

You may not qualify if:

• A malignant tumor with liver or other organs or a history of previous cancer.
• Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
• Patients with severe heart, lung, kidney or blood system diseases and failure status.
• Pregnant or lactating women.
• Allergic constitution.
• There is a history of alcohol abuse, drug abuse, and failure to effectively quit.
• Patients did not participate in other clinical trials within 4 weeks.
• Any condition, investigator believe that patients should not participate in this study.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinhai Tang, M.D, PH.D

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Ling Lu, M.D, PH.D

CONTACT

86-025-68136053; lvling@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 23, 2018
• First Posted: March 9, 2018
• Study Start: June 1, 2020
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

CN (1)