Safety of UC-MSC Transfusion for ACLF Patients

NCT04822922 | Unknown Phase 2

• 1 other identifier: MSC-ACLF-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Acute on chronic liver failure (ACLF) is a type of critically ill liver disease with high short-term mortality in liver disease. Liver transplantation is currently the only method to improve survival. Current clinical research evidence shows that mesenchymal stem cells can reduce the mortality of ACLF patients and are safe. This study aims to explore the safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of ACLF. The study population is ACLF patients with 1-2 organ failures. To explore the safety of 3 doses of UC-MSCs, 16 patients need to be enrolled. The main observation indicators are the short-term and long-term safety of the treatment. All patients need to receive the standard medical treatment (SMT) at the same time. Stem cell treatment is given by intravenous infusion on the first, fourth, seventh, and tenth day. The occurrence of adverse events (AE) and serious adverse events(SAE) before and after the infusion will be observed. After the patient is discharged from the hospital, patients will be followed , the follow-up time is 5 years.

Conditions

Acute-On-Chronic Liver Failure

Keywords

ACLF; mesenchymal stem cell; safety

Outcome Measures

Primary Outcomes (1)

• Safety of treatment

  The purpose of this trial is to observe the short-term safety of low, medium and high doses of hUC-MSCs in the treatment of ACLF patients. The primary endpoint of the study was serious adverse events that occurred during the course of one month of treatment. If serious adverse reactions(SAE) occur during the treatment in hospital, the intervention will be stopped and the study will be terminated.

  1 month since intervention start

Secondary Outcomes (1)

• Short-time efficacy of treatment

  90 days

Study Arms (3)

low dose

EXPERIMENTAL

hUC-MSCs 4\*10\^5/kg/each time

Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)

middle dose

EXPERIMENTAL

hUC-MSCs 8\*10\^5/kg/each time

Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)

high dose

EXPERIMENTAL

hUC-MSCs 12\*10\^5/kg/each time

Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)

Interventions

Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) GENETIC

The hUC-MSCs were injected intravenously on the 1, 4, 7 and 10 days after patients recruitment. The treatment doses include low dose: 4\*10\^5 cells/kg/each time, and medium dose: 8\*10\^5 cells/kg/each time, high dose 12\*10\^5 cells/kg/each time. After 3 groups of patients were enrolled, the group with appropriate safety and effectiveness was selected and the other 4 subjects were included.

high dose; low dose; middle dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old;
• A history of chronic liver disease, chronic acute liver failure (ACLF) caused by various causes, 1-2 organ failure (ACLF diagnosis is based on the European EASL diagnostic criteria, and the organ failure criteria is based on CLIF-OF);
• The patient or adult family members agree to participate in this study and sign an informed consent form;

You may not qualify if:

• Those who meet any of the following conditions will not be included:
• Those who intend to undergo artificial liver treatment;
• Those who have received liver transplantation and any form of stem cell therapy;
• Malignant tumors in or outside the liver; or imaging findings suggest malignant mass in the liver or tuberculosis;
• Complicated with severe autoimmune diseases; combined with severe cardiopulmonary insufficiency; renal replacement therapy; Immunosuppressive therapy; HIV/tuberculosis infection; alcohol/drug addiction; participated in drug trials in the past 3 months;
• Gastrointestinal bleeding or serious infection occurred in the past one month;
• Pregnant and lactating women;
• Those who do not have the ability to make independent judgments and have no direct adult family members to sign the informed consent form.

Sponsors & Collaborators

• Hai Li: lead

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity,

Shanghai, Shanghai Municipality, China

Location

Related Publications (16)

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MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Hai Li

  Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Hai Li

CONTACT

+86-13818525494; haili＿17@126.cpm

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician of gastroenterological division

Model Details: 3 parallel group with different doses of UC-MSC

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: September 30, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 21, 2024
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)