Mesenchymal Stem Cell Therapy for Liver Cirrhosis

March 15, 2021 updated by: Stem Med Pte. Ltd.

Mesenchymal Stem Cell Therapy for Liver Cirrhosis: A Phase I/II Study

MSCs have been studied for the treatment of liver diseases as well as non-liver diseases. MSCs have been successful in treating conditions like acute steroid-resistant GVHD in hematopoietic stem cell transplanted patients and also have shown to improve the MELD score in end-stage liver disease. There were no severe side effects observed in using autologous MSCs as a treatment option. The outcome of the studies done so far have been positive and it is encouraged to study the use of MSCs as cell therapy for treating liver diseases.

The estimated rate of cirrhosis in HBV patients in Singapore is about 1.6% per year, rate of hepatocellular carcinoma is about 0.8% per year overall and 3.0% per year in cirrhotic patients. Knowing that there are not many options currently available for Liver Cirrhosis patients and that they have a poor prognosis with an average life expectancy of < 12 months, this study uses autologous MSCs to treat Liver Cirrhosis patients in Singapore. The objective of the study is to demonstrate that autologous bone marrow is safe to be used in patients with liver cirrhosis as well as demonstrate that bone marrow MSC may improve liver function and prolong patient survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Liver cirrhosis refers to extreme scarring of the liver, resulting in suboptimal function of the liver. It can result from a variety of causes, ranging from hepatitis B and C infection, excessive alcohol consumption, autoimmune causes, fatty liver and others. Irrespective of the cause, once the liver becomes cirrhotic, it is a downhill course.

Liver cirrhosis is irreversible and most patients will progressively worsen over time. Once liver cirrhosis has reached the stage of decompensation, that is, development of jaundice, ascites, variceal bleeding, hepatic encephalopathy and coagulopathy the two-year survival drops to about 50%.

The definitive treatment of decompensated cirrhosis is liver transplantation. While a liver transplantation is potentially curative, the high costs, lack of a donor, treatment-related mortality and the immunosuppression complications make this option possible only for a limited number of patients. The vast majority do not have an effective option at all, thus the need to develop alternative therapies. Various types of Stem Cells had been investigated as a regenerative therapy for liver cirrhosis. These stem cells include bone marrow mesenchymal stem cells (MSC), bone marrow mononuclear cells (MNC) and peripheral CD34 positive cells. Some early studies have shown encouraging results in patients who had autologous bone marrow stem cell transplantation. There was improved liver function in these patients with cirrhotic livers.

The sponsor is proposing a study to look into the role of MSC therapy for patients with liver cirrhosis in Singapore. This will be a Phase I/II study with the main emphasis on the safety profile first. The trial will be conducted in compliance with the protocol, GCP and local regulatory requirement(s).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 258500
        • Recruiting
        • Asian American Liver Centre - Gleneagles Hospital (Annexe Block)
        • Contact:
        • Principal Investigator:
          • Lee Kang Hoe
      • Singapore, Singapore, 258500
        • Recruiting
        • Parkway Cancer Centre - Gleneagles Hospital
        • Contact:
        • Principal Investigator:
          • Teo Cheng Peng
      • Singapore, Singapore, 329563
        • Recruiting
        • Desmond Wai Liver & Gastrointestinal Disease Centre - Mount Elizabeth Novena Specialist Centre
        • Contact:
        • Principal Investigator:
          • Wai Chun Tao, Desmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all the inclusive criteria to participate in the study:

  1. with definite liver cirrhosis, irrespective of aetiology
  2. must have Child's B or C stage
  3. must have signed an informed consent form

Exclusion Criteria:

Subjects with any of the following criteria are regarded as an exclusion from the study and will not be permitted to participate:

  1. age ≤21 years and >70 years old
  2. with life expectancy of < 6 months
  3. cancers and bone marrow malignancies
  4. patients with an active infection or multiple infections
  5. patients with uncontrolled hypertension and diabetes
  6. immunosuppressed patients (IST must have stopped at least 4 weeks prior to trial enrolment)
  7. patients who are HIV positive
  8. patients who are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Arm
A single dose of 0.5 to 1 x 10^6/kg autologous BM MSCs (Total volume: 30 - 50 ml) will be infused via peripheral venous access.
Biological: Autologous BM MSC
A total of 100-200ml will be harvested from the subject, in either a single or multiple punctures. This will be processed for autologous MSC infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Examination
Time Frame: Up to 34 weeks

To observe for the following:

  • absence of grade IV anaphylactic reactions (in reference to CTCAE 4.03)
  • absence of grade IV febrile reactions or septic/ infective complications (in reference to CTCAE 4.03).
Up to 34 weeks
MR Elastography
Time Frame: Up to 34 weeks
To detect liver stiffness
Up to 34 weeks
The level of serum alanine aminotransferase (ALT)
Time Frame: Up to 34 weeks
To ensure the absence of deterioration of liver function.
Up to 34 weeks
The level of glomerular filtration rate (GFR)
Time Frame: Up to 34 weeks
To ensure the absence of deterioration of renal function.
Up to 34 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of serum prothrombin time (PT)
Time Frame: Up to 6 months, post-infusion
To assess the efficacy of treatment
Up to 6 months, post-infusion
The level of serum total bilirubin (TB)
Time Frame: Up to 6 months, post-infusion
To assess the efficacy of treatment
Up to 6 months, post-infusion
The level of serum albumin (ALB)
Time Frame: Up to 6 months, post-infusion
To assess the efficacy of treatment
Up to 6 months, post-infusion
MELD Score
Time Frame: Up to 6 months, post-infusion
To assess the efficacy of treatment
Up to 6 months, post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Med Pte. Ltd.

Collaborators

Parkway Cancer Centre
Asian American Liver Centre
Desmond Wai Liver & Gastrointestinal Diseases Centre

Investigators

  • Principal Investigator: Teo Cheng Peng, Parkway Cancer Centre
  • Principal Investigator: Wai Chun Tao, Desmond, Desmond Wai Liver & Gastrointestinal Diseases Centre
  • Principal Investigator: Lee Kang Hoe, Asian American Liver Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 18, 2018

Primary Completion (ANTICIPATED)

October 22, 2021

Study Completion (ANTICIPATED)

October 22, 2021

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (ACTUAL)

August 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-SM-L0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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