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Mesenchymal Stem Cell Therapy for Liver Cirrhosis

NCT03626090 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Parkway Cancer Centre

    collaborator UNKNOWN

  • Asian American Liver Centre

    collaborator UNKNOWN

  • Desmond Wai Liver & Gastrointestinal Diseases Centre

    collaborator UNKNOWN

  • Stem Med Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Teo Cheng Peng · Parkway Cancer Centre

  • Wai Chun Tao, Desmond · Desmond Wai Liver & Gastrointestinal Diseases Centre

  • Lee Kang Hoe · Asian American Liver Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-18
Primary Completion
2021-10-22
Completion
2021-10-22

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03626090 on ClinicalTrials.gov