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Mesenchymal Stem Cell Therapy for Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03626090
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Parkway Cancer Centre
Asian American Liver Centre
Desmond Wai Liver & Gastrointestinal Diseases Centre
Information provided by (Responsible Party):
Stem Med Pte. Ltd.

Brief 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.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: Autologous BM MSC Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.
Masking: None (Open Label)
Masking Description: N.A.
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Therapy for Liver Cirrhosis: A Phase I/II Study
Actual Study Start Date : August 18, 2018
Estimated Primary Completion Date : October 22, 2020
Estimated Study Completion Date : October 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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.




Primary Outcome Measures :
  1. 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).

  2. MR Elastography [ Time Frame: Up to 34 weeks ]
    To detect liver stiffness

  3. The level of serum alanine aminotransferase (ALT) [ Time Frame: Up to 34 weeks ]
    To ensure the absence of deterioration of liver function.

  4. The level of glomerular filtration rate (GFR) [ Time Frame: Up to 34 weeks ]
    To ensure the absence of deterioration of renal function.


Secondary Outcome Measures :
  1. The level of serum prothrombin time (PT) [ Time Frame: Up to 6 months, post-infusion ]
    To assess the efficacy of treatment

  2. The level of serum total bilirubin (TB) [ Time Frame: Up to 6 months, post-infusion ]
    To assess the efficacy of treatment

  3. The level of serum albumin (ALB) [ Time Frame: Up to 6 months, post-infusion ]
    To assess the efficacy of treatment

  4. MELD Score [ Time Frame: Up to 6 months, post-infusion ]
    To assess the efficacy of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626090


Contacts
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Contact: Aisha Rilvan 63699191 aisharilvan@stem-med.sg

Locations
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Singapore
Asian American Liver Centre - Gleneagles Hospital (Annexe Block) Recruiting
Singapore, Singapore, 258500
Contact: Aisha Rilvan    63699191    aisharilvan@stem-med.sg   
Principal Investigator: Lee Kang Hoe         
Parkway Cancer Centre - Gleneagles Hospital Recruiting
Singapore, Singapore, 258500
Contact: Aisha Rilvan    63699191    aisharilvan@stem-med.sg   
Principal Investigator: Teo Cheng Peng         
Desmond Wai Liver & Gastrointestinal Disease Centre - Mount Elizabeth Novena Specialist Centre Recruiting
Singapore, Singapore, 329563
Contact: Aisha Rilvan    63699191    aisharilvan@stem-med.sg   
Principal Investigator: Wai Chun Tao, Desmond         
Sponsors and Collaborators
Stem Med Pte. Ltd.
Parkway Cancer Centre
Asian American Liver Centre
Desmond Wai Liver & Gastrointestinal Diseases Centre
Investigators
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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:
Neagu M, Suciu E, Ordodi V, Unescu VP. Human Mesenchymal Stem Cells As Basic Tools for Tissue Engineering : Isolation and Culture. October. 2005;15(October):29-34.

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Responsible Party: Stem Med Pte. Ltd.
ClinicalTrials.gov Identifier: NCT03626090     History of Changes
Other Study ID Numbers: P-SM-L0001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stem Med Pte. Ltd.:
Liver
Cirrhosis
Stem Cell
Cell Therapy
Child B
Child C
Advance
Advanced
Singapore
MSC
Mesenchymal
MSC Therapy
Treatment
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases