Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-18
Study Completion Date
2021-10-22
Brief Summary
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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.
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.
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Detailed Description
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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).
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).
Conditions
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Liver Cirrhosis
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Autologous BM MSC
Intervention Type
BIOLOGICAL
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.
Interventions
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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.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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
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
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
Minimum Eligible Age
21 Years
Maximum Eligible Age
69 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Parkway Cancer Centre
UNKNOWN
Sponsor Role
collaborator
Asian American Liver Centre
UNKNOWN
Sponsor Role
collaborator
Desmond Wai Liver & Gastrointestinal Diseases Centre
UNKNOWN
Sponsor Role
collaborator
Stem Med Pte. Ltd.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Teo Cheng Peng
Role: PRINCIPAL_INVESTIGATOR
Parkway Cancer Centre
Wai Chun Tao, Desmond
Role: PRINCIPAL_INVESTIGATOR
Desmond Wai Liver & Gastrointestinal Diseases Centre
Lee Kang Hoe
Role: PRINCIPAL_INVESTIGATOR
Asian American Liver Centre
Locations
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Asian American Liver Centre - Gleneagles Hospital (Annexe Block)
Singapore, , Singapore
Site Status
RECRUITING
Parkway Cancer Centre - Gleneagles Hospital
Singapore, , Singapore
Site Status
RECRUITING
Desmond Wai Liver & Gastrointestinal Disease Centre - Mount Elizabeth Novena Specialist Centre
Singapore, , Singapore
Site Status
RECRUITING
Countries
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Singapore
Central Contacts
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Facility Contacts
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References
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Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P-SM-L0001
Identifier Type: -
Identifier Source: org_study_id
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