Liver Cirrhosis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | October 22, 2021 |
Est. primary completion date | October 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 69 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Asian American Liver Centre - Gleneagles Hospital (Annexe Block) | Singapore | |
Singapore | Desmond Wai Liver & Gastrointestinal Disease Centre - Mount Elizabeth Novena Specialist Centre | Singapore | |
Singapore | Parkway Cancer Centre - Gleneagles Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Stem Med Pte. Ltd. | Asian American Liver Centre, Desmond Wai Liver & Gastrointestinal Diseases Centre, Parkway Cancer Centre |
Singapore,
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* Note: There are 56 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Examination | 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 | |
Primary | MR Elastography | To detect liver stiffness | Up to 34 weeks | |
Primary | The level of serum alanine aminotransferase (ALT) | To ensure the absence of deterioration of liver function. | Up to 34 weeks | |
Primary | The level of glomerular filtration rate (GFR) | To ensure the absence of deterioration of renal function. | Up to 34 weeks | |
Secondary | The level of serum prothrombin time (PT) | To assess the efficacy of treatment | Up to 6 months, post-infusion | |
Secondary | The level of serum total bilirubin (TB) | To assess the efficacy of treatment | Up to 6 months, post-infusion | |
Secondary | The level of serum albumin (ALB) | To assess the efficacy of treatment | Up to 6 months, post-infusion | |
Secondary | MELD Score | To assess the efficacy of treatment | Up to 6 months, post-infusion |
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