Mesenchymal Stem Cell Therapy for Liver Cirrhosis

NCT03626090 | Unknown Phase 1 DMC

• 1 other identifier: P-SM-L0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Cirrhosis

Keywords

Liver; Cirrhosis; Child B; Child C; Advance; Advanced; Singapore; MSC; Mesenchymal; Stem Cell; Cell Therapy; MSC Therapy; Treatment

Outcome Measures

Primary Outcomes (4)

• 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

• MR Elastography

  To detect liver stiffness

  Up to 34 weeks

• The level of serum alanine aminotransferase (ALT)

  To ensure the absence of deterioration of liver function.

  Up to 34 weeks

• The level of glomerular filtration rate (GFR)

  To ensure the absence of deterioration of renal function.

  Up to 34 weeks

Secondary Outcomes (4)

• The level of serum prothrombin time (PT)

  Up to 6 months, post-infusion

• The level of serum total bilirubin (TB)

  Up to 6 months, post-infusion

• The level of serum albumin (ALB)

  Up to 6 months, post-infusion

• MELD Score

  Up to 6 months, post-infusion

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

Autologous BM MSC 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.

Treatment Arm

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the inclusive criteria to participate in the study:
• with definite liver cirrhosis, irrespective of aetiology
• must have Child's B or C stage
• must have signed an informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Stem Med Pte. Ltd.: lead
• Parkway Cancer Centre: collaborator
• Asian American Liver Centre: collaborator
• Desmond Wai Liver & Gastrointestinal Diseases Centre: collaborator

Study Sites (3)

Asian American Liver Centre - Gleneagles Hospital (Annexe Block)

Singapore, 258500, Singapore

RECRUITING

Parkway Cancer Centre - Gleneagles Hospital

Singapore, 258500, Singapore

RECRUITING

Desmond Wai Liver & Gastrointestinal Disease Centre - Mount Elizabeth Novena Specialist Centre

Singapore, 329563, Singapore

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Department

CONTACT

63699191; clinicaltrials@stem-med.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 10, 2018
• Study Start: August 18, 2018
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)