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Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

Primary Purpose

Liver Cirrhosis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Autologous BMSCs transplantation

Conserved therapy

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring BMSC, Stem cells, Liver cirrhosis, Transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18~60 years.
Serum HBsAg positive.
Ultrasonographic evidences of cirrhosis.

Exclusion Criteria:

history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
Prothrombin time is less than 30s.
Cirrhosis caused by other reasons except HBV infection.
Severe problems in other vital organs(e.g.the heart,renal or lungs).
Liver tumor on ultrasonography, CT or MRI examination.
Pregnant or lactating women.
Imaging evidences of vascular thromboses.

Sites / Locations

Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A(conserved therapy )

Group B (BMSC Transplantion)

Arm Description

Thirty of the enrolled patients were randomly assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Thirty of the enrolled patients were randomly assigned to Group B were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as Bone Mesenchymal Stem Cells(BMSC) transplantation via portal vein.

Outcomes

Primary Outcome Measures

The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement.

Secondary Outcome Measures

Full Information

NCT ID

NCT00993941

First Posted

October 13, 2009

Last Updated

December 3, 2010

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00993941

Brief Title

Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

Official Title

Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis

Keywords

BMSC, Stem cells, Liver cirrhosis, Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A(conserved therapy )

Arm Type

Active Comparator

Arm Description

Thirty of the enrolled patients were randomly assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Arm Title

Group B (BMSC Transplantion)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Autologous BMSCs transplantation

Intervention Description

10 ml autologous BMSCs(7~8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.

Intervention Type

Drug

Intervention Name(s)

Conserved therapy

Intervention Description

Oral or intravenous administration

Primary Outcome Measure Information:

Title

Time Frame

pre-transplantation, and 1week to 1 year post-transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18~60 years. Serum HBsAg positive. Ultrasonographic evidences of cirrhosis. Exclusion Criteria: history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. Prothrombin time is less than 30s. Cirrhosis caused by other reasons except HBV infection. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin B liang, MD/PHD

Organizational Affiliation

SunYat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

Learn more about this trial

Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

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