Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis - Full Text View

Sponsor:	Shenzhen Beike Bio-Technology Co., Ltd.
Collaborator:	Shanghai 85 Hospital
Information provided by (Responsible Party):	Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01342250

Purpose

Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

Condition	Intervention	Phase
Liver Cirrhosis	Biological: conventional therapy plus low dose hUC-MSCs treatment Biological: conventional therapy plus medium dose hUC-MSCs treatment Biological: conventional therapy plus high dose hUC-MSCs treatment	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by Shenzhen Beike Bio-Technology Co., Ltd.:

Primary Outcome Measures:

Overall Survival (OS) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Liver function improvement [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
The size of liver and the width of portal venous [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
Incidence of hepatocellular carcinoma within 1 year [ Time Frame: 1 year after treatment ] [ Designated as safety issue: Yes ]
Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al ) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	October 2010
Study Completion Date:	October 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Conventional plus hUC-MSCs treatment (low dose)	Biological: conventional therapy plus low dose hUC-MSCs treatment patients will receive the conventional therapy plus low dose hUC-MSCs treatment
Experimental: conventional therapy plus hUC-MSCs treatment （medium dose）	Biological: conventional therapy plus medium dose hUC-MSCs treatment patients will receive conventional therapy plus medium dose hUC-MSCs treatment
Experimental: conventional therapy plus hUC-MSCs treatment （high dose）	Biological: conventional therapy plus high dose hUC-MSCs treatment patients will receive conventional therapy plus high dose hUC-MSCs treatment

Detailed Description:

To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent.
Aged 18-70 years.
Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
Expecting lifetime is over 2 months.
Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.

Exclusion Criteria:

Severe drug allergic history or anaphylaxis.
Severe problems in other vital organs(e.g. the heart, renal or lungs)
Severe problems in psychiatric disease,such as Schizophrenia,et al
Severe bacteria infection.
Malignancies.
Alcoholism or drug abuse.
Plan to have liver transplantation in 3 months.
Pregnancy
Candidates who are participating in other study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342250

Locations

China, Shanghai
Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)
Shanghai, Shanghai, China, 200235

Sponsors and Collaborators

Shenzhen Beike Bio-Technology Co., Ltd.

Shanghai 85 Hospital

Investigators

Principal Investigator:

Chengwei Chen

Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)

More Information

No publications provided

Responsible Party:	Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01342250 History of Changes
Other Study ID Numbers:	BKCR-LD-1.0(2010)
Study First Received:	April 21, 2011
Last Updated:	October 13, 2011
Health Authority:	China: Ministry of Health

Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:

Decompensated Liver Cirrhosis
Umbilical Cord Mesenchymal Stem Cells

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012