Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342250
• Other study ID #: BKCR-LD-1.0(2010)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 21, 2011
• Last updated: October 13, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Shenzhen Beike Bio-Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Biological:
• conventional therapy plus low dose hUC-MSCs treatment
patients will receive the conventional therapy plus low dose hUC-MSCs treatment
• conventional therapy plus medium dose hUC-MSCs treatment
patients will receive conventional therapy plus medium dose hUC-MSCs treatment
• conventional therapy plus high dose hUC-MSCs treatment
patients will receive conventional therapy plus high dose hUC-MSCs treatment

Locations

Country	Name	City	State
China	Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Beike Bio-Technology Co., Ltd.	No.85 Hospital, Changning, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		1 year after treatment	No
Secondary	Liver function improvement		1 year after treatment	No
Secondary	The size of liver and the width of portal venous		1 year after treatment	No
Secondary	Incidence of hepatocellular carcinoma within 1 year		1 year after treatment	Yes
Secondary	Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)		1 year after treatment	No
Secondary	The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )		1 year after treatment	No