Safety and Efficacy of Human Mesenchymal Stem Cells for Treatment of Liver Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Beijing 302 Hospital
Sponsor:
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital
ClinicalTrials.gov Identifier:
NCT01218464
First received: October 8, 2010
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with LF will undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these patients.


Condition Intervention Phase
Liver Failure
Mesenchymal Stem Cells
Drug: Conventional plus MSC treatment
Drug: Conventional plus pacebo treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Phase Ⅰ/Ⅱ Study of Human Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) for Treatment of Liver Failure

Resource links provided by NLM:


Further study details as provided by Beijing 302 Hospital:

Primary Outcome Measures:
  • The levels of serum Total Protein and Albumin [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The levels of serum Total Bilirubin and Direct Bilirubin [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
  • The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Cholinesterase (CHE) [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
  • The level of alpha-fetoprotein (AFP) [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
  • The content of ascites [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
  • Survival rate and time [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
  • Body temperature, tetter and allergy [ Time Frame: Between 0 to 24 hours after UC-MSCs transfusion ] [ Designated as safety issue: Yes ]
  • The levels of Prothrombin Activity (PA) and Prothrombin Time (PT) [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
  • The score for Model for End-Stage Liver Disease [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional plus MSC treatment
Participants will receive conventional treatment plus a dose of MSC from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit
Drug: Conventional plus MSC treatment
Participants received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 12 weeks.
Other Name: Conventional plus MSC treatment
Experimental: Conventional plus pacebo treatment
Participants will receive conventional plus placebo treatment from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit
Drug: Conventional plus pacebo treatment
Participants received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
Other Name: Conventional plus pacebo treatment

Detailed Description:

Liver failure (LF) is a severe life-threatening condition, and is a dramatic clinical syndrome with massive necrosis of liver cells, and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Since current therapeutic options for LF that is usually with extremely poor prognosis are still limited, recent studies indicate that mesenchymal stem cells (MSCs), due to their function in immune modulation and liver-damage repair, are of great therapeutic potential for this disease. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration.The purpose of this study is to investigate the safety and initial efficacy of human umbilical cord MSC (UC-MSCs) treatment for patients with LF. In this study, MSCs were isolated from umbilical cord and generated in appropriate growth medium. 50 LF patients with LF received i.v. transfusion of 0.5-1.0×106 cells/kg of MSCs as the treated group and other 20 LF patients with LF were transfused with placebo without MSCs as control group. All 70 of them received the routine management for liver failure. During the 2-year follow up, the evaluation of safty and efficacy will be undergone to help to establish innovative cell-based therapies for the treatment of diseases.

  Eligibility

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

Inclusion Criteria:

  1. Aged 18-70 years
  2. Liver failure
  3. Negative pregnancy test (female patients in fertile age)
  4. Written consent

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignancies
  2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
  3. Pregnant or lactating women
  4. Severe bacteria infection
  5. Anticipated with difficulty of follow-up observation
  6. Other candidates who are judged to be not applicable to this study by doctors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218464

Contacts
Contact: Fu-Sheng Wang, Professor 86-10-63879735 ext 2015.12 fswang@public.bta.net.cn

Locations
China, Beijing
Beijing 302 Hospital Recruiting
Beijing, Beijing, China, 100039
Contact: Ming Shi, Professor    86-10-63879735 ext 2015.12    shiming302@sina.com   
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
Principal Investigator: Fu-Sheng Wang, Professor Beijing 302 Hospital
  More Information

Publications:
Responsible Party: Fu-Sheng Wang, Director, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT01218464     History of Changes
Other Study ID Numbers: Beijing302-003
Study First Received: October 8, 2010
Last Updated: May 30, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing 302 Hospital:
Liver Failure
Mesenchymal Stem Cells
Model for End-Stage Liver Disease
Ascite
Serum Albumin

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014