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Completed

NCT Number: NCT01342250

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Shanghai, Shanghai Municipality, 200235, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional therapy plus low dose hUC-MSCs treatment

Biological

patients will receive the conventional therapy plus low dose hUC-MSCs treatment

conventional therapy plus medium dose hUC-MSCs treatment

Biological

patients will receive conventional therapy plus medium dose hUC-MSCs treatment

conventional therapy plus high dose hUC-MSCs treatment

Biological

patients will receive conventional therapy plus high dose hUC-MSCs treatment

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 1 year after treatment

Secondary outcomes

  1. Liver function improvement

    Time frame: 1 year after treatment

  2. The size of liver and the width of portal venous

    Time frame: 1 year after treatment

  3. Incidence of hepatocellular carcinoma within 1 year

    Time frame: 1 year after treatment

  4. Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)

    Time frame: 1 year after treatment

  5. The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )

    Time frame: 1 year after treatment

Sponsors and collaborators

Lead sponsor

Shenzhen Beike Bio-Technology Co., Ltd.

Industry

Collaborators

  • No.85 Hospital, Changning, Shanghai, China

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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