Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell with self-and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures in patients liver cirrhosis will be evaluated.

Condition or disease	Intervention/treatment	Phase
Other Surgical Procedures	Procedure: stem cell transplantation through interventional procedures	Phase 2; Phase 3

Detailed Description:

This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	75 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
Study Start Date :	December 2011
Estimated Primary Completion Date :	December 2012
Estimated Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: stem cell transplantation therapy; umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.	Procedure: stem cell transplantation through interventional procedures; one time interventional procedures; Other Name: umbilical cord mesenchyma stem cell transplantation

Outcome Measures

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Primary Outcome Measures :

1. liver volume calculated by MRI [ Time Frame: 3 days before transplantation, 6 and 12 months after transplantation ]
   Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

Secondary Outcome Measures :

1. liver biopsy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ]
   The result of liver biopsy judged by the expert.
2. gastroscopy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ]
   Observe and photograph the related varicose veins.
3. blood biochemistry [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
   1. alanine aminotransferase
   2. aspartate aminotransferase
   3. gamma-glutamyltransferase(GGT)
   4. alkaline phosphatase
   5. total bilirubin
   6. direct bilirubin
   7. The total bile acid (TBA)
   8. serum cholinesterase (CHE)
   9. total cholesterol (TC)
   10. albumin
   11. the proportion of white balls
4. blood test [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
   1. platelet count (PLT)
   2. mean platelet volume (MPV)
   3. platelet distribution width (PDW)
   4. platelet hematocrit (PCT)
   5. alpha feto protein(AFP)
5. liver enzyme fiber spectrum [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
   1. laminin (LN)
   2. Ⅳ collagen detection (CIV)
   3. hyaluronic acid (HA)
   4. procollagen Ⅲ(PC Ⅲ)
6. coagulation [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
   1. prothrombin time (PT)
   2. activated partial thromboplastin time (APTT)
   3. fibrinogen (FIB)
   4. thrombin time (TT)
7. portal vein and splenic vein measure [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
   1. Portal vein diameter (Dpv);
   2. Portal vein maximum velocity (Vmaxpv);
   3. Portal vein blood flow per minute (Qpv);
   4. The splenic vein diameter (Dsv);
   5. Splenic vein maximum flow velocity (Vmaxsv);
   6. Splenic vein blood flow per minute (Qsv).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Clinical diagnosis of liver cirrhosis;
• Without hepatic encephalopathy;
• No ascites or have easily dissipated ascites;
• Value of bilirubin is less than 100;
• Value of albumin is greater than 16 g / L;
• Prothrombin time is less than 21 seconds;

Exclusion Criteria:

• Severe cardiovascular disease, and immunocompromised patients;
• Patients with localized lesions affecting graft infection;
• Coagulation disorders;
• Liver nodules more than 2cm or Liver cancer

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
Yihua An	Recruiting
Beijing, China
Contact: Yihua An, doctor 0086-10-88276848 doctoran2010@hotmail.com

Sponsors and Collaborators

General Hospital of Chinese Armed Police Forces

Xinjiang Armed Police Corps Hospital

Taian Hospital of Traditional Chinese Medicine

Investigators

Study Director:	Yihua An	Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:	NCT01491165 History of Changes
Other Study ID Numbers:	2011-12-07 liver cirrhosis
First Posted:	December 13, 2011
Last Update Posted:	October 26, 2012
Last Verified:	October 2012

Keywords provided by General Hospital of Chinese Armed Police Forces:

umbilical cord mesenchyma stem cell

Additional relevant MeSH terms:

Liver Cirrhosis; Liver Diseases; Digestive System Diseases