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

Primary Purpose

Other Surgical Procedures

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

stem cell transplantation through interventional procedures

About this trial

This is an interventional treatment trial for Other Surgical Procedures focused on measuring umbilical cord mesenchyma stem cell

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yihua AnRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell transplantation therapy

Arm Description

umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.

Outcomes

Primary Outcome Measures

liver volume calculated by MRI

Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

Secondary Outcome Measures

liver biopsy

The result of liver biopsy judged by the expert.

gastroscopy

Observe and photograph the related varicose veins.

blood biochemistry

alanine aminotransferase aspartate aminotransferase gamma-glutamyltransferase(GGT) alkaline phosphatase total bilirubin direct bilirubin The total bile acid (TBA) serum cholinesterase (CHE) total cholesterol (TC) albumin the proportion of white balls

blood test

platelet count (PLT) mean platelet volume (MPV) platelet distribution width (PDW) platelet hematocrit (PCT) alpha feto protein(AFP)

liver enzyme fiber spectrum

laminin (LN) Ⅳ collagen detection (CIV) hyaluronic acid (HA) procollagen Ⅲ(PC Ⅲ)

coagulation

prothrombin time (PT) activated partial thromboplastin time (APTT) fibrinogen (FIB) thrombin time (TT)

portal vein and splenic vein measure

Portal vein diameter (Dpv); Portal vein maximum velocity (Vmaxpv); Portal vein blood flow per minute (Qpv); The splenic vein diameter (Dsv); Splenic vein maximum flow velocity (Vmaxsv); Splenic vein blood flow per minute (Qsv).

Full Information

NCT ID

NCT01491165

First Posted

December 8, 2011

Last Updated

October 25, 2012

Sponsor

General Hospital of Chinese Armed Police Forces

Collaborators

Xinjiang Armed Police Corps Hospital, Taian Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01491165

Brief Title

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

Official Title

Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

General Hospital of Chinese Armed Police Forces

Collaborators

Xinjiang Armed Police Corps Hospital, Taian Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Surgical Procedures

Keywords

umbilical cord mesenchyma stem cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

stem cell transplantation therapy

Arm Type

Experimental

Arm Description

umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.

Intervention Type

Procedure

Intervention Name(s)

stem cell transplantation through interventional procedures

Other Intervention Name(s)

umbilical cord mesenchyma stem cell transplantation

Intervention Description

one time interventional procedures

Primary Outcome Measure Information:

Title

liver volume calculated by MRI

Description

Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

Time Frame

3 days before transplantation, 6 and 12 months after transplantation

Secondary Outcome Measure Information:

Title

liver biopsy

Description

The result of liver biopsy judged by the expert.

Time Frame

whinin 7 days before transplantation, 6 and 12 months after transplantation

Title

gastroscopy

Description

Observe and photograph the related varicose veins.

Time Frame

whinin 7 days before transplantation, 6 and 12 months after transplantation

Title

blood biochemistry

Description

Time Frame