Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis
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ClinicalTrials.gov Identifier: NCT01491165 |
Recruitment Status : Unknown
Verified October 2012 by General Hospital of Chinese Armed Police Forces.
Recruitment status was: Recruiting
First Posted : December 13, 2011
Last Update Posted : October 26, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Other Surgical Procedures | Procedure: stem cell transplantation through interventional procedures | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: stem cell transplantation therapy
umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
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Procedure: stem cell transplantation through interventional procedures
one time interventional procedures
Other Name: umbilical cord mesenchyma stem cell transplantation |
- 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.
- liver biopsy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ]The result of liver biopsy judged by the expert.
- gastroscopy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ]Observe and photograph the related varicose veins.
- blood biochemistry [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
- 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 [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
- platelet count (PLT)
- mean platelet volume (MPV)
- platelet distribution width (PDW)
- platelet hematocrit (PCT)
- alpha feto protein(AFP)
- liver enzyme fiber spectrum [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
- laminin (LN)
- Ⅳ collagen detection (CIV)
- hyaluronic acid (HA)
- procollagen Ⅲ(PC Ⅲ)
- coagulation [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
- prothrombin time (PT)
- activated partial thromboplastin time (APTT)
- fibrinogen (FIB)
- thrombin time (TT)
- portal vein and splenic vein measure [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
- 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).

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491165
China | |
Yihua An | Recruiting |
Beijing, China | |
Contact: Yihua An, doctor 0086-10-88276848 doctoran2010@hotmail.com |
Study Director: | Yihua An | Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force |
Responsible Party: | General Hospital of Chinese Armed Police Forces |
ClinicalTrials.gov Identifier: | NCT01491165 |
Other Study ID Numbers: |
2011-12-07 liver cirrhosis |
First Posted: | December 13, 2011 Key Record Dates |
Last Update Posted: | October 26, 2012 |
Last Verified: | October 2012 |
umbilical cord mesenchyma stem cell |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |