Other Surgical Procedures
Conditions
Keywords
umbilical cord mesenchyma stem cell
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.
Interventions
PROCEDUREstem cell transplantation through interventional procedures
one time interventional procedures
Sponsors
Xinjiang Armed Police Corps Hospital
Taian Hospital of Traditional Chinese Medicine
General Hospital of Chinese Armed Police Forces
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| liver volume calculated by MRI | 3 days before transplantation, 6 and 12 months after transplantation | Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gastroscopy | whinin 7 days before transplantation, 6 and 12 months after transplantation | Observe and photograph the related varicose veins. |
| blood biochemistry | 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 |
| blood test | 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) |
| liver biopsy | whinin 7 days before transplantation, 6 and 12 months after transplantation | The result of liver biopsy judged by the expert. |
| coagulation | 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) |
| portal vein and splenic vein measure | 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). |
| liver enzyme fiber spectrum | 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) |
Countries
China
Outcome results
None listed