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Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure


Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Both
Liver Failure

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Trial Information

Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure


Inclusion Criteria:



- Aged 18-65 years

- Liver failure

- Negative pregnancy test (female patients in fertile age)

- Written consent

- HBsAg positive

- TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,

- INR≥1.5 or 20%<PTA≤40%

- 17≤MELD score≤30

Exclusion Criteria:

- Hepatocellular carcinoma or other malignancies

- Severe problems in other vital organs(e.g.the heart,renal or lungs)

- Pregnant or lactating women

- Severe bacteria infection

- Anticipated with difficulty of follow-up observation

- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and
so on

- Other candidates who are judged to be not applicable to this study by doctors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

survival rate

Outcome Description:

The survival rate and time

Outcome Time Frame:

72 weeks

Safety Issue:

No

Principal Investigator

Qi Zhang, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Third Affiliated Hospital, Sun Yat-Sen University

Authority:

China: Ministry of Health

Study ID:

The Third Affiliated Hospital

NCT ID:

NCT01844063

Start Date:

June 2013

Completion Date:

December 2018

Related Keywords:

  • Liver Failure
  • Liver Failure

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