HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation

A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis

An international investigation to evaluate if, and if so how long, autologous bone marrow hematopoietic stem cell transplantation can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.

An international investigation to evaluate if, and if so how long, autologous bone marrow (ABM) hematopoietic stem cell transplantation (HSCT) can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.

Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:

• have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B
• able to consent and willing to participate in the study
• under good control for HIV infection

Exclusion Criteria: Cases applicable to ANY condition of the following:

• Hepatocellular carcinoma (HCC), except for cases having been completely treated without history of recurrence
• Malignant tumors other than HCC
• Alcoholic liver disease (ALD)
• Hemoglobin under 8g/dL or Platelets under 20/ml at the registration
• Esophageal or gastric varices with a risk of bursting, except for cases with only cured history of such conditions
• Cases that cannot obtain the informed consent to autologous blood transfusion
• Pregnancy
• Renal dysfunction with 2mg/dL or higher serum creatinine
• Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations)
• Cases not fit for general anesthesia
• Other conditions considered not suitable for the study by doctors