HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation (HIV-ABMi)

National Center for Global Health and Medicine, Japan

Status: Unknown

Conditions: AIDS; Cirrhosis; HIV Infection

Treatments: Procedure: Hematopoietic stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01309594

FWA00005823-AMBi2011

UMIN000005174 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Hematopoietic stem cell transplantation

Experimental group

Description:

Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients

Treatment:

Procedure: Hematopoietic stem cell transplantation