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

NCT ID: NCT01309594

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Detailed 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.

Conditions

HIV Infection; AIDS; Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hematopoietic stem cell transplantation

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

Group Type: EXPERIMENTAL

Hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

Harvest and apheresis of bone marrow cells from HIV infected patients with cirrhosis under general anesthesia, using bone marrow collection system and transplanting the patients' hematopoietic stem cells back to the patients

Interventions

Hematopoietic stem cell transplantation

Harvest and apheresis of bone marrow cells from HIV infected patients with cirrhosis under general anesthesia, using bone marrow collection system and transplanting the patients' hematopoietic stem cells back to the patients

Intervention Type: PROCEDURE

Other Intervention Names

Autologous bone marrow cell infusion therapy (ABMi)

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

National Center for Global Health and Medicine, Japan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shinichi Oka, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Global Health and Medicine

Locations

National Center for Global Health and Medicine

Shinjuku, Tokyo, Japan

Countries

Japan

Other Identifiers

UMIN000005174

Identifier Type: OTHER

Identifier Source: secondary_id

FWA00005823-AMBi2011

Identifier Type: -

Identifier Source: org_study_id