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

Not Applicable

• Conditions: HIV Infection; AIDS; Cirrhosis
• Interventions: Procedure: Hematopoietic stem cell transplantation

• Registration Number: NCT01309594
• Lead Sponsor: National Center for Global Health and Medicine, Japan

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hematopoietic stem cell transplantation	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

Primary Outcome Measures

Name	Time	Method
Post-transplantation prognosis for cirrhosis	24 weeks	Evaluate statistical significance between pre-transplantation and 24 weeks after in: * Child-Pugh score; * albumin; * serum fibrosis markers; * Transient Elastography (TM); * ascites imagery; * SF-36v2(TM) Health Survey.; Because advanced liver cirrhosis is a progressive condition itself, treatment efficacy is defined by "improvement" and "no change" in the indicators listed.

Secondary Outcome Measures

Name	Time	Method
Duration of the treatment efficacy	After 24 weeks up to 48 weeks	Using the same evaluation modules as of the primary outcomes, investigate and assess the autologous bone marrow transplantation effectivity chronologically after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy.

Trial Locations

Locations (1)

National Center for Global Health and Medicine; 🇯🇵 Shinjuku, Tokyo, Japan