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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infection, AIDS, Cirrhosis

Intervention / Treatment
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* Procedure: Hematopoietic stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hematopoietic stem cell transplantation<br>Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients | Procedure: Hematopoietic stem cell transplantation<br>* 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<br>* Other names: Autologous bone marrow cell infusion therapy (ABMi);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-transplantation prognosis for cirrhosis | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the treatment efficacy | 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. | After 24 weeks up to 48 weeks |