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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01309594

Acronym

HIV-ABMi

Enrollment

Registered

2011-03-07

Start date

2011-03-31

Completion date

2016-03-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, Cirrhosis, HIV Infection

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.

Interventions

PROCEDUREHematopoietic 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026