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

HIV Infection Clinical Trial

— HIV-ABMi  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01309594
• Other study ID #: FWA00005823-AMBi2011
• Secondary ID: UMIN000005174
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 3, 2011
• Last updated: September 24, 2014
• Start date: March 2011
• Est. completion date: March 2016

Study information

• Verified date: September 2014
• Source: National Center for Global Health and Medicine, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• Cirrhosis
• HIV Infection
• Liver Cirrhosis

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Japan	National Center for Global Health and Medicine	Shinjuku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Global Health and Medicine, Japan	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes