HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation (HIV-ABMi)

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Information provided by (Responsible Party):

National Center for Global Health and Medicine, Japan

ClinicalTrials.gov Identifier:

NCT01309594

First received: March 3, 2011

Last updated: August 31, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2011

Last Updated Date

August 31, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Post-transplantation prognosis for cirrhosis [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01309594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of the treatment efficacy [ Time Frame: After 24 weeks up to 48 weeks ] [ Designated as safety issue: Yes ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

An interventional 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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infection
AIDS
Cirrhosis

Intervention ^ICMJE

Procedure: Autologous bone marrow cell infusion therapy (ABMi)

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

Other Name: Hematopoietic stem cell transplantation

Study Arm (s)

Experimental: 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

Intervention: Procedure: Autologous bone marrow cell infusion therapy (ABMi)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01309594

Other Study ID Numbers ^ICMJE

FWA00005823-AMBi2011, UMIN000005174

Has Data Monitoring Committee

Yes

Responsible Party

National Center for Global Health and Medicine, Japan

Study Sponsor ^ICMJE

National Center for Global Health and Medicine, Japan

Collaborators ^ICMJE

Ministry of Health, Labour and Welfare, Japan

Investigators ^ICMJE

Principal Investigator:

Shinichi Oka, MD PhD

National Center for Global Health and Medicine

Information Provided By

National Center for Global Health and Medicine, Japan

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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