Back to resultsHIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation (HIV-ABMi)
Primary Purpose
HIV Infection, AIDS, Cirrhosis
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Hematopoietic stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
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
Sites / Locations
- National Center for Global Health and Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hematopoietic stem cell transplantation
Arm Description
Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01309594
First Posted
March 3, 2011
Last Updated
September 24, 2014
Sponsor
National Center for Global Health and Medicine, Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
1. Study Identification
Unique Protocol Identification Number
NCT01309594
Brief Title
HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation
Acronym
HIV-ABMi
Official Title
A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Global Health and Medicine, Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, AIDS, Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hematopoietic stem cell transplantation
Arm Type
Experimental
Arm Description
Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic stem cell transplantation
Other Intervention Name(s)
Autologous bone marrow cell infusion therapy (ABMi)
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-transplantation prognosis for cirrhosis
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Duration of the treatment efficacy
Description
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.
Time Frame
After 24 weeks up to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichi Oka, MD PhD
Organizational Affiliation
National Center for Global Health and Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Global Health and Medicine
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
1628655
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation
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