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: September 24, 2014
Last verified: September 2014

March 3, 2011
September 24, 2014
March 2011
March 2016   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01309594 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • AIDS
  • Cirrhosis
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
Other Name: Autologous bone marrow cell infusion therapy (ABMi)
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: Hematopoietic stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01309594
FWA00005823-AMBi2011, UMIN000005174
Yes
National Center for Global Health and Medicine, Japan
National Center for Global Health and Medicine, Japan
Ministry of Health, Labour and Welfare, Japan
Principal Investigator: Shinichi Oka, MD PhD National Center for Global Health and Medicine
National Center for Global Health and Medicine, Japan
September 2014

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