Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 16 of 31 for:    " February 16, 2011":" March 18, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention
HIV Infection
AIDS
Cirrhosis
Procedure: Hematopoietic stem cell transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by National Center for Global Health and Medicine, Japan:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309594

Locations
Japan
National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan, 1628655
Sponsors and Collaborators
National Center for Global Health and Medicine, Japan
Ministry of Health, Labour and Welfare, Japan
Investigators
Principal Investigator: Shinichi Oka, MD PhD National Center for Global Health and Medicine
  More Information

No publications provided

Responsible Party: National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier: NCT01309594     History of Changes
Other Study ID Numbers: FWA00005823-AMBi2011, UMIN000005174
Study First Received: March 3, 2011
Last Updated: September 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Cirrhosis
Digestive System Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014