NCT01309594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

5 years

First QC Date

March 3, 2011

Last Update Submit

September 24, 2014

Conditions

HIV InfectionAIDSCirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Duration of the treatment efficacy

    After 24 weeks up to 48 weeks

Study Arms (1)

Hematopoietic stem cell transplantation

EXPERIMENTAL

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

Interventions

Hematopoietic stem cell transplantationPROCEDURE

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

Also known as: Autologous bone marrow cell infusion therapy (ABMi)
Hematopoietic stem cell transplantation

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Global Health and Medicine

Shinjuku, Tokyo, 1628655, Japan

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeFibrosis

Interventions

Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Shinichi Oka, MD PhD

    National Center for Global Health and Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

JP(1)