HIV InfectionHIV-ABMiNCT01309594
HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation
A study testing Hematopoietic stem cell transplantation in people with HIV Infection and AIDS, run by National Center for Global Health and Medicine, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- HIV Infection, AIDS, Cirrhosis
- What is being tested?
- Hematopoietic stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Center for Global Health and Medicine
Shinjuku, Tokyo, 1628655
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infection, AIDS, Cirrhosis
- Being tested
- Hematopoietic stem cell transplantation
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic stem cell transplantationProcedure or surgery
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (1)
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.
Measured: After 24 weeks up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Global Health and Medicine, Japan
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor
- Investigators
- Shinichi Oka, MD PhD, Principal investigator, National Center for Global Health and Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309594
- Sponsor's protocol ID
- FWA00005823-AMBi2011
- Other IDs
- UMIN000005174
- Acronym
- HIV-ABMi
- Status last verified
- Sep 2014
- First submitted
- 3 Mar 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01309594
- Acronym / sponsor ID
- HIV-ABMi / FWA00005823-AMBi2011
- Conditions
- HIV Infection, AIDS, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Center for Global Health and Medicine, JapanOther government
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Mar 2011
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematopoietic stem cell transplantation | Experimental | Procedure: Hematopoietic stem cell transplantationExtraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematopoietic stem cell transplantationAlso: 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 | Procedure or surgery | Hematopoietic stem cell transplantation |
Primary outcome
Post-transplantation prognosis for cirrhosis
Time frame: 24 weeks
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.
1 secondary outcome
Duration of the treatment efficacy
Time frame: After 24 weeks up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shinichi Oka, MD PhD principal investigator
National Center for Global Health and Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematopoietic stem cell transplantation in people with HIV Infection and AIDS, run by National Center for Global Health and Medicine, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-transplantation prognosis for cirrhosis (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.