UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005174 |
|---|---|
| Receipt number | R000006141 |
| Scientific Title | A safety and efficacy study of autologous bone marrow cell transplantation for HIV positive patients with cirrhosis |
| Date of disclosure of the study information | 2011/03/02 |
| Last modified on | 2017/05/02 20:49:27 |
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Basic information
Public title
A safety and efficacy study of autologous bone marrow cell transplantation for HIV positive patients with cirrhosis
Acronym
ABMi liver regeneration project
Scientific Title
A safety and efficacy study of autologous bone marrow cell transplantation for HIV positive patients with cirrhosis
Scientific Title:Acronym
ABMi liver regeneration project
Region
| Japan |
Condition
Condition
HIV infection, AIDS, Cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze and evaluate if autologous bone marrow transplantation can safely restore liver functions for HIV infected patients who have cirrhosis.
Basic objectives2
Others
Basic objectives -Others
Investigate how long the efficacy of the treatment will last.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are treatment safety and efficacy at the point of 24 weeks after the transplantation:
For Child-Pugh Score, -2 reduction or more as "improvement", change range within 1 as "no change", +2 increase or more as "worsening", respectively from the score before the transplantation. Also evaluate statistical significance between pre-transplantation and 24 weeks after.
For serum albumin and fibrosis markers, 10% changes before and after as "improvement" or "worsening". Evaluate statistical significance of albumin and Transient Elastography between the pre-transplantation and the 24 weeks after.
For image evaluation, three degrees of ascites [none, mild, severe] as in Child-Pugh Score with "improvement" as one or more degree improvement.
For self-reporting subjective symptoms, compare bottom-line scores of each sub-categorical scale in SF health score card.
Because cirrhosis is a progressive condition, treatment efficacy is defined by "improvement" and "no change" from the above.
Key secondary outcomes
The key secondary outcomes is the duration of the treatment effectiveness.
Using the same evaluation modules as of the primary outcomes, investigate and assess the chronological effectivity after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Autologous bone marrow transplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine and:
1) between 20 and 70 of age
2) have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B
3) able to consent and willing to participate in the study
4) under good control for HIV
Key exclusion criteria
Cases applicable to ANY condition of the following:
1) Hepatocellular carcinoma (HCC), except for cases having been treated completely without history of recurrence
2) Malignant tumor other than HCC
3) Alcoholic liver disease (ALD)
4) Hemoglobin under 8g/dL or Platelets under 20/ml at the registration
5) Esophageal or gastric varices with a risk of bursting, except for cases only with cured history of such conditions
6) Cases that cannot obtain the informed consent to autologous blood transfusion
7) Pregnancy
8) Renal dysfunction with 2mg/dL or higher serum creatinine
9) Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations)
10) not fit for general anesthesia
11) other conditions that doctor considered not suitable for the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo JAPAN
TEL
03-5273-5193
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihisa Tsukada |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo JAPAN
TEL
03-3202-7181(5369)
Homepage URL
ktsukada@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01309594
Org. issuing International ID_1
NIH
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立国際医療研究センター病院（東京都）、山口大学医学部附属病院（山口県）、奈良県立医科大学附属病院（奈良県）、国立病院機構岡山医療センター病院（岡山県）、東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 02 | Day |
Last modified on
| 2017 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006141
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