UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011651 |
|---|---|
| Receipt number | R000013624 |
| Scientific Title | Evaluation for the effectiveness and safety for Autologous Bone Marrow Cell infusion (ABMi) therapy for HCV infected liver cirrhosis patient. |
| Date of disclosure of the study information | 2013/09/14 |
| Last modified on | 2018/12/12 13:23:17 |
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Basic information
Public title
Evaluation for the effectiveness and safety for Autologous Bone Marrow Cell infusion (ABMi) therapy for HCV infected liver cirrhosis patient.
Acronym
ABMi therapy for liver cirrhosis (HCV)
Scientific Title
Evaluation for the effectiveness and safety for Autologous Bone Marrow Cell infusion (ABMi) therapy for HCV infected liver cirrhosis patient.
Scientific Title:Acronym
ABMi therapy for liver cirrhosis (HCV)
Region
| Japan |
Condition
Condition
HCV infection, Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of Autologous Bone Marrow Cell infusion therapy for HCV related liver cirrhosis patients compared with standard medical treatment (Child-Pugh Score)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of Child-Pugh score at 24 weeks after ABMi therapy and control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Autologous Bone Marrow Cell infusion
Interventions/Control_2
Standard medical treatment
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Liver cirrhosis related with HCV infection
(2) Liver cirrhosis with Child-Pugh Score (over 7) in Child-Pugh B persist for 90 more days, refractory to standard medical treatment
(3) >=20 years old and <=75 years old
(4) Patient must have signed the consent form
Key exclusion criteria
(1) Liver cirrhosis induced by other factor without HCV infection and unknown reasons
(2) have a malignant neoplasm, or a history of malignant neoplasm (Including HCC)
(3) have risk of Esophageal or/and gastric varices
(4) Renal dysfunction with 2mg/dL or higher serum creatinine
(5) hemoglobin under 8g/dL or Platelets under 50/mL or Prothrombin activity under 40%
(6) Total bilirubin 3.0mg/dL or more
(7) Performance Status 3 or 4
(8) Cases that cannot obtain the informed consent to autologous blood transfusion
(9) undeniable possibility for HBV infection, HIV infection, ATL infection, human parvovirus B19 infection
(10) Pregnancy
(11) not fit for general anesthesia
(12) have a severe allergic reaction to contrast dye or a history of a severe allergic reaction to contrast dye
(13) other conditions that doctor considered not suitable for the study
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Sakaida |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2241
sakaida@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Terai |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2241
Homepage URL
terais@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013624
