UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016686 |
|---|---|
| Receipt number | R000019363 |
| Scientific Title | Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Decompensated Liver Cirrhotic Patient. |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2015/03/02 19:32:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Decompensated Liver Cirrhotic Patient.
Acronym
Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs.
Scientific Title
Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Decompensated Liver Cirrhotic Patient.
Scientific Title:Acronym
Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs.
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured
Autologous Bone Marrow-derived Mesenchymal Stem Cells for Decompensated Liver Cirrhotic Patient
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence of adverse events
Key secondary outcomes
(1) Child-Pugh score
(2) Serum albumin levels
(3) Serum fibrosis markers
(4) Improvement or disappearance of lower extremity edema
(5) Subjective symptom scores (SF-36)
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
Infusion of cultured autologous bone marrow derived mesenchymal stem cells.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score greater than or equal to 7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected.
(2) age 20 to 75 years.
(3) serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia.
(4) Patients must provide informed consent for study participation.
Key exclusion criteria
(1) Patients with a current history of malignant neoplasm.
(2) Patients with gastroesophageal varices at risk of rupture.
(3) Patients with renal insufficiency and a serum creatinine greater than or equal to 2 mg/dL.
(4) Patients with a hemoglobin <8 g/dL, a platelet count <50,000/uL, or a prothrombin time <40%.
(5) Patients with a performance status of 3 or 4.
(6) Patients who refuse to consent to allogeneic blood transfusion.
(8) Women who are pregnant.
(9) Patients with a current or previous severe allergic reaction to anesthesia.
(10) Patients with a current or previous severe allergic reaction to a contrast agent.
(11) Patients with a current or previous severe allergic reaction to beef, cow milk.
(12) Patients who had an experience with other cell therapy or other clinical study of cell therapy.
(13) Any patient deemed unsuitable for study inclusion by their attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Sakaida |
Organization
Yamaguchi University Hospital
Division name
Department of Gastroenterology and 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 | Taro Takami |
Organization
Yamaguchi University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2241
Homepage URL
naika1_w@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
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
山口大学医学部附属病院（Yamaguchi University Hospital）
Other administrative information
Date of disclosure of the study information
| 2015 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 02 | 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
| 2015 | Year | 03 | Month | 02 | Day |
Last modified on
| 2015 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019363
