UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035528 |
|---|---|
| Receipt number | R000040478 |
| Scientific Title | Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis |
| Date of disclosure of the study information | 2019/01/15 |
| Last modified on | 2022/07/16 10:00:02 |
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Basic information
Public title
Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis
Acronym
Study on the safety of liver regeneration therapy with hepatic arterial infusion of cultured autologous bone marrow cells
Scientific Title
Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis
Scientific Title:Acronym
Study on the safety of liver regeneration therapy with hepatic arterial infusion of cultured autologous bone marrow cells
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of invasive liver regeneration therapy with hepatic artery infusion of cultured autologous bone marrow cells in patients with decompensated cirrhosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence of adverse events with hepatic arterial infusion of cultured autologous bone marrow cells
Key secondary outcomes
(1) Child-Pugh score
(2) Serum albumin levels
(3) Serum fibrosis markers
(4) Liver stiffness
(5) Portal blood flow
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
Hepatic arterial 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 with decompensated liver cirrhosis with a Child-Pugh score of 7 or higher (Child-Pugh B) at two points separated by at least 90 days, in whom further improvement is not expected with current medical treatment.
(2) Patients aged 20 to 75 years.
(3) Patients from whom written consent for participation in this clinical study was obtained.
Key exclusion criteria
(1) Patients with a current history of malignant neoplasm.
(2) Patients with gastroesophageal varices at risk of rupture.
(5) Patients with a hemoglobin <8 g/dL, a platelet count <50,000/uL, or a prothrombin time <40%.
(6) Patients with renal insufficiency and a serum creatinine greater than or equal to 2 mg/dL.
(7) Patients with a performance status of 3 or 4.
(8) Patients who refuse to consent to allogeneic blood transfusion.
(10) Women who are pregnant.
(12) Patients with a current or previous severe allergic reaction to anesthesia.
(13) Patients with a current or previous severe allergic reaction to a contrast agent.
(14) Patients with a current or previous severe allergic reaction to beef, cow milk.
(15) Patients who had an experience with other cell therapy or other clinical study of cell therapy.
(17) Any patient deemed unsuitable for study inclusion by their attending physician.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Takami |
Organization
Yamaguchi University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan
TEL
+81836222241
t-takami@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Takami |
Organization
Yamaguchi University
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan
TEL
+81836222241
Homepage URL
t-takami@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi Pref and self funding
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital Certified Committee for Regenerative Medicine
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan
Tel
0836-22-2428
ysaisei@yamaguchi-u.ac.jp
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
| 2019 | Year | 01 | Month | 15 | 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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040478
