UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028965 |
|---|---|
| Receipt number | R000033137 |
| Scientific Title | Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2025/03/10 17:54:17 |
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Basic information
Public title
Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis
Acronym
Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosis
Scientific Title
Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis
Scientific Title:Acronym
Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosis
Region
| Japan |
Condition
Condition
Decompensated liver cirrhosis (Hepatitis C virus-related)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to examine the safety and efficacy of transhepatic administration of autologous G-CSF mobilized peripheral blood CD34 positive cells compared with standard medical therapy in patients with hepatitis C virus-related liver cirrhosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Non-exacerbation rate of Child-Pugh score at 24 weeks after treatment
Key secondary outcomes
1) Child-Pugh Score
2) MELD Score
3) Ascites by abdominal ultrasonography and abdominal CT
4) Serum albumin, total protein, total bilirubin value and PT-INR
5) Serum hyaluronic acid and type-IV collagen
6) QOL evaluation by SF-36v2
7) Portal blood flow and velocity by abdominal ultrasonography
8) Death due to liver cirrhosis and all deaths
9) Onset of hepatocellular carcinoma
10) Performance and bugs of magnetic cell separation device
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
G-CSF administration(5 days), Apheresis, Transhepatic arterial administration of CD34 positive cells
Interventions/Control_2
Standard medical therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with hepatitis C virus-related liver cirrhosis
2) Patients eligible for this study include those with hepatitis C virus-related decompensated liver cirrhosis with a Child-Pugh Score greater than or equal to 7 points in whom further improvement with current standard medical treatment is not expected at two points more than 90 days apart
3) Patients who aged 20 to 80 years
4) Patient who can give written informed consent themselves
Key exclusion criteria
1) Patients with HCV-related liver cirrhosis or cryptogenic liver cirrhosis
2) Patients who are positive for HBs-Ag, HIV-Ab, HTLV1-Ab, serological test for syphilis and HBc-Ab (CLIA method >10.00 S/CO)
3) Patients with alcoholic drinkers, Patients with a Child-Pugh Score less than or equal to 6 points in whom further improvement with abstinence for more than 6 months.
4) Patients complicated of malignant tumor or patients with a history of malignant tumor within 5 years (However, for patients with a history of intraepithelial carcinoma [e.g., colon mucosal cancer] and hepatocellular carcinoma, which are negative for AFP and PIVKA-II, is not excluded)
5) Total bilirubin> 5.0 mg/dL
6) Prothrombin time less than 30%
7) Serum creatinine> 2.0 mg/dL
8) Hemoglobin less than 8 g/dL
9) Platelet less than 20,000 / uL
10) Patients who have splenomegaly with longitudinal spleen diameter more than 15 cm by abdominal CT
11) Patients who have gastrointestinal bleeding or patients who may cause bleeding in the gastrointestinal tract
12) Patients with portal vein thrombosis
13) Patients currently suffering from or having a history of interstitial pneumonia
14) Patients with hematological disease (leukemia, myeloproliferative disease, myelodysplastic syndrome or sickle cell anemia)
15) Patients with autoimmune disease
16) Patients with less than 3 months since last episode of unstable angina, myocardial/cerebral infarction, Patients with less than 3 months since coronary artery/carotid artery/intracranial artery stenting
17) Patients with proliferative diabetic retinopathy
18) Patients with a history of severe allergic reactions or side effects to G-CSF, apheresis, or a contrast agents
19) Pregnant women, lactating women, patients who may be pregnant, female patients planning pregnancy during the study period
20) Any other reason that the Clinical Supervision or Clinical Researchers may have for considering a case unsuitable for the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Torimura |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7561
tori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Nakamura |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7561
Homepage URL
ntoru@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan Kamakura General Hospital Certified Committee for Regenerative Medicine
Address
1370-1, Okamoto, Kamakura-shi, Kanagawa, Japan
Tel
03-3263-4801
rm_committee2@shonankamakura.or.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
関西医科大学附属病院(大阪府)
兵庫医科大学病院（兵庫県）
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTb070190052
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTb070190052
Number of participants that the trial has enrolled
14
Results
The primary endpoint, the non-progression rate of Child-Pugh (CP) score at 24 weeks at 24 weeks after enrollment, was 90% in the cell transplant group and 100% in the standard treatment group, with no significant differences between groups.
Results date posted
| 2024 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 04 | Month | 25 | Day |
Baseline Characteristics
The CD34+ cell group included 7 men and 3 women with a mean age of 62.8 +- 9.1 years, while the SOC group included 1 man and 3 women with a mean age of 70.8 +- 7.8 years. The CP score, which reflects the patients liver functional reserve, was 8.0 +- 1.2 points in the CD34+ cell group (9 patients in CP-B and 1 patient in CP-C) and 8.0 +- 1.4 points in the SOC group (3 patients in CP-B and 1 patient in CP-C). With regard to HCV elimination prior to enrollment, there were 2 non-SVR (HCV-RNA positive) patients and 8 SVR (HCV-RNA negative) patients in the CD34+ cell group, while there were 2 non-SVR patients and 2 SVR patients in the SOC group.
Participant flow
After written consent was obtained from 19 patients, a pre-enrollment examination was conducted, and 14 patients were enrolled after excluding those who were ineligible patients. Fourteen patients (10 in the CD34+ cell group and 4 in the SOC group) started treatment, all of whom completed the study period up to 52 weeks after enrollment.
Adverse events
Three serious adverse events occurred in the cell transplant group and one in the standard treatment group. There were no deaths due to cirrhosis, no all-cause mortality, and no occurrence of hepatocellular carcinoma in all patients.
Outcome measures
Primary endpoint: 1) Non-exacerbation rate of Child-Pugh score at 24 weeks after treatment, 2)Safety for protocol treatment (severity, severity and frequency of adverse events)
Secondary endpoint: 1) Child-Pugh Score, 2) MELD Score, 3) Ascites by abdominal ultrasonography and abdominal CT, 4) Serum albumin, total protein, total bilirubin value and PT-INR, 5) Serum hyaluronic acid and type-IV collagen, 6) QOL evaluation by SF-36v2, 7) Portal blood flow and velocity by abdominal ultrasonography, 8) Death due to liver cirrhosis and all deaths, 9) Onset of hepatocellular carcinoma, 10) Performance and bugs of magnetic cell separation device
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033137
