Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosis

JRCT ID: jRCTb070190052

Registered date:17/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Decompensated liver cirrhosis (Hepatitis C virus-related)
• Date of first enrollment: 02/12/2017
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

[Randomized, Open-Label, Parallel Study]
We randomly assigned (2:1) patients to receive either the CD34 positive cell transplantation group or the standard medical therapy group. Randomisation was stratified based on the implementing medical institution (4 organizations) and Child-Pugh Score (B or C). The assignment was enforced at TRI data center.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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 (For patients who have received DAA treatment, take 2 points after 12 weeks have passed since the end of DAA treatment [or final medication if DAA treatment was stopped])
3) Patients who aged 20 to 80 years
4) Patient who can give written informed consent themselves

Exclude criteria

1) Patients with HCV-related liver cirrhosis or cryptogenic liver cirrhosis
2) Patients complicated of malignant tumor or patients with a history of malignant tumor within 5 years (However, patients with a history of intraepithelial carcinoma [e.g. colon mucosal cancer] are not excluded if there is no recurrence; patients with a history of hepatocellular carcinoma, which are negative for AFP and PIVKA-II, are not excluded if there is no recurrence; patients with a history of hepatocellular carcinoma, which are positive for AFP or PIVKA-II, are not excluded if there is no recurrence at two points more than 3 months apart.)
3) Patients who have gastrointestinal bleeding or patients who may cause bleeding in the gastrointestinal tract
4) Patients with portal vein thrombosis (However, patients who do not affect the condition, such as wall thrombosis localized in a part of the portal vein, are not excluded.)
5) Patients with a history of severe allergic reactions or side effects to G-CSF, apheresis, or a contrast agents
6) History of hypersensitivity or drug reaction to mouse-derived proteins.
7) History of hypersensitivity or drug reaction to iron or iron dextran.
8) Patients who have splenomegaly with longitudinal spleen diameter more than 15 cm by abdominal CT

Related Information

• Primary Sponsor: Nakamura Toru