Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis

JRCT ID: jRCTb060190035

Registered date:25/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: decompensated liver cirrhosis
• Date of first enrollment: 23/07/2019
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Hepatic arterial infusion of cultured autologous bone marrow-derived mesenchymal stem cells

Outcome(s)

• Primary Outcome: The incidence of adverse events with hepatic arterial infusion of cultured autologous bone marrow cells

Secondary Outcome

(1) Child-Pugh score
(2) Serum albumin levels
(3) Serum fibrosis markers
(4) Liver stiffness
(5) Portal blood flow

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude criteria

(1) Patients with a current history of malignant neoplasm with the exception of carcinoma in situ.
(2) Patients with gastroesophageal varices at risk of rupture.
(3) History of alcohol abuse within the last 6 months prior to acquiring a consent to study.
(4) Patients with total bilirubin of 5.0mg/dL or higher
(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.
(9) Patients for whom infection with syphilis, HIV, adult T-cell leukemia virus, parvovirus B19 cannot be ruled out
(10) Women who are pregnant.
(11) Patients for whom angiography cannot be carried out.
(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.
(16) Participated in a concurrent interventional study with the last intervention occurring within 6 months prior to acquiring a consent to study.
(17) Any patient deemed unsuitable for study inclusion by their attending physician.

Related Information

• Primary Sponsor: Taro Takami
• Source(s) of Monetary Support: SHIBUYA CORPORATION