Liver cirrhosis
Conditions
Interventions
Surgical collection of subcutaneous adipose tissue for manufacturing specified cell products and blood sampling for various laboratory tests. A total of 2 intravenous infusions of up to 3 x 10^7 cells
Sponsors
Ohnishi Shunsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female patients who are at least 18 years old and less than or equal to 70 years old at the time of obtaining consent (2) Patients with cirrhosis caused by hepatitis B virus, hepatitis C virus, or MAFLD (3) Patients with cirrhosis and Child-Pugh score 7 to 9 (4) Patients with an ECOG Performance Status of 2 or less (5) Patients who have been fully informed about their participation in this study and who have given written consent of their own free will based on sufficient understanding.
Exclusion criteria
Exclusion criteria: (1) Patients with malignant neoplasms or with a history of malignancy within 5 years (2) Patients with a history of hepatocellular carcinoma (3) Patients with a history of venous thrombosis or pulmonary embolism (4) Patients with esophageal or gastric varices with risk of bleeding observed during upper gastrointestinal endoscopy within the past 1 year (5) Patients with severe cardiac, renal, or respiratory complications. (6) Patients with serum creatinine level of 2 mg/dL or higher or T-Bil of 5.0 mg/dL or higher (7) Patients with hyperlactatemia (8) Patients with hypermagnesemia or hypothyroidism (9) Patients with a history of hypersensitivity to any component of donated albumin (10) Patients with a history of hypersensitivity to dimethyl sulfoxide (11) Patients with a history of hypersensitivity to hydroxyethyl starch (12) Patients with a history of hypersensitivity to gentamicin, other aminoglycoside antibiotics, or bacitracin (13) Patients or blood relatives with hearing loss or other hearing impairment due to aminoglycoside antibiotics (14) Patients with a history of hypersensitivity to xylocaine containing epinephrine (15) Patients with a history of hypersensitivity to cephem antibiotics (16) Patients with a history of hypersensitivity to hydrocortisone preparations or any of their components (17) Patients with a history of hypersensitivity to chlorpheniramine preparations or any of their components (18) Patients infected with parvovirus B19, HTLV-1, or HIV (19) Patients with drug abuse or alcoholism (20) Patients underwent organ transplantation or cell therapy (21) Patients who are pregnant or, in the case of women of childbearing potential, have a positive pregnancy test (22) Other patients deemed inappropriate as research subjects by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Countries
Japan
Contacts
Public ContactRishu Takimoto
LSI Sapporo clinic
Outcome results
None listed