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

Phase 1
Conditions
decompensated liver cirrhosis
Registration Number
JPRN-UMIN000035528
Lead Sponsor
Yamaguchi University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
5
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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