Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Decompensated Liver Cirrhotic Patient.
- Conditions
- decompensated liver cirrhosis
- Registration Number
- JPRN-UMIN000016686
- Lead Sponsor
- Yamaguchi University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
(1) Patients with a current history of malignant neoplasm. (2) Patients with gastroesophageal varices at risk of rupture. (3) Patients with renal insufficiency and a serum creatinine greater than or equal to 2 mg/dL. (4) Patients with a hemoglobin <8 g/dL, a platelet count <50,000/uL, or a prothrombin time <40%. (5) Patients with a performance status of 3 or 4. (6) Patients who refuse to consent to allogeneic blood transfusion. (8) Women who are pregnant. (9) Patients with a current or previous severe allergic reaction to anesthesia. (10) Patients with a current or previous severe allergic reaction to a contrast agent. (11) Patients with a current or previous severe allergic reaction to beef, cow milk. (12) Patients who had an experience with other cell therapy or other clinical study of cell therapy. (13) Any patient deemed unsuitable for study inclusion by their attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of adverse events
- Secondary Outcome Measures
Name Time Method (1) Child-Pugh score (2) Serum albumin levels (3) Serum fibrosis markers (4) Improvement or disappearance of lower extremity edema (5) Subjective symptom scores (SF-36)