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Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin was added after collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was prepared by adding culture medium, and this was inoculated into a culture flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous BMSCs | Experimental | Infusion of cultured autologous bone marrow derived mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous BMSCs | Procedure | Cultured autologous bone marrow-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events | up to 24 weeks the infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Child-Pugh score | up to 24 weeks the infusion | |
| Serum albumin levels | up to 24 weeks the infusion | |
| Serum fibrosis markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taro Takami, MD, PhD | Contact | +81836222241 | naika1_w@yamaguchi-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Isao Sakaida, MD, PhD | Yamaguchi University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine | Recruiting | Ube, Yamaguchi | Yamaguchi | 7558505 | Japan |
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| bone marrow-derived mesenchymal stem cells | Drug |
|
| up to 24 weeks the infusion |
| Improvement or disappearance of lower extremity edema | up to 24 weeks the infusion |
| Subjective symptom scores (SF-36) | up to 24 weeks the infusion |