Liver Regeneration
Conditions
Keywords
Confirmation, safety
Brief summary
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.
Interventions
PROCEDUREAutologous BMSCs
Cultured autologous bone marrow-derived mesenchymal stem cells
Sponsors
Yamaguchi University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Patients must provide informed consent for study participation.
Exclusion criteria
* Patients with a current history of malignant neoplasm. * Patients with gastroesophageal varices at risk of rupture. * Patients with renal insufficiency and a serum creatinine ≥2 mg/dL. * Patients with a hemoglobin \<8 g/dL, a platelet count \<50,000/μL, or a prothrombin time \<40%. * Patients with a performance status of 3 or 4. * Patients who refuse to consent to allogeneic blood transfusion. * Women who are pregnant. * Patients whom their attending physician deems are not suitable candidates for general anesthesia. * Patients with a current or previous severe allergic reaction to a contrast agent, beef, cow milk, and anesthesia. * Any patient deemed unsuitable for study inclusion by their attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events | up to 24 weeks the infusion |
Secondary
| Measure | Time frame |
|---|---|
| Child-Pugh score | up to 24 weeks the infusion |
| Serum albumin levels | up to 24 weeks the infusion |
| Serum fibrosis markers | 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 |
Countries
Japan
Contacts
Primary ContactTaro Takami, MD, PhD
Outcome results
None listed