Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

Study Overview
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Brief Summary
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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.

Official Title
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Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Compensated Liver Cirrhotic Patient

Conditions
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Liver Regeneration

Intervention / Treatment
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* Procedure: Autologous BMSCs
* Drug: bone marrow-derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous BMSCs<br>Infusion of cultured autologous bone marrow derived mesenchymal stem cells | Procedure: Autologous BMSCs<br>* Cultured autologous bone marrow-derived mesenchymal stem cells<br>* Other names: BMSC;Drug: bone marrow-derived mesenchymal stem cells<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events |  | up to 24 weeks the infusion | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Confirmation, safety