Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

Phase 1

• Conditions: Liver Regeneration
• Interventions: Procedure: Autologous BMSCs; Drug: bone marrow-derived mesenchymal stem cells

• Registration Number: NCT02327832
• Lead Sponsor: Yamaguchi University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous BMSCs	Autologous BMSCs	Infusion of cultured autologous bone marrow derived mesenchymal stem cells
Autologous BMSCs	bone marrow-derived mesenchymal stem cells	Infusion of cultured autologous bone marrow derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events	up to 24 weeks the infusion

Secondary Outcome Measures

Name	Time	Method
Subjective symptom scores (SF-36)	up to 24 weeks the infusion
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

Trial Locations

Locations (1)

Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine; 🇯🇵 Ube, Yamaguchi, Yamaguchi, Japan