Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Regeneration
• Intervention / Treatment: Procedure: Autologous BMSCs; Drug: bone marrow-derived mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Taro Takami, MD, PhD; Phone Number: +81836222241; Email: naika1_w@yamaguchi-u.ac.jp

Study Locations

• Japan
  • Yamaguchi
    • Ube, Yamaguchi, Yamaguchi, Japan, 7558505
      • Recruiting
      • Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine
      • Contact: Taro Takami, MD, PhD; Phone Number: +81836222241; Email: t-takami@yamaguchi-u.ac.jp
      • Principal Investigator: Isao Sakaida, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous BMSCs; Infusion of cultured autologous bone marrow derived mesenchymal stem cells	Procedure: Autologous BMSCs; Cultured autologous bone marrow-derived mesenchymal stem cells; Other Names: BMSC; Drug: bone marrow-derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Yamaguchi University Hospital
• Investigators: Study Chair: Isao Sakaida, MD, PhD, Yamaguchi University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 24, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: safety; Confirmation
• Other Study ID Numbers: ICHINAI-BMSC1