Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

NCT02327832 | Unknown Phase 1

• 1 other identifier: ICHINAI-BMSC1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Regeneration

Keywords

Confirmation; safety

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events

  up to 24 weeks the infusion

Secondary Outcomes (5)

• 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

Study Arms (1)

Autologous BMSCs

EXPERIMENTAL

Infusion of cultured autologous bone marrow derived mesenchymal stem cells

Procedure: Autologous BMSCs; Drug: bone marrow-derived mesenchymal stem cells

Interventions

Autologous BMSCs PROCEDURE

Cultured autologous bone marrow-derived mesenchymal stem cells

Also known as: BMSC

Autologous BMSCs

bone marrow-derived mesenchymal stem cells DRUG

Autologous BMSCs

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are still deemed unsuitable as a candidate for general anesthesia.
• Patients must provide informed consent for study participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yamaguchi University Hospital: lead

Study Sites (1)

Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine

Ube, Yamaguchi, Yamaguchi, 7558505, Japan

RECRUITING

Study Officials

• Isao Sakaida, MD, PhD

  Yamaguchi University Hospital

  STUDY CHAIR

Central Study Contacts

Taro Takami, MD, PhD

CONTACT

+81836222241; naika1_w@yamaguchi-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: December 30, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

JP (1)