Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

Liver Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02327832
• Other study ID #: ICHINAI-BMSC1
• Status: Recruiting
• Phase: Phase 1
• First received: December 24, 2014
• Last updated: December 29, 2014
• Start date: December 2014

Study information

• Verified date: December 2014
• Source: Yamaguchi University Hospital
• Contact: Taro Takami, MD, PhD
• Phone: +81836222241
• Email: naika1_w[@]yamaguchi-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Regeneration

Intervention

Procedure:
• Autologous BMSCs
Cultured autologous bone marrow-derived mesenchymal stem cells

Drug:
• bone marrow-derived mesenchymal stem cells

Locations

Country	Name	City	State
Japan	Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine	Ube, Yamaguchi	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Yamaguchi University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events		up to 24 weeks the infusion	Yes
Secondary	Child-Pugh score		up to 24 weeks the infusion	No
Secondary	Serum albumin levels		up to 24 weeks the infusion	No
Secondary	Serum fibrosis markers		up to 24 weeks the infusion	No
Secondary	Improvement or disappearance of lower extremity edema		up to 24 weeks the infusion	No
Secondary	Subjective symptom scores (SF-36)		up to 24 weeks the infusion	No