Clinical trial NCT02327832: Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Liver Regeneration
Keywords: Confirmation
safety
Lead sponsor: Yamaguchi University Hospital
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of adverse events
timeFrame: up to 24 weeks the infusion
Secondary outcomes:
measure: Child-Pugh score
timeFrame: up to 24 weeks the infusion
measure: Serum albumin levels
timeFrame: up to 24 weeks the infusion
measure: Serum fibrosis markers
timeFrame: up to 24 weeks the infusion
measure: Improvement or disappearance of lower extremity edema
timeFrame: up to 24 weeks the infusion
measure: Subjective symptom scores (SF-36)
timeFrame: up to 24 weeks the infusion
Other outcomes:
Locations:
city: Ube, Yamaguchi
country: Japan
facility: Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine
state: Yamaguchi
Study officials:
affiliation: Yamaguchi University Hospital
name: Isao Sakaida, MD, PhD
role: STUDY_CHAIR
References: