Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

Yamaguchi University Hospital

Status and phase

Unknown

Phase 1

Conditions

Liver Regeneration

Treatments

Drug: bone marrow-derived mesenchymal stem cells

Procedure: Autologous BMSCs

Study type

Interventional

Funder types

Other

Identifiers

NCT02327832

ICHINAI-BMSC1

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.