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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016686

Enrollment

Registered

2015-03-02

Start date

2015-03-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

decompensated liver cirrhosis

Interventions

Infusion of cultured autologous bone marrow derived mesenchymal stem cells.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score greater than or equal to 7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. (2) age 20 to 75 years. (3) 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. (4) Patients must provide informed consent for study participation.

Exclusion criteria

Exclusion criteria: (1) Patients with a current history of malignant neoplasm. (2) Patients with gastroesophageal varices at risk of rupture. (3) Patients with renal insufficiency and a serum creatinine greater than or equal to 2 mg/dL. (4) Patients with a hemoglobin <8 g/dL, a platelet count <50,000/uL, or a prothrombin time <40%. (5) Patients with a performance status of 3 or 4. (6) Patients who refuse to consent to allogeneic blood transfusion. (8) Women who are pregnant. (9) Patients with a current or previous severe allergic reaction to anesthesia. (10) Patients with a current or previous severe allergic reaction to a contrast agent. (11) Patients with a current or previous severe allergic reaction to beef, cow milk. (12) Patients who had an experience with other cell therapy or other clinical study of cell therapy. (13) Any patient deemed unsuitable for study inclusion by their attending physician.

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events	—

Secondary

Measure	Time frame
(1) Child-Pugh score (2) Serum albumin levels (3) Serum fibrosis markers (4) Improvement or disappearance of lower extremity edema (5) Subjective symptom scores (SF-36)	—

Countries

Japan

Contacts

Public ContactTaro Takami

Yamaguchi University Hospital Department of Gastroenterology and Hepatology

naika1_w@yamaguchi-u.ac.jp0836-22-2241

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026