drugset / Trial / NCT05727722
Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults
Phase 1
Recruiting
10 enrolled
RenJi Hospital
Shanghai Institute of Biochemistry and Cell Biology · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease. We previously generated proliferating human hepatocytes (ProliHH) through dedifferentiation of PHH and engineered them into encapsulated liver organoids (eLO), providing an unlimited cell source for hepatocyte transplantation.
Timeline
- Start
- 2024-03-01
- Primary completion
- 2025-12-31
- Completion
- 2026-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | micro-encapsulated hepatocytes | Unknown | 1.5e+08 cells | Other |
| Subject | micro-encapsulated hepatocytes | Unknown | 5e+08 cells | Other |
| Subject | micro-encapsulated hepatocytes | Unknown | 1.5e+09 cells | Other |
| Subject | micro-encapsulated hepatocytes | Unknown | 4.5e+09 cells | Other |