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Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Sponsor: Dr Cipto Mangunkusumo General Hospital
Summary
This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.
Official title: A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
20 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2022-08-29
Completion Date
2026-12
Last Updated
2023-09-26
Healthy Volunteers
No
Conditions
Interventions
Autologous Natural Killer Cell Therapy
The therapy will be administered intravenously
Clinimacs Plus
The CliniMACS Plus device is an automated cell separation tool that uses MACS Technology. It incorporates a flexible system designed for isolating clinically labeled cells using MicroBeads.
Locations (1)
Cipto Mangunkusumo General Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia