iver NK cell therapy for preventing infection after liver transplant

Phase 1

• Conditions: Decompensated liver cirrhosis patients who will receive liver transplantation

• Registration Number: JPRN-jRCTa060190036
• Lead Sponsor: Ohdan Hideki

Brief Summary

Although 37 patients were planned to be enrolled in the study, 6 (31.5%) patients developed bacteremia at the time of 19 cases, and the study was terminated because it was difficult to achieve the primary endpoint. The failure to meet the primary endpoint may have been due to the large number of patients with immunological high-risk backgrounds, acute rejection, and the treatment of such patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-27
• Study Completion: 2022-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Recipient
1) decompensated liver cirrhotic patients who will receive liver transplantation
2) 20 years old or older
3) written informed consent from patients or legal guardian

Exclusion Criteria

1) patients who will receive re-transplantation
2) patients who will receive deceased donor liver transplantation
3) patients whom the researchers decided as inappropriate to be participated

Study & Design

• Study Type: Interventional
• Study Design: Not specified