Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study

NCT ID: NCT05096182

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2027-03-31

Brief Summary

This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206).

Detailed Description

This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206).

The long-term safety of Cellgram-CKD is evaluated by monitoring whether or not an adverse event of special interest (AESI) occurs for 5 years from the date of administration in Cellgram-CKD subjects who voluntarily consented in writing to participate in the long-term follow-up study.

Conditions

Renal Insufficiency, Chronic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Those who participated in the PMC-P-12 clinical trial and received Cellgram-CKD
• Subjects who consented in writing to this long-term follow-up study

Exclusion Criteria

• Not Applicable

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyosang Kim

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center Hospital

Locations

Asan Medical Center Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PMC-P-12-01

Identifier Type: -

Identifier Source: org_study_id