NCT05096182

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Pharmicell Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2022-03-10
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2021-10-27
• Last updated: 2024-03-25

Locations

1 site across 1 country: South Korea