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

Pharmicell

Status: Active, not recruiting

Conditions: Renal Insufficiency, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT05096182

PMC-P-12-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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