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

N/AActive Not RecruitingNCT05096182

Pharmicell Co., Ltd.10 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Renal Insufficiency, Chronic

Eligibility

Sex: ALLMin age: 19 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Observe the occurrence of Adverse Event of Special Interest (AESI).

AESI stands for Serious Adverse Event as follows. 1. death 2. Creation of neoplasms or malignancies in tissues or organs 3. The development of an immune response, including the exacerbation or new development of a previous autoimmune disease 4. Occurrence of Other delayed adverse events related to stem cell therapy

Time frame: 5 years from the date of administration of Cellgram-CKD

Data from ClinicalTrials.gov

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