Renal Insufficiency, Chronic
Conditions
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.
Interventions
None listed
Sponsors
Pharmicell Co., Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe the occurrence of Adverse Event of Special Interest (AESI). | 5 years from the date of administration of Cellgram-CKD | 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 |
Countries
South Korea
Outcome results
None listed