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).
Eligibility
Sex
ALL
Min age
19 Years
Max age
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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