Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pharmicell Co., Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Observe the occurrence of Adverse Event of Special Interest (AESI).
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Observe the occurrence of Adverse Event of Special Interest (AESI).
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported