Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study
- Conditions
- Renal Insufficiency, Chronic
- Registration Number
- NCT05096182
- Lead Sponsor
- Pharmicell Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- Not Applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center Hospital
🇰🇷Seoul, Korea, Republic of