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Clinical Trials/NCT05096182
NCT05096182Active, not recruitingNot Applicable

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

Pharmicell Co., Ltd.1 site in 1 country10 target enrollmentStarted: March 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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