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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05096182
• Other study ID #: PMC-P-12-01
• Status: Active, not recruiting
• Start date: March 10, 2022
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observe the occurrence of Adverse Event of Special Interest (AESI).	AESI stands for Serious Adverse Event as follows.; death; Creation of neoplasms or malignancies in tissues or organs; The development of an immune response, including the exacerbation or new development of a previous autoimmune disease; Occurrence of Other delayed adverse events related to stem cell therapy	5 years from the date of administration of Cellgram-CKD