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Active, Not Recruiting

NCT Number: NCT05096182

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    • 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

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2021
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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