NCT05096182

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2022Mar 2027

First Submitted

Initial submission to the registry

October 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

October 15, 2021

Last Update Submit

March 21, 2024

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

  • Observe the occurrence of Adverse Event of Special Interest (AESI).

    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

    5 years from the date of administration of Cellgram-CKD

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic kidney disease who participated in the PMC-P-12 clinical trial, among those who received Cellgram-CKD, those who agreed to participate in this long-term follow-up study

You may qualify if:

  • 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

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hyosang Kim

    Asan Medical Center Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 27, 2021

Study Start

March 10, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 25, 2024

Record last verified: 2024-03

Locations

KR(1)