Chronic Kidney DiseaseNCT05096182
Long-Term Follow-up of Patients With Chronic Kidney Disease Treated With Cellgram-CKD
An observational study of Chronic Kidney Disease, run by Pharmicell Co., Ltd. at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P12 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).
Read the 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.
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years from the date of administration of Cellgram-CKD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start10 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyosang Kim, Principal investigator, Asan Medical Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096182
- Sponsor's protocol ID
- PMC-P-12-01
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P12 Study
- ClinicalTrials.gov ID
- NCT05096182
- Acronym / sponsor ID
- PMC-P-12-01
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyosang Kim principal investigator
Asan Medical Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Pharmicell Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe the occurrence of Adverse Event of Special Interest (AESI). (time frame: 5 years from the date of administration of Cellgram-CKD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.