Chronic Kidney DiseasePhase 1NCT05042206
Phase 1 Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells in Chronic Kidney Disease
A Phase 1 study testing Cellgram-CKD in people with Chronic Kidney Disease, run by Pharmicell Co., Ltd. at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the safety of Cellgram-CKD in patients with chronic kidney disease over 12 months after three administrations. The main question it aims to answer is: What medical problems do participants have after receiving Cellgram-CKD? Participants will: Receive Cellgram-CKD by… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Cellgram-CKD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2021to 21 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female participants aged 19 to less than 80 years.
- Participants diagnosed with Stage 3b or Stage 4 chronic kidney disease (CKD) [eGFR 15-44 mL/min/1.73 m²] within 1 year prior to screening.
- Participants who voluntarily agree to participate in the clinical trial and provide written informed consent.
Who cannot join
- Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
- Those with the following medical history/comorbidities A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive disorder, dementia or psychiatric disorder D. Alcohol or drug abuse E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) F. Stroke G. Systemic autoimmune disease
- Those whose test results fall under the following at the screening visit A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive B. Uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg) C. AST and ALT ≥ upper limit of normal x 3.0 D. Total bilirubin ≥ upper limit of normal x 1.5
- At screening, those who have the following treatment history A. Those who are being treated for severe systemic infection B. Those who have been treated with immunosuppressant within 28 days prior to screening
- Those with a history of renal transplantation
- Those who have received dialysis within 3 months prior to the screening visit or who are planning to undergo dialysis during the clinical trial period
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- Pregnant, lactating, or planning during clinical trials
- Those who do not agree to comply with the contraceptive method specified in this protocol during the clinical trial period
- Those who are receiving drugs that are expected to affect the results of this clinical trial when judged by the investigator
- Those who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received investigational products/medical devices for investigational use or received procedures
- Those who have or are planning to administer other cell therapy products
- Those who are judged by the investigator to be inappropriate to participate in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Patients With Chronic Kidney Disease
The goal of this clinical trial is to evaluate the safety of Cellgram-CKD in patients with chronic kidney disease over 12 months after three administrations. The main question it aims to answer is:
- What medical problems do participants have after receiving Cellgram-CKD?
Participants will:
- Receive Cellgram-CKD by intravenous infusion three times at 2-week intervals. Visit the clinic 1, 3, 6, 9, and 12 months after the third administration for safety assessments.
Read the detailed description
The screening test is performed after the clinical trial subject consents in writing to participate in the clinical trial. Subjects who meet the inclusion/exclusion criteria are registered in the clinical trial, and Cellgram-CKD is injected intravenously by puncturing a vein with a needle. After injecting Cellgram-CKD three times at an interval of 2 weeks (14 days), the subject visits the testing institution at 1 month, 3 months, 6 months, 9 months and 12 months for safety evaluation. However, since the safety of Cellgram-CKD has not been established, proceed as follows. In the first 3 subjects who received the investigational product, if no adverse events of Grade 3 or higher according to the NCI-CTCAE related to the investigational product occur 14 days after the 1st and 2nd administration, and 1 month after the 3rd administration, the remaining subjects were sequentially treated. Register as a member and conduct clinical trials. If an adverse event of Grade 3 or higher according to the NCI-CTCAE standard related to the test drug occurs in two of the first three subjects, the clinical trial is terminated early. is conducted by registering three additional test subjects in the same way as the first. If one or more of the three subjects develops a Grade 3 or higher adverse event related to the investigational product, the clinical trial is terminated early, and the remaining subjects are treated only if all three subjects do not have a Grade 3 or higher adverse reaction related to the investigational product. Register to continue the clinical trial.
- Conditions
- Chronic Kidney Disease
- Being tested
- Cellgram-CKD
- Keywords
- Cellgram-CKD, Chronic Kidney Disease, Mesenchymal Stem Cells, Chronic Kidney Disease Stage 3b, Chronic Kidney Disease Stage 4, Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellgram-CKDBiological
5 × 10^7 allogeneic bone marrow-derived mesenchymal stem cells (10 mL) administered by intravenous infusion three times at 2-week (14-day) intervals.
| Study group | Role | What they receive |
|---|---|---|
| Cellgram-CKD | Experimental | Participants receive 5 × 10^7 allogeneic bone marrow-derived mesenchymal stem cells (10 mL) by intravenous infusion three times at 2-week (14-day) intervals. Receives: Biological: Cellgram-CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Measured: From the first administration of the investigational product to 12 months after the third administration of the investigational product.
Secondary outcomes (2)
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
The change in estimated glomerular filtration rate (eGFR) from baseline will be assessed at 1, 3, 6, 9, and 12 months after administration of the investigational product.
Measured: 1, 3, 6, 9, and 12 months after administration of the investigational product.
Change in Blood Urea Nitrogen (BUN) and Creatinine From Baseline
The changes in blood urea nitrogen (BUN) and creatinine from baseline will be assessed at 1, 3, 6, 9, and 12 months after administration of the investigational product.
Measured: 1, 3, 6, 9, and 12 months after administration of the investigational product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start24 Nov 2021
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Hyosang, Principal investigator, Asan Medical Center Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042206
- Sponsor's protocol ID
- PMC-P-12
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05042206
- Acronym / sponsor ID
- PMC-P-12
- Conditions
- Chronic Kidney Disease
- Keywords
- Cellgram-CKD, Chronic Kidney Disease, Mesenchymal Stem Cells, Chronic Kidney Disease Stage 3b, Chronic Kidney Disease Stage 4, Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 13 Sep 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.
The goal of this clinical trial is to evaluate the safety of Cellgram-CKD in patients with chronic kidney disease over 12 months after three administrations. The main question it aims to answer is:
- What medical problems do participants have after receiving Cellgram-CKD?
Participants will:
- Receive Cellgram-CKD by intravenous infusion three times at 2-week intervals. Visit the clinic 1, 3, 6, 9, and 12 months after the third administration for safety assessments.
Detailed description
The screening test is performed after the clinical trial subject consents in writing to participate in the clinical trial. Subjects who meet the inclusion/exclusion criteria are registered in the clinical trial, and Cellgram-CKD is injected intravenously by puncturing a vein with a needle. After injecting Cellgram-CKD three times at an interval of 2 weeks (14 days), the subject visits the testing institution at 1 month, 3 months, 6 months, 9 months and 12 months for safety evaluation. However, since the safety of Cellgram-CKD has not been established, proceed as follows. In the first 3 subjects who received the investigational product, if no adverse events of Grade 3 or higher according to the NCI-CTCAE related to the investigational product occur 14 days after the 1st and 2nd administration, and 1 month after the 3rd administration, the remaining subjects were sequentially treated. Register as a member and conduct clinical trials. If an adverse event of Grade 3 or higher according to the NCI-CTCAE standard related to the test drug occurs in two of the first three subjects, the clinical trial is terminated early. is conducted by registering three additional test subjects in the same way as the first. If one or more of the three subjects develops a Grade 3 or higher adverse event related to the investigational product, the clinical trial is terminated early, and the remaining subjects are treated only if all three subjects do not have a Grade 3 or higher adverse reaction related to the investigational product. Register to continue the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cellgram-CKD | Experimental | Biological: Cellgram-CKDParticipants receive 5 × 10^7 allogeneic bone marrow-derived mesenchymal stem cells (10 mL) by intravenous infusion three times at 2-week (14-day) intervals. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants aged 19 to less than 80 years.
- Participants diagnosed with Stage 3b or Stage 4 chronic kidney disease (CKD) [eGFR 15-44 mL/min/1.73 m²] within 1 year prior to screening.
- Participants who voluntarily agree to participate in the clinical trial and provide written informed consent.
Key exclusion criteria (12 listed)
- Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
- Those with the following medical history/comorbidities A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive disorder, dementia or psychiatric disorder D. Alcohol or drug abuse E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) F. Stroke G. Systemic autoimmune disease
- Those whose test results fall under the following at the screening visit A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive B. Uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg) C. AST and ALT ≥ upper limit of normal x 3.0 D. Total bilirubin ≥ upper limit of normal x 1.5
- At screening, those who have the following treatment history A. Those who are being treated for severe systemic infection B. Those who have been treated with immunosuppressant within 28 days prior to screening
- Those with a history of renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellgram-CKD5 × 10^7 allogeneic bone marrow-derived mesenchymal stem cells (10 mL) administered by intravenous infusion three times at 2-week (14-day) intervals. | Biological | Cellgram-CKD |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From the first administration of the investigational product to 12 months after the third administration of the investigational product.
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
2 secondary outcomes
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
Time frame: 1, 3, 6, 9, and 12 months after administration of the investigational product.
Change in Blood Urea Nitrogen (BUN) and Creatinine From Baseline
Time frame: 1, 3, 6, 9, and 12 months after administration of the investigational product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Kim Hyosang principal investigator
Asan Medical Center Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cellgram-CKD in people with 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 3 inclusion and 12 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: finished, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Adverse Events (AEs) (time frame: From the first administration of the investigational product to 12 months after the third administration of the investigational product.). 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.