Chronic Kidney DiseasesPhase 1NCT06071143
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
A Phase 1 study testing KDSTEM Inj. in people with Chronic Kidney Diseases, run by EHL Bio Co., Ltd. at 1 site in South Korea.
Trial summary
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney Disease. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- KDSTEM Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Feb 2024to 9 Mar 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 19 and 80 at the time of signing the agreement
- Chronic kidney disease patients with an eGFR of 20 to 59 ml/min/1.73m² by MDRD at the screening and baseline
- Male or female of childbearing age agreed to use accurate birth control method during this clinical trial
- Subjects voluntarily signed an agreement in writing for this clinical trial
Who cannot join
- Subjects who meet any of the following conditions at the screening visit
- Systemic infection
- HIV, HBV, HCV, Syphilis (+)
- Blood pressure higher than 190mmHg of SBP or 110mmHg of DBP
- AST or ALT higher than 3 times the upper limit of normal values
- Subjects who received hemodialysis within 12 weeks prior to the screening or will be receive hemodialysis during this clinical trial
Show all 19Show fewer
- Subjects who received kidney transplantation or will be receive kidney transplantation during this clinical trial
- Subjects diagnosed with the following diseases
- Solid Tumors or Hematologic Malignancies within 5 years prior to the screening
- Cognitive disorder, Alzheimer's disease or mental illness be clinically significant.
- Alcohol or drug abuse
- Severe Respiratory disease (Chronic Obstructive Pulmonary Disease, asthma, pneumonia, pulmonary embolism and pneumothorax, etc.)
- Stroke
- Heart related diseases (within 3 months prior to the screening severe cardiovascular conditions (angina Pectoris, myocardial infarction, unstable arrhythmia, heart failure, etc.)
- Subjects who received cell therapy or another clinical trial product/device within 4 weeks prior to the screening
- Subjects who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B
- Subjects, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials
- Subjects being pregnant, providing breast milk, resulted in positive pregnancy test at screening or planning for pregnancy during this clinical trial
- etc. Subjects determined unsuitable for this clinical trial by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Chungcheongnam-do
About this study
Official title: A Single Arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients With Chronic Kidney Disease
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney Disease.
The aim of this study is to evaluate the safety and preliminary efficacy of KDSTEM Inj. in the treatment in Patients with Chronic Kidney Disease.
Read the detailed description
This clinical trial is a single-arm, open-labelled, dose-escalation, single-center Phase 1 study. Its aim is to evaluate the safety, tolerability, and preliminary efficacy of autologous urine-derived stem cells in patients with Chronic Kidney Disease.
If subjects voluntarily sign a written agreement to participate in this clinical trial, the subjects shall undergo the necessary examinations, as outlined in the clinical trial protocol, approximately one month prior to the administration of the investigational product.
After assessing the suitability of the subjects and ensuring participants meet the inclusion/exclusion criteria, eligible subjects will be assigned to different treatment arms. Subjects determined eligible by the investigator for receiving the investigational product on the scheduled administration day will receive a intravenous dose of the investigational product in visit 2, visit 3, and visit 4.
Safety and Efficacy assessments are conducted at 4, 8, 12, 16, 20, and 24 weeks after from the first administration to last administration of the investigational product, spanning a total of 24 weeks.
After all the subjects have completed visit 10, Safety and Efficacy will be analyzed.
- Conditions
- Chronic Kidney Diseases
- Being tested
- KDSTEM Inj.
- Keywords
- CKD, Urine-derived Stem cell, stem cell, EHLBIO, UDSC
- 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.
KDSTEM Inj.Biological
- Low dose: The following study drugs are pre-mixed with 90mL of 0.9% normal saline and injected intravenously three times over the duration of the study. (Treatment group: KDSTEM Inj. 1.0x10^8 cells/10mL/2 syringes)
- High dose: The following study drugs are pre-mixed with 70mL of 0.9% normal saline and injected intravenously three times over the duration of the study. (Treatment group: KDSTEM Inj. 3.0x10^8 cells/30mL/6 syringes)
| Study group | Role | What they receive |
|---|---|---|
| KDSTEM Inj. | Experimental | 1. Low dose : Urine derived stem cells 1.0x10^8 cells
2. High dose : Urine derived stem cells 3.0x10^8 cells Receives: Biological: KDSTEM Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
vital sign, laboratory findings, physical exam, chest x-ray, cardiography, adverse drug reactions
Measured: 28 weeks follow-up after first injection
Secondary outcomes (7)
eGFR
The variation in eGFR at each measurement compared to baseline measurement.
Measured: From the first injection until 28 weeks later
BUN
The variation in BUN at each measurement compared to baseline measurement.
Measured: From the first injection until 28 weeks later
Serum creatinine
The variation in Serum creatinine at each measurement compared to baseline measurement.
Measured: From the first injection until 28 weeks later
UPCR
The variation and the rate of Change in UPCR at Each measurement compared to baseline measurement.
Measured: From the first injection until 28 weeks later
UACR
The variation and the rate of Change in UACR at Each measurement compared to baseline measurement.
Measured: From the first injection until 28 weeks later
NGAL(Neutrophil Gelatinase Associated Lipocalin)
Changes in NGAL (urine) and NGAL (plasma) at 4 weeks, 24 weeks measurement time after third injection compared to baseline
Measured: The first administration time, 4 weeks and 24 weeks after the third administration.
IL-6, IL-8, CCL18, TNF-α, α-Klotho
Changes in IL-6, IL-8, CCL18, TNF-α, α-Klotho at 4 weeks, 24 weeks measurement time after third injection compared to baseline
Measured: The first administration time, 4 weeks and 24 weeks after the third administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start29 Feb 2024
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- EHL Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dae-Eun Choi, M.D, Ph.D, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071143
- Sponsor's protocol ID
- KD-CP-22-1
- Other IDs
- 101473
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2023
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06071143
- Acronym / sponsor ID
- KD-CP-22-1
- Conditions
- Chronic Kidney Diseases
- Keywords
- CKD, Urine-derived Stem cell, stem cell, EHLBIO, UDSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- EHL Bio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 6 Oct 2023 (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.
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney Disease.
The aim of this study is to evaluate the safety and preliminary efficacy of KDSTEM Inj. in the treatment in Patients with Chronic Kidney Disease.
Detailed description
This clinical trial is a single-arm, open-labelled, dose-escalation, single-center Phase 1 study. Its aim is to evaluate the safety, tolerability, and preliminary efficacy of autologous urine-derived stem cells in patients with Chronic Kidney Disease.
If subjects voluntarily sign a written agreement to participate in this clinical trial, the subjects shall undergo the necessary examinations, as outlined in the clinical trial protocol, approximately one month prior to the administration of the investigational product.
After assessing the suitability of the subjects and ensuring participants meet the inclusion/exclusion criteria, eligible subjects will be assigned to different treatment arms. Subjects determined eligible by the investigator for receiving the investigational product on the scheduled administration day will receive a intravenous dose of the investigational product in visit 2, visit 3, and visit 4.
Safety and Efficacy assessments are conducted at 4, 8, 12, 16, 20, and 24 weeks after from the first administration to last administration of the investigational product, spanning a total of 24 weeks.
After all the subjects have completed visit 10, Safety and Efficacy will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KDSTEM Inj. | Experimental | Biological: KDSTEM Inj.1. Low dose : Urine derived stem cells 1.0x10^8 cells 2. High dose : Urine derived stem cells 3.0x10^8 cells |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged between 19 and 80 at the time of signing the agreement
- Chronic kidney disease patients with an eGFR of 20 to 59 ml/min/1.73m² by MDRD at the screening and baseline
- Male or female of childbearing age agreed to use accurate birth control method during this clinical trial
- Subjects voluntarily signed an agreement in writing for this clinical trial
Key exclusion criteria (19 listed)
- Subjects who meet any of the following conditions at the screening visit
- Subjects who received hemodialysis within 12 weeks prior to the screening or will be receive hemodialysis during this clinical trial
- Subjects who received kidney transplantation or will be receive kidney transplantation during this clinical trial
- Subjects diagnosed with the following diseases
- Subjects who received cell therapy or another clinical trial product/device within 4 weeks prior to the screening
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 |
|---|---|---|
| KDSTEM Inj.1. Low dose: The following study drugs are pre-mixed with 90mL of 0.9% normal saline and injected intravenously three times over the duration of the study. (Treatment group: KDSTEM Inj. 1.0x10^8 cells/10mL/2 syringes) 2. High dose: The following study drugs are pre-mixed with 70mL of 0.9% normal saline and injected intravenously three times over the duration of the study. (Treatment group: KDSTEM Inj. 3.0x10^8 cells/30mL/6 syringes) | Biological | KDSTEM Inj. |
Primary outcome
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Time frame: 28 weeks follow-up after first injection
vital sign, laboratory findings, physical exam, chest x-ray, cardiography, adverse drug reactions
7 secondary outcomes
eGFR
Time frame: From the first injection until 28 weeks later
BUN
Time frame: From the first injection until 28 weeks later
Serum creatinine
Time frame: From the first injection until 28 weeks later
UPCR
Time frame: From the first injection until 28 weeks later
UACR
Time frame: From the first injection until 28 weeks later
NGAL(Neutrophil Gelatinase Associated Lipocalin)
Time frame: The first administration time, 4 weeks and 24 weeks after the third administration.
IL-6, IL-8, CCL18, TNF-α, α-Klotho
Time frame: The first administration time, 4 weeks and 24 weeks after the third administration.
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 17 Jun 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.
Dae-Eun Choi, M.D, Ph.D principal investigator
Chungnam National University Hospital
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 KDSTEM Inj. in people with Chronic Kidney Diseases, run by EHL Bio 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 4 inclusion and 19 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 17 Jun 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?
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0 (time frame: 28 weeks follow-up after first injection). 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 17 Jun 2026.