A Phase 1 interventional study of KDSTEM Inj. in Chronic Kidney Diseases, sponsored by EHL Bio Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by EHL Bio Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's enrollment of 6 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →EHL Bio Co., Ltd. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who meet any of the following conditions at the screening visit
Subjects diagnosed with the following diseases
1. Low dose : Urine derived stem cells 1.0x10\^8 cells 2. High dose : Urine derived stem cells 3.0x10\^8 cells
Biological: 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)
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
Time frame: 28 weeks follow-up after first injection
eGFR
The variation in eGFR at each measurement compared to baseline measurement.
Time frame: From the first injection until 28 weeks later
BUN
The variation in BUN at each measurement compared to baseline measurement.
Time frame: From the first injection until 28 weeks later
Serum creatinine
The variation in Serum creatinine at each measurement compared to baseline measurement.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: The first administration time, 4 weeks and 24 weeks after the third administration.
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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EHL Bio Co., Ltd.