NCT06071143CompletedPhase 1
Safety and Efficacy of 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
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 3 Oct 2023
- Start date
- 29 Feb 2024
- Primary completion date
- 9 Mar 2026
- Lead sponsor
- EHL Bio Co., Ltd.
- Diseases
- Chronic kidney disease
- NCT number
- NCT06071143
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 29 Feb 2024 to the primary completion date, 9 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials
Other illness
- Subjects who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.