Evaluating a new treatment for chronic kidney disease using urine-derived stem cells
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
This study is testing if using stem cells from urine can help people with chronic kidney disease feel better and improve their kidney function.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | EHL Bio Co., Ltd. Industry-sponsored |
| Locations | 1 site (Daejeon, Chungcheongnam-do) |
| Trial ID | NCT06071143 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-arm, open-labelled, dose-escalation Phase 1 study aimed at assessing the safety, tolerability, and preliminary efficacy of autologous urine-derived stem cells, known as KDSTEM Inj., in patients with Chronic Kidney Disease (CKD). Participants will undergo necessary examinations to determine eligibility before receiving intravenous doses of the investigational product over a series of visits. Safety and efficacy assessments will be conducted at multiple intervals over a 24-week period following the first administration. The study seeks to provide initial insights into the potential benefits of this innovative treatment approach for CKD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 to 80 with chronic kidney disease and an eGFR of 20 to 59 ml/min/1.73m².
Not a fit: Patients with systemic infections, recent hemodialysis, or those with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel therapeutic option for patients suffering from chronic kidney disease.
How similar studies have performed: While this approach is innovative, similar studies using stem cells for kidney disease have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged between 19 and 80 at the time of signing the agreement 2. Chronic kidney disease patients with an eGFR of 20 to 59 ml/min/1.73m² by MDRD at the screening and baseline 3. Male or female of childbearing age agreed to use accurate birth control method during this clinical trial 4. Subjects voluntarily signed an agreement in writing for this clinical trial Exclusion Criteria: 1. Subjects who meet any of the following conditions at the screening visit 1. Systemic infection 2. HIV, HBV, HCV, Syphilis (+) 3. Blood pressure higher than 190mmHg of SBP or 110mmHg of DBP 4. AST or ALT higher than 3 times the upper limit of normal values 2. Subjects who received hemodialysis within 12 weeks prior to the screening or will be receive hemodialysis during this clinical trial 3. Subjects who received kidney transplantation or will be receive kidney transplantation during this clinical trial 4. Subjects diagnosed with the following diseases 1. Solid Tumors or Hematologic Malignancies within 5 years prior to the screening 2. Cognitive disorder, Alzheimer's disease or mental illness be clinically significant. 3. Alcohol or drug abuse 4. Severe Respiratory disease (Chronic Obstructive Pulmonary Disease, asthma, pneumonia, pulmonary embolism and pneumothorax, etc.) 5. Stroke 6. Heart related diseases (within 3 months prior to the screening severe cardiovascular conditions (angina Pectoris, myocardial infarction, unstable arrhythmia, heart failure, etc.) 5. Subjects who received cell therapy or another clinical trial product/device within 4 weeks prior to the screening 6. Subjects who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B 7. Subjects, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials 8. Subjects being pregnant, providing breast milk, resulted in positive pregnancy test at screening or planning for pregnancy during this clinical trial 9. etc. Subjects determined unsuitable for this clinical trial by the investigator
Where this trial is running
Daejeon, Chungcheongnam-do
- Chungnam National University Hospital — Daejeon, Chungcheongnam-do, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Dae-Eun Choi, M.D, Ph.D — Chungnam National University Hospital
- Study coordinator: haebin kim
- Email: haebin1204@ehlbio.com
- Phone: +82.70.5001.3630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.