RecruitingPhase 1NCT06071143

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

Sponsor

EHL Bio Co., Ltd.

Enrollment

6 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases

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. 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.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests an injectable stem cell treatment called KDSTEM for people with moderate chronic kidney disease — a condition where the kidneys gradually lose their ability to filter waste from the blood. Researchers are checking whether the treatment is safe and whether it can slow or reverse kidney decline. **You may be eligible if...** - You are between 19 and 80 years old - You have chronic kidney disease with a kidney filtration rate (eGFR) between 20 and 59 mL/min — meaning moderate kidney disease - You are willing to use reliable birth control during the study (if of childbearing age) - You have given written consent to participate **You may NOT be eligible if...** - You are on dialysis or your kidney disease is very advanced - You have certain autoimmune conditions, active infections, or serious other illnesses - You are pregnant or breastfeeding - You have had a recent organ transplant or certain cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALKDSTEM 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)