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Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease

NCT06071143 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases

Interventions

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)

Sponsors & Collaborators

  • EHL Bio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dae-Eun Choi, M.D, Ph.D · Chungnam National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-04-30
Completion
2025-09-30

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06071143 on ClinicalTrials.gov