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

March 14, 2024 updated by: EHL Bio Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Chungcheongnam-do
      • Daejeon, Chungcheongnam-do, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Dae-Eun Choi, M.D,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KDSTEM Inj.
  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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Time Frame: 28 weeks follow-up after first injection
vital sign, laboratory findings, physical exam, chest x-ray, cardiography, adverse drug reactions
28 weeks follow-up after first injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR
Time Frame: From the first injection until 28 weeks later
The variation in eGFR at each measurement compared to baseline measurement.
From the first injection until 28 weeks later
BUN
Time Frame: From the first injection until 28 weeks later
The variation in BUN at each measurement compared to baseline measurement.
From the first injection until 28 weeks later
Serum creatinine
Time Frame: From the first injection until 28 weeks later
The variation in Serum creatinine at each measurement compared to baseline measurement.
From the first injection until 28 weeks later
UPCR
Time Frame: From the first injection until 28 weeks later
The variation and the rate of Change in UPCR at Each measurement compared to baseline measurement.
From the first injection until 28 weeks later
UACR
Time Frame: From the first injection until 28 weeks later
The variation and the rate of Change in UACR at Each measurement compared to baseline measurement.
From the first injection until 28 weeks later
NGAL(Neutrophil Gelatinase Associated Lipocalin)
Time Frame: The first administration time, 4 weeks and 24 weeks after the third administration.
Changes in NGAL (urine) and NGAL (plasma) at 4 weeks, 24 weeks measurement time after third injection compared to baseline
The first administration time, 4 weeks and 24 weeks after the third administration.
IL-6, IL-8, CCL18, TNF-α, α-Klotho
Time Frame: The first administration time, 4 weeks and 24 weeks after the third administration.
Changes in IL-6, IL-8, CCL18, TNF-α, α-Klotho at 4 weeks, 24 weeks measurement time after third injection compared to baseline
The first administration time, 4 weeks and 24 weeks after the third administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EHL Bio Co., Ltd.

Investigators

  • Principal Investigator: Dae-Eun Choi, M.D, Ph.D, Chungnam National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD-CP-22-1
  • 101473 (Other Grant/Funding Number: Republic of Korea Ministry of Food and Durg Safety)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on KDSTEM Inj.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe