Back to resultsSafety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Diseases
Status
Not yet recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KDSTEM Inj.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring CKD, Urine-derived Stem cell, stem cell, EHLBIO, UDSC
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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 who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B Subjects, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials 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
Sites / Locations
- Chungnam National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KDSTEM Inj.
Arm Description
Low dose : Urine derived stem cells 1.0x10^8 cells High dose : Urine derived stem cells 3.0x10^8 cells
Outcomes
Primary Outcome Measures
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
vital sign, laboratory findings, physical exam, chest x-ray, cardiography, adverse drug reactions
Secondary Outcome Measures
eGFR
The variation in eGFR at each measurement compared to baseline measurement.
BUN
The variation in BUN at each measurement compared to baseline measurement.
Serum creatinine
The variation in Serum creatinine at each measurement compared to baseline measurement.
UPCR
The variation and the rate of Change in UPCR at Each measurement compared to baseline measurement.
UACR
The variation and the rate of Change in UACR at Each measurement compared to baseline measurement.
NGAL(Neutrophil Gelatinase Associated Lipocalin)
Changes in NGAL (urine) and NGAL (plasma) at 4 weeks, 24 weeks measurement time after third injection compared to baseline
IL-6, IL-8, CCL18, TNF-α, α-Klotho
Changes in IL-6, IL-8, CCL18, TNF-α, α-Klotho at 4 weeks, 24 weeks measurement time after third injection compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06071143
Brief Title
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EHL Bio Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
CKD, Urine-derived Stem cell, stem cell, EHLBIO, UDSC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KDSTEM Inj.
Arm Type
Experimental
Arm Description
Low dose : Urine derived stem cells 1.0x10^8 cells
High dose : Urine derived stem cells 3.0x10^8 cells
Intervention Type
Biological
Intervention Name(s)
KDSTEM Inj.
Intervention Description
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)
High 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. 3.0x10^8 cells/30mL/6 syringes)
Primary Outcome Measure Information:
Title
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Description
vital sign, laboratory findings, physical exam, chest x-ray, cardiography, adverse drug reactions
Time Frame
28 weeks follow-up after first injection
Secondary Outcome Measure Information:
Title
eGFR
Description
The variation in eGFR at each measurement compared to baseline measurement.
Time Frame
From the first injection until 28 weeks later
Title
BUN
Description
The variation in BUN at each measurement compared to baseline measurement.
Time Frame
From the first injection until 28 weeks later
Title
Serum creatinine
Description
The variation in Serum creatinine at each measurement compared to baseline measurement.
Time Frame
From the first injection until 28 weeks later
Title
UPCR
Description
The variation and the rate of Change in UPCR at Each measurement compared to baseline measurement.
Time Frame
From the first injection until 28 weeks later
Title
UACR
Description
The variation and the rate of Change in UACR at Each measurement compared to baseline measurement.
Time Frame
From the first injection until 28 weeks later
Title
NGAL(Neutrophil Gelatinase Associated Lipocalin)
Description
Changes in NGAL (urine) and NGAL (plasma) at 4 weeks, 24 weeks measurement time after third injection compared to baseline
Time Frame
The first administration time, 4 weeks and 24 weeks after the third administration.
Title
IL-6, IL-8, CCL18, TNF-α, α-Klotho
Description
Changes in IL-6, IL-8, CCL18, TNF-α, α-Klotho at 4 weeks, 24 weeks measurement time after third injection compared to baseline
Time Frame
The first administration time, 4 weeks and 24 weeks after the third administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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 who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B
Subjects, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
haebin kim
Phone
+82.70.5001.3630
Email
haebin1204@ehlbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
junseok seo
Phone
+82.70.5038.1940
Email
seokehl@ehlbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae-Eun Choi, M.D, Ph.D
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae-Eun Choi, M.D,Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
We'll reach out to this number within 24 hrs