Status:
RECRUITING
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
Lead Sponsor:
EHL Bio Co., Ltd.
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
19-80 years
Phase:
PHASE1
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 Pati...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06071143
Start Date
February 29 2024
End Date
September 1 2025
Last Update
March 18 2024
Active Locations (1)
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1
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea