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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- EHL Bio Co., Ltd.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- BUN(From the first injection until 28 weeks later)
- IL-6, IL-8, CCL18, TNF-α, α-Klotho(The first administration time, 4 weeks and 24 weeks after the third administration.)
- Serum creatinine(From the first injection until 28 weeks later)
- UPCR(From the first injection until 28 weeks later)
- UACR(From the first injection until 28 weeks later)
- eGFR(From the first injection until 28 weeks later)
- NGAL(Neutrophil Gelatinase Associated Lipocalin)(The first administration time, 4 weeks and 24 weeks after the third administration.)