Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 101473 | Other Grant/Funding Number | Republic of Korea Ministry of Food and Durg Safety |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KDSTEM Inj. | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KDSTEM Inj. | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 weeks follow-up after first injection |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | The variation in eGFR at each measurement compared to baseline measurement. | From the first injection until 28 weeks later |
| BUN | The variation in BUN at each measurement compared to baseline measurement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects who meet any of the following conditions at the screening visit
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dae-Eun Choi, M.D, Ph.D | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Chungcheongnam-do | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From the first injection until 28 weeks later |
| Serum creatinine | The variation in Serum creatinine at each measurement compared to baseline measurement. | From the first injection until 28 weeks later |
| UPCR | 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 | 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) | 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 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |