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

NCT ID: NCT06071143

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-09-30

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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KDSTEM Inj.

1. Low dose : Urine derived stem cells 1.0x10^8 cells

2. High dose : Urine derived stem cells 3.0x10^8 cells

Group Type: EXPERIMENTAL

KDSTEM Inj.

Intervention Type: BIOLOGICAL

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)

Interventions

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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EHL Bio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dae-Eun Choi, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

haebin kim

Role: CONTACT

haebin1204@ehlbio.com

+82.70.5001.3630

junseok seo

Role: CONTACT

seokehl@ehlbio.com

+82.70.5038.1940

Facility Contacts

Dae-Eun Choi, M.D,Ph.D

Role: primary

Other Identifiers

101473

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KD-CP-22-1

Identifier Type: -

Identifier Source: org_study_id