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

NCT06071143 | Recruiting Phase 1

• 2 other identifiers: KD-CP-22-1101473
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

CKD; Urine-derived Stem cell; stem cell; EHLBIO; UDSC

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• eGFR

  From the first injection until 28 weeks later

• BUN

  From the first injection until 28 weeks later

• 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

Study Arms (1)

KDSTEM Inj.

EXPERIMENTAL

1. Low dose : Urine derived stem cells 1.0x10\^8 cells 2. High dose : Urine derived stem cells 3.0x10\^8 cells

Biological: KDSTEM Inj.

Interventions

KDSTEM Inj. 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)

KDSTEM Inj.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EHL Bio Co., Ltd.: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dae-Eun Choi, M.D, Ph.D

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

haebin kim

CONTACT

+82.70.5001.3630; haebin1204@ehlbio.com

junseok seo

CONTACT

+82.70.5038.1940; seokehl@ehlbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 6, 2023
• Study Start: February 29, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)