Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L

NCT ID: NCT06539429

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Design: open-label, single-center, dose-escalation study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ANT-301

Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel

Group Type EXPERIMENTAL

ANT-301

Intervention Type BIOLOGICAL

Administration on Day 1

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ANT-301

Administration on Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
2. Patients aged 19 to 70 years old.
3. Patients diagnosed with K\&L grade III/IV knee osteoarthritis
4. Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale

Exclusion Criteria

1. Patients with joint diseases other than osteoarthritis
2. Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
3. Patients who received intra-articular injections within 6 months prior to the screening
4. Patients who have received systemic steroid therapy within 3 months prior to the screening
5. Patients who have received immunosuppressive agents within 3 months prior to the screening
6. Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
7. Patients who are unwilling to use contraception during the clinical trial period
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anterogen Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANT-301-102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.