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

September 19, 2025 updated by: Anterogen Co., Ltd.

Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANT-301
Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel
Biological: ANT-301
Administration on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessment
Time Frame: Week 2, 4, 8, 12, 24 and Month 12
Number of Adverse events and Laboratory Abnormalities
Week 2, 4, 8, 12, 24 and Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain improvement according to VAS scale measurements
Time Frame: Baseine, Week 4, 8, 12, 24 and Month 12
The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.
Baseine, Week 4, 8, 12, 24 and Month 12
IKDC score
Time Frame: Baseline, Week 4, 8, 12, 24 and 12 months
IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Baseline, Week 4, 8, 12, 24 and 12 months
WOMAC questionnaire score
Time Frame: Baseline, Week 4, 8, 12, 24 and 12 months
Difference in WOMAC questionnaire scores between baseline and each visit
Baseline, Week 4, 8, 12, 24 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANT-301-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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