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

Phase 1

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: ANT-301

• Registration Number: NCT06539429
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Study Start: 2024-10-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-06
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ANT-301	ANT-301	Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel

Primary Outcome Measures

Name	Time	Method
Safety assessment	Week 2, 4, 8, 12, 24 and Month 12	Number of Adverse events and Laboratory Abnormalities

Secondary Outcome Measures

Name	Time	Method
WOMAC questionnaire score	Baseline, Week 4, 8, 12, 24 and 12 months	Difference in WOMAC questionnaire scores between baseline and each visit
Pain improvement according to VAS scale measurements	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.
IKDC score	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).

Trial Locations

Locations (1)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of