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

NCT06539429 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: ANT-301-102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Safety assessment

  Number of Adverse events and Laboratory Abnormalities

  Week 2, 4, 8, 12, 24 and Month 12

Secondary Outcomes (3)

• Pain improvement according to VAS scale measurements

  Baseine, Week 4, 8, 12, 24 and Month 12

• IKDC score

  Baseline, Week 4, 8, 12, 24 and 12 months

• WOMAC questionnaire score

  Baseline, Week 4, 8, 12, 24 and 12 months

Study Arms (1)

ANT-301

EXPERIMENTAL

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

Biological: ANT-301

Interventions

ANT-301 BIOLOGICAL

Administration on Day 1

ANT-301

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

Seoul National University

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: April 30, 2024
• First Posted: August 6, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)