Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage

Sponsor
DALIM TISSEN Co., Ltd.
Study ID
NCT07267793
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CartiPRO — DEVICE
    Clinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Dalim Tissen's CartiPRO. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.
  • Synovian® — DRUG
    Clinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Synovian®. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.

Study Details

This clinical trial aims to evaluate and compare the efficacy and safety of CartiPRO, an approved intra-articular atelocollagen injection, versus Synovian injection for the relief of knee pain in patients with knee osteoarthritis. The investigational device is administered intra-articularly, with a second injection given 24 weeks after the first dose. Primary and secondary endpoints include changes in pain scores (VAS), functional assessments (WOMAC, SF-36), and safety evaluations over a 36-week period.

Key Dates

First listed
Dec 5, 2025
Start date
Jul 3, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Study Group
    Group applied with CartiPRO
  • Active Comparator: Control group
    Group applied with Synovian®

Primary Outcome Measure

Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm) [ Time Frame: at week 12 after the first administration ]

Central Contacts

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