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

NCT07267793 | Recruiting

• 1 other identifier: DLTS_05
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cartilage Defects of the Knee; Knee Osteoarthritis; Degenerative Joint Disease of Knee; Osteoarthritis; Knee Pain Arthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm)

  The change from baseline in Weight-Bearing Pain will be assessed using a 100-mm visual analogue scale ranging from 0 mm, no pain, to 100 mm, worst imaginable pain. Higher scores indicate more severe pain.

  at week 12 after the first administration

Secondary Outcomes (12)

• Change from Baseline in Weight-Bearing Pain Visual Analogue Scale Score (0-100 mm)

  at Weeks 2, 4, and 24 after the first administration

• Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Total and Subscale Scores

  at Weeks 2, 4, 12, and 24 after the first administration

• Change from Baseline in 36-Item Short Form Health Survey Domain Scores (SF-36)

  at Weeks 2, 4, 12, and 24 after the first administration

• Change from Baseline in Rest Pain Visual Analogue Scale Score (0-100 mm)

  at Weeks 2, 4, 12, and 24 after the first administration

• Change from Baseline in Motion Pain Visual Analogue Scale Score (0-100 mm)

  at Weeks 2, 4, 12, and 24 after the first administration

Study Arms (2)

Study Group

EXPERIMENTAL

Group applied with CartiPRO

Drug: Synovian®

Control group

ACTIVE COMPARATOR

Group applied with Synovian®

Device: CartiPRO

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.

Control group

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 Group

Eligibility Criteria

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

You may qualify if:

• Age 19 years and older
• Diagnosed with unilateral or bilateral knee osteoarthritis according to American College of Rheumatology (ACR) criteria, with at least 3 of the following 6 features:
• Age ≥50 years
• Morning stiffness \<30 minutes
• Crepitus on active motion
• Bony tenderness
• Bony enlargement
• No palpable warmth
• Radiographic evidence of Kellgren-Lawrence grade I, II, or III osteoarthritis within 6 months prior to screening or at screening visit
• Weight-bearing pain Visual Analogue Scale (VAS) score ≥40 mm in at least one knee joint at screening
• Able to walk without assistive devices (walkers or canes), OR if using a walking aid routinely for past 6 months, able to continue using the same device throughout the study
• Able to understand and complete efficacy assessment questionnaires
• Willing and able to provide written informed consent

You may not qualify if:

• Body Mass Index (BMI) ≥32 kg/m²
• Chronic inflammatory joint disease (e.g., rheumatoid arthritis)
• Inflammatory joint disease (e.g., septic arthritis)
• Secondary knee osteoarthritis due to ochronosis, hemochromatosis, or systemic disease
• Painful musculoskeletal conditions (e.g., Sudeck's atrophy, Paget's disease, herniated intervertebral disc)
• Polyarticular disease with severe osteoarthritis in other joints (e.g., hip) that may affect knee pain evaluation
• Radiographic evidence of definite loss of patellofemoral joint space
• Moderate to severe joint effusion confirmed by positive patellar tap test or equivalent
• History of myocardial infarction, congestive heart failure, other serious cardiac disease, or uncontrolled hypertension (≥140/90 mmHg despite treatment with ≥3 antihypertensive agents)
• History of autoimmune disease
• Active infection requiring parenteral antibiotics
• History of psychiatric disorder or epilepsy
• Cancer diagnosis within 5 years prior to screening
• Uncontrolled type 1 or type 2 diabetes mellitus (HbA1c \>7%)
• Intra-articular corticosteroid injection into target knee within 12 weeks

Sponsors & Collaborators

• DALIM TISSEN Co., Ltd.: lead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, 13620, South Korea

RECRUITING

CHA Bundang Medical Center

Seoul, Bundang-gu, 13496, South Korea

RECRUITING

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, 03312, South Korea

RECRUITING

Gachon University Gil Hospital

Seoul, Namdong-gu, 21565, South Korea

RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Seochogu, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yong In, Ph.D

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyunjin Bae Dream CIS

CONTACT

+82 2 2010 450; su-bin.lee@tigermedgrp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: July 3, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

KR (5)