Actively Recruiting
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
Led by DALIM TISSEN Co., Ltd. · Updated on 2026-01-20
194
Participants Needed
5
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years and older
- Diagnosed with unilateral or bilateral knee osteoarthritis based on American College of Rheumatology criteria with at least three of these: age 50 or older, morning stiffness under 30 minutes, crepitus on motion, bony tenderness, bony enlargement, no palpable warmth
- Radiographic evidence of Kellgren-Lawrence grade I, II, or III osteoarthritis within 6 months before screening or at screening
- Weight-bearing pain score of 40 mm or higher on a 100-mm visual scale in at least one knee at screening
- Able to walk without assistive devices, or if using a walking aid routinely for the past 6 months, able to continue using the same device throughout the study
- Able to understand and complete assessment questionnaires
- Willing and able to provide written informed consent
You will not qualify if you...
- Body mass index of 32 kg/m2 or higher
- Chronic inflammatory joint diseases such as rheumatoid arthritis
- Inflammatory joint diseases like septic arthritis
- Secondary knee osteoarthritis due to ochronosis, hemochromatosis, or systemic diseases
- Painful musculoskeletal conditions such as Sudeck's atrophy, Paget's disease, or herniated disc
- Severe osteoarthritis in other joints 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 serious heart disease or uncontrolled high blood pressure despite treatment
- History of autoimmune disease
- Active infection needing parenteral antibiotics
- History of psychiatric disorder or epilepsy
- Cancer diagnosis within 5 years before screening
- Uncontrolled diabetes with HbA1c over 7%
- Surgery on target knee within 1 year
- Intra-articular corticosteroid injection into target knee within 12 weeks
- Systemic corticosteroid use within 4 weeks
- Surgery or radiation therapy to knee within 12 weeks or not fully recovered
- Immunosuppressive therapy within 6 weeks
- Intra-articular injections like hyaluronic acid into knee within 6 months
- Use of prohibited medications including certain anticoagulants and psychoactive drugs
- History or planned cell or gene therapy to target joint
- Abnormal lab values for liver or kidney function at screening
- Engaged in high-intensity exercise that may affect knee joint
- Skin disease at injection site or unsuitable injection site
- Ligament instability of grade II or higher in target knee
- Known allergy to study product or components
- Pregnant or breastfeeding women
- Women or men of childbearing potential unwilling to use contraception
- Participation in another clinical trial within 4 weeks
- Cognitive impairment or dementia preventing consent
- Any condition making participation unsuitable by investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, South Korea, 13620
Actively Recruiting
2
CHA Bundang Medical Center
Seoul, Bundang-gu, South Korea, 13496
Actively Recruiting
3
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea, 03312
Actively Recruiting
4
Gachon University Gil Hospital
Seoul, Namdong-gu, South Korea, 21565
Actively Recruiting
5
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Seochogu, South Korea, 06591
Actively Recruiting
Research Team
H
Hyunjin Bae Dream CIS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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