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Long-term Efficacy and Safety of CartiPRO Injection to Alleviate Knee Pain in Patients With Osteoarthritis and/or Diverse Cartilage Defects: a Multicenter, Single-blind, Randomized, Non-inferiority Trial
Led by DALIM TISSEN Co., Ltd. · Updated on 2026-01-20
194
Participants Needed
5
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Knee osteoarthritis is a common joint condition caused by cartilage breakdown, leading to pain, stiffness, and reduced function. This research compares CartiPRO, an approved collagen-based injection, with Synovian injection to assess their effects on knee pain relief in patients with knee osteoarthritis. The study aims to provide strong evidence on the safety and effectiveness of repeated atelocollagen injections in this condition. Participants will receive either CartiPRO or Synovian as an intra-articular injection at the start of the study and a second dose 24 weeks later. The study is randomized and single-blind, with assessments continuing through 36 weeks. Both treatments are given directly into the knee joint to evaluate their impact on pain and joint function. Participants will attend multiple visits for injections and assessments, including evaluations at 2, 4, 12, 24, and 36 weeks after the first injection. Researchers will measure changes in various pain scores, functional assessments like WOMAC and SF-36, and monitor safety through physical exams, vital signs, and lab tests. The primary outcome focuses on pain relief at 12 weeks, with ongoing monitoring to assess long-term effects and safety.
CONDITIONS
Brief 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 by American College of Rheumatology criteria, with at least 3 of these: age 50 or older, morning stiffness under 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 before screening
- Weight-bearing pain VAS score of 40 mm or higher in at least one knee at screening
- Able to walk without assistive devices, or if using a walking aid routinely for past 6 months, able to continue same use throughout study
- Able to understand and complete efficacy assessment questionnaires
- Willing and able to provide written informed consent
You will not qualify if you...
- Body Mass Index (BMI) greater than 32 kg/m2
- Chronic inflammatory joint diseases like rheumatoid arthritis
- Inflammatory joint diseases such as septic arthritis
- Secondary knee osteoarthritis due to conditions like ochronosis or hemochromatosis
- Painful musculoskeletal conditions affecting evaluation (e.g., Sudeck's atrophy, Paget's disease)
- Severe osteoarthritis in other joints that affect knee pain assessment
- Definite loss of patellofemoral joint space on X-ray
- Moderate to severe joint effusion confirmed by patellar tap test
- History of serious cardiac disease or uncontrolled high blood pressure despite treatment
- History of autoimmune disease
- Active infections needing intravenous antibiotics
- History of psychiatric disorders or epilepsy
- Cancer diagnosis within 5 years prior to screening
- Uncontrolled diabetes with HbA1c over 7%
- Knee surgery within 1 year or recent corticosteroid injections as specified
- Immunosuppressive therapy within 6 weeks
- Use of certain medications like anticoagulants or psychoactive drugs within specified time frames
- History or planned cell or gene therapy to target joint
- Abnormal lab values exceeding twice the upper normal limit
- High-intensity exercise affecting the knee
- Skin diseases or unsuitable injection sites
- Ligament instability grade II or higher
- Known allergy to study products
- Pregnancy or breastfeeding
- Unwillingness to use acceptable contraception if of childbearing potential
- Participation in another clinical trial within 4 weeks
- Cognitive impairment or dementia preventing consent
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive intra-articular injections of either CartiPRO or Synovian® at baseline and again at 24 weeks.
2 visits (in-person injections at baseline and Week 24) plus visits at Weeks 2, 4, and 12 after the first injection
Duration - 12 weeks
Participants are assessed for long-term efficacy and safety 12 weeks after the second injection.
1 visit (in-person) at Week 36
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
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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