Long-term CartiPRO treatment for knee pain from osteoarthritis or cartilage damage
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, Sponsor Initiated Trial
This study will test whether two CartiPRO knee injections, given 24 weeks apart, relieve pain better than Synovian in adults with knee osteoarthritis or cartilage damage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | DALIM TISSEN Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Seongnam-si, Bundang-gu and 4 other locations) |
| Trial ID | NCT07267793 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind, active-controlled trial compares intra-articular CartiPRO (atelocollagen) with Synovian in adults who have symptomatic knee osteoarthritis or cartilage defects. Participants receive an initial injection and a second dose at 24 weeks, with follow-up through 36 weeks to monitor outcomes. Primary and secondary measures include weight-bearing pain VAS, WOMAC and SF-36 functional scores, and safety assessments. Eligible patients must have Kellgren–Lawrence grade I–III disease and a baseline weight-bearing VAS ≥40 mm.
Who should consider this trial
Good fit: Adults aged 19 and older with symptomatic knee osteoarthritis or cartilage damage, radiographic KL grade I–III, and a weight-bearing pain VAS ≥40 mm who can attend follow-up and complete questionnaires are ideal candidates.
Not a fit: Patients with very advanced OA (KL IV), chronic inflammatory joint disease, a BMI ≥32 kg/m², or other exclusion criteria are unlikely to benefit or may be ineligible for this protocol.
Why it matters
Potential benefit: If successful, repeated CartiPRO injections could provide longer-lasting pain relief and improved knee function compared with currently used intra-articular injections.
How similar studies have performed: Atelocollagen injections have shown promise in shorter-term studies and have some approvals for intra-articular use, but long-term and repeated-use evidence is limited internationally.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Exclusion Criteria * 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%) * Surgical procedures (including arthroscopy) on target knee within 1 year (surgery on contralateral knee or hip may be exclusionary if it could affect target knee assessment) * Intra-articular corticosteroid injection into target knee within 12 weeks * Systemic corticosteroid use within 4 weeks (topical and inhaled corticosteroids permitted) * Surgery or radiation therapy to knee joint within 12 weeks, or not fully recovered from side effects * Immunosuppressive therapy (e.g., Cyclosporine A, Azathioprine) within 6 weeks * Intra-articular injections (e.g., hyaluronic acid) into knee joint within 6 months * Prohibited concomitant medications within 2 weeks (unless washout period is adequate) * Anticoagulants (e.g., warfarin, NOACs), antiplatelet agents (e.g., aspirin \>100 mg/day, clopidogrel; low-dose aspirin ≤100 mg/day permitted), thrombolytic agents (e.g., urokinase, alteplase), or Vitamin E \>1000 IU/day within 2 weeks (unless adequate washout) * Habitual use (≥3 months) of psychoactive drugs or narcotic analgesics that may affect pain perception * History of cell therapy or gene therapy to target joint * Planned cell therapy or gene therapy to target joint * Abnormal laboratory values at screening: * ALT, AST, BUN, or serum creatinine \>2× upper limit of normal * Engaged in high-intensity aerobic or heavy anaerobic exercise that may affect the knee joint * Dermatological disease at injection site or site deemed unsuitable for injection * Ligament instability of Grade II or higher in target knee (Grade 0: none; Grade I: 0-5 mm; Grade II: 5-10 mm; Grade III: \>10 mm) * Known hypersensitivity to investigational product or its components * Pregnant or breastfeeding women * Women or men of childbearing potential unwilling to use acceptable contraception during study (acceptable methods: intrauterine device, tubal ligation, sterilization surgery, condom or diaphragm with spermicide, natural family planning) * Participation in another clinical trial within 4 weeks * Cognitive impairment or dementia preventing informed consent * Any other condition that makes the subject unsuitable for study participation per investigator judgment
Where this trial is running
Seongnam-si, Bundang-gu and 4 other locations
- Seoul National University Bundang Hospital — Seongnam-si, Bundang-gu, South Korea (Recruiting)
- CHA Bundang Medical Center — Seoul, Bundang-gu, South Korea (Recruiting)
- The Catholic University of Korea Eunpyeong St. Mary's Hospital — Seoul, Eunpyeong-gu, South Korea (Recruiting)
- Gachon University Gil Hospital — Seoul, Namdong-gu, South Korea (Recruiting)
- The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, Seochogu, South Korea (Recruiting)
Study contacts
- Principal investigator: Yong In, Ph.D — The Catholic University of Korea
- Study coordinator: Hyunjin Bae Dream CIS
- Email: su-bin.lee@tigermedgrp.com
- Phone: +82 2 2010 450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.