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

NCT ID
NCT07267793
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
DALIM TISSEN Co., Ltd.
Conditions
Cartilage Defects of the Knee, Degenerative Joint Disease of Knee, Knee Osteoarthritis, Knee Pain Arthritis, Osteoarthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 194 participants (Estimated).

What is being studied

  • Device: CartiPRO
  • Drug: Synovian®

Who may be eligible

Ages
19 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility 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

Study locations

5 study locations are listed.

Recruiting site status is explicitly provided for 5 locations; 5 are listed as Recruiting.

Countries: South Korea

  • Bundang-gu, South Korea: 2
  • Eunpyeong-gu, South Korea: 1
  • Namdong-gu, South Korea: 1
  • Seochogu, South Korea: 1

Sample of listed locations

  • 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

Study details

Start date
July 3, 2025
Primary completion date
December 1, 2026
Completion date
June 1, 2027
First posted
December 5, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07267793
Registry last updated
September 17, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07267793 on ClinicalTrials.gov

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