OsteoarthritisNCT07267793
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
A study testing CartiPRO and Synovian® in people with Osteoarthritis and Knee Pain Arthritis, run by DALIM TISSEN Co., Ltd. at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Knee Pain Arthritis, Cartilage Defects of the Knee
- What is being tested?
- CartiPRO and Synovian®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 3 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 36Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, 13620
CHA Bundang Medical Center
Seoul, Bundang-gu, 13496
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 03312
Gachon University Gil Hospital
Seoul, Namdong-gu, 21565
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Seochogu, 06591
About this study
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
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.
Read the detailed description
Knee osteoarthritis (OA) is the most common joint disorder, primarily caused by the destruction of articular cartilage. Symptoms typically include joint pain, stiffness, and muscle contraction. According to the World Health Organization, in 2013, an estimated 10-15% of adults over the age of 60 were affected by OA, significantly impacting their quality of life.
Collagen degradation is a key feature of cartilage damage in OA. Collagen-based injectable materials, such as atelocollagen, are being explored as potential therapeutic options to restore collagen and improve clinical outcomes. Unlike other injectable substances like hyaluronic acid or corticosteroids, collagen's stable triple helix structure and long half-life make it more resistant to enzymatic degradation, offering a potentially longer-lasting effect.
Despite this, long-term and repeated use data for atelocollagen injections in knee OA are limited both domestically and internationally. This study aims to provide robust clinical evidence on the efficacy and safety of repeated intra-articular atelocollagen injections for knee pain relief in patients with knee OA.
This is a randomized, single-blind, active-controlled study comparing CartiPRO with Synovian. Subjects with knee OA and symptomatic knee pain will receive the investigational device intra-articularly. A second dose will be administered at 24 weeks. The primary outcome is the change in 100-mm weight-bearing pain (WBP) VAS score at 12 weeks compared to baseline.
Secondary outcomes include VAS changes in WBP, resting pain (RP), motion pain (MP), and night pain (NP) at multiple time points, as well as changes in WOMAC and SF-36 scores. Long-term efficacy will be assessed after re-injection. Safety assessments include adverse events, local reactions, physical examination, vital signs, and laboratory tests.
Study Visits:
Visit 1: Screening Visit 2: First injection (baseline) Visit 3: 2 weeks after injection Visit 4: 4 weeks after injection Visit 5: 12 weeks after injection Visit 6: 24 weeks after injection (second dose) Visit 7: 36 weeks after first injection
- Conditions
- Osteoarthritis, Knee Pain Arthritis, Cartilage Defects of the Knee, Knee Osteoarthritis, Degenerative Joint Disease of Knee
- Being tested
- CartiPRO, Synovian®
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartiPRODevice
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.
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 | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Group applied with CartiPRO Receives: Device: CartiPRO |
| Control group | Active comparator | Group applied with Synovian® Receives: Drug: Synovian® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week 12 after the first administration
Secondary outcomes (12)
Change from Baseline in Weight-Bearing Pain Visual Analogue Scale 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.
Measured: 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
The change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index will be assessed for the pain, stiffness, and physical function subscales, as well as the total score. Each item is rated from 0 to 4, where 0 indicates no symptoms and 4 indicates extreme symptoms. Subscale scores are calculated by summing item scores, and the total score is calculated as the sum of the subscale scores. Higher scores indicate worse symptoms and poorer function.
Measured: 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)
The change from baseline in the 36-Item Short Form Health Survey (SF-36) will be assessed using the eight domain scores: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain score ranges from 0 to 100, where higher scores indicate better health status/quality of life.
Measured: at Weeks 2, 4, 12, and 24 after the first administration
Change from Baseline in Rest Pain Visual Analogue Scale Score (0-100 mm)
The change from baseline in Rest 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 worse pain.
Measured: at Weeks 2, 4, 12, and 24 after the first administration
Change from Baseline in Motion Pain Visual Analogue Scale Score (0-100 mm)
The change from baseline in Motion 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.
Measured: at Weeks 2, 4, 12, and 24 after the first administration
Change from Baseline in Night Pain Visual Analogue Scale Score (0-100 mm)
The change from baseline in Night 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.
Measured: at Weeks 2, 4, 12, and 24 after the first administration
Change from Week 24 (Re-administration) in Weight-Bearing Pain Visual Analogue Scale Score (0-100 mm)
The change from Week 24, defined as the time of re-administration, 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 worse pain.
Measured: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Rest Pain Visual Analogue Scale Score (0-100 mm)
The change from Week 24, defined as the time of re-administration, in Rest 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 worse pain.
Measured: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Motion Pain Visual Analogue Scale Score (0-100 mm)
The change from Week 24, defined as the time of re-administration, in Motion 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.
Measured: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Night Pain Visual Analogue Scale Score (0-100 mm)
The change from Week 24, defined as the time of re-administration, in Night 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.
Measured: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Western Ontario and McMaster Universities Osteoarthritis Index Total and Subscale Scores
The change from Week 24, defined as the time of re-administration, in the Western Ontario and McMaster Universities Osteoarthritis Index will be assessed for the pain, stiffness, and physical function subscales, as well as the total score. Each item is rated from 0 to 4, where 0 indicates no symptoms and 4 indicates extreme symptoms. Subscale scores are calculated by summing item scores, and the total score is calculated as the sum of the subscale scores. Higher scores indicate worse symptoms and poorer function.
Measured: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in 36-Item Short Form Health Survey Domain Scores (SF-36)
The change from Week 24, defined as the time of re-administration, in the 36-Item Short Form Health Survey (SF-36) will be assessed using the eight domain scores: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain score ranges from 0 to 100. Higher scores indicate better health status/quality of life.
Measured: at Week 36 (12 weeks after re-administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start3 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DALIM TISSEN Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong In, Ph.D, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267793
- Sponsor's protocol ID
- DLTS_05
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided. The plan for sharing individual participant data has not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07267793
- Acronym / sponsor ID
- DLTS_05
- Conditions
- Osteoarthritis, Knee Pain Arthritis, Cartilage Defects of the Knee, Knee Osteoarthritis, Degenerative Joint Disease of Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- DALIM TISSEN Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Knee osteoarthritis (OA) is the most common joint disorder, primarily caused by the destruction of articular cartilage. Symptoms typically include joint pain, stiffness, and muscle contraction. According to the World Health Organization, in 2013, an estimated 10-15% of adults over the age of 60 were affected by OA, significantly impacting their quality of life.
Collagen degradation is a key feature of cartilage damage in OA. Collagen-based injectable materials, such as atelocollagen, are being explored as potential therapeutic options to restore collagen and improve clinical outcomes. Unlike other injectable substances like hyaluronic acid or corticosteroids, collagen's stable triple helix structure and long half-life make it more resistant to enzymatic degradation, offering a potentially longer-lasting effect.
Despite this, long-term and repeated use data for atelocollagen injections in knee OA are limited both domestically and internationally. This study aims to provide robust clinical evidence on the efficacy and safety of repeated intra-articular atelocollagen injections for knee pain relief in patients with knee OA.
This is a randomized, single-blind, active-controlled study comparing CartiPRO with Synovian. Subjects with knee OA and symptomatic knee pain will receive the investigational device intra-articularly. A second dose will be administered at 24 weeks. The primary outcome is the change in 100-mm weight-bearing pain (WBP) VAS score at 12 weeks compared to baseline.
Secondary outcomes include VAS changes in WBP, resting pain (RP), motion pain (MP), and night pain (NP) at multiple time points, as well as changes in WOMAC and SF-36 scores. Long-term efficacy will be assessed after re-injection. Safety assessments include adverse events, local reactions, physical examination, vital signs, and laboratory tests.
Study Visits:
Visit 1: Screening Visit 2: First injection (baseline) Visit 3: 2 weeks after injection Visit 4: 4 weeks after injection Visit 5: 12 weeks after injection Visit 6: 24 weeks after injection (second dose) Visit 7: 36 weeks after first injection
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: CartiPROGroup applied with CartiPRO |
| Control group | Active comparator | Drug: Synovian®Group applied with Synovian® |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (36 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CartiPROClinical 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. | Device | Study Group |
| Synovian®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. | Drug | Control group |
Primary outcome
Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm)
Time frame: at week 12 after the first administration
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.
12 secondary outcomes
Change from Baseline in Weight-Bearing Pain Visual Analogue Scale Score (0-100 mm)
Time frame: 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
Time frame: 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)
Time frame: at Weeks 2, 4, 12, and 24 after the first administration
Change from Baseline in Rest Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Weeks 2, 4, 12, and 24 after the first administration
Change from Baseline in Motion Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Weeks 2, 4, 12, and 24 after the first administration
Change from Baseline in Night Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Weeks 2, 4, 12, and 24 after the first administration
Change from Week 24 (Re-administration) in Weight-Bearing Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Rest Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Motion Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Night Pain Visual Analogue Scale Score (0-100 mm)
Time frame: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in Western Ontario and McMaster Universities Osteoarthritis Index Total and Subscale Scores
Time frame: at Week 36 (12 weeks after re-administration)
Change from Week 24 (Re-administration) in 36-Item Short Form Health Survey Domain Scores (SF-36)
Time frame: at Week 36 (12 weeks after re-administration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. Undecided. The plan for sharing individual participant data has not yet been determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong In, Ph.D principal investigator
The Catholic University of Korea
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CartiPRO and Synovian® in people with Osteoarthritis and Knee Pain Arthritis, run by DALIM TISSEN Co., Ltd. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm) (time frame: at week 12 after the first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.