OsteoarthitisNCT07511777
Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis
A study testing CartiZol and Synovian inj. in people with Osteoarthitis, run by Cellontech Co., Ltd. at 1 site in South Korea.
Trial summary
This study was designed to assess the efficacy for pain relief, functional improvement, and safety of intra-articular collagen injections compared to hyaluronic acid injections for knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthitis
- What is being tested?
- CartiZol and Synovian inj.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Feb 2024to 13 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 19 years or older
- Patients with knee pain due to osteoarthritis (OA)
- Patients with Kellgren-Lawrence grade 3 or less
- Patients with a 100 mm VAS pain level of 40 mm or greater
- Patients without clinically significant clinical pathology test results during the screening period
- Patients who confirmed accurate prescription records for medications taken within at least one week before the study and agree to maintain the same dosage of concomitant medications as before the injection if such medications are continuously administered during the study period
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- If taking concomitant medications, patients who have been on stable medication for approximately two weeks before participating in the study, considering the duration of drug maintenance in the body (stability must be confirmed one week before screening and reconfirmed at the time of registration when the injection is applied to ensure two weeks of stable medication use)
- Rescue analgesic medications administered within one week of intra-articular injection are allowed (given to the subject after injection), provided that if additional analgesics are required due to increased pain at the observation site, patients should agree not to use more than 5 consecutive days or 10 days per month, and to stop taking analgesics at least 2 days before the next visit.
- Patients who agree to undergo only non-drug therapies (physical therapy, osteopathy, chiropractic care) as allowed by a clinician (excluding acupuncture)
- Patients who agree to have the injection administered to the more painful knee if both knees are affected (intra-articular injections in the contralateral knee are prohibited)
- Patients or their legal representatives who consent to participate in the study and sign the written informed consent form
Who cannot join
- Patients with ongoing or past autoimmune diseases, either personally or in their family
- Patients with a history of anaphylactic reactions
- Patients with hypersensitivity to implants
- Patients with hypersensitivity to porcine protein
- Patients with a Kellgren-Lawrence grade of 4
- Patients with severe effusion
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- Patients who had a serious injury or received an injection in the affected knee that may interfere with evaluation within 6 months prior to screening
- Patients with inflammatory arthritis, such as rheumatoid arthritis, lupus arthritis, or psoriatic arthritis (except when deemed eligible for collagen administration by the clinician)
- Patients with gout or pseudogout diagnosed within 6 months prior to screening (except when deemed eligible for collagen administration by the clinician)
- Patients with a history of radiation or chemotherapy within the past 2 years (except when deemed eligible for collagen administration by the clinician)
- Diabetic patients (except those who maintain normal blood sugar levels, have no complications related to diabetes, and are deemed eligible for collagen administration by the clinician)
- Patients with infections receiving treatment with antibiotics or antimicrobials that require hospitalization (except when deemed eligible for collagen administration by the clinician)
- Patients receiving adrenocortical hormone therapy (except when deemed eligible for collagen administration by the clinician)
- Patients with heart, liver, or kidney diseases (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed; hypertension excluded)
- Patients with viral infections (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed)
- Patients with any clinically significant medical condition that may affect the completion of the study
- Patients who are pregnant, breastfeeding, or planning to become pregnant
- Patients with mental illness or others deemed inappropriate for the study by the study staff
- Patients scheduled for surgery during the study period
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Double Blind, Randomized Post Marketing Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis
This study was designed to assess the efficacy for pain relief, functional improvement, and safety of intra-articular collagen injections compared to hyaluronic acid injections for knee osteoarthritis.
Read the detailed description
This is a double-blind study involving 100 participants. After receiving an explanation of the study and voluntarily providing written informed consent, subjects underwent a screening process to confirm eligibility. Eligible subjects were randomly assigned to receive an intra-articular injection of either collagen or hyaluronic acid. To maintain the double-blind design, the intra-articular injection was administered by a separate unblinded injector. During the study period, subjects were required to follow the investigator's instructions. According to the study protocol, subjects participated in the study for 12 months from enrollment. A total of six hospital visits were conducted, including a screening visit, an enrollment/injection visit, visits at 4 and 12 weeks after injection, and follow-up visits at 24 and 52 weeks. At each visit, efficacy was evaluated according to the clinical trial protocol through questionnaire assessments and blood tests, and safety was assessed by monitoring adverse events.
- Conditions
- Osteoarthitis
- Being tested
- CartiZol, Synovian inj.
- Keywords
- intra-articular injection, intra-articular collagen injection, collagen, knee joint pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartiZolDevice
Also called Intra-articular collagen injection
The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage.
Synovian inj.Drug
Also called Intra-articular hyaluronic acid injection
A hyaluronic acid gel-type intra-articular injection, Synovian inj., facilitates joint lubrication and helps protect cartilage, thereby alleviating pain associated with knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| CartiZol | Experimental | Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. Receives: Device: CartiZol |
| Synovian inj. (Hyaluronic acid) | Active comparator | Their eligibility to participate in the study is checked, and they are randomized into the intra-articular hyaluronic acid injection group based on a randomization table. Receives: Drug: Synovian inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) for Pain (0-100 mm)
- Efficacy Evaluation Analysis The change in the VAS score of the affected knee between screening and 12 weeks post-injection will be compared between the test group and the control group.
- Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups.
Scale description: 0 = no pain, 100 = worst imaginable pain (higher scores indicate worse pain)
Measured: From screening to 12, 24, and 52 weeks post-injection
Secondary outcomes (7)
Visual Analogue Scale (VAS) for Pain (0-100 mm)
- Efficacy Evaluation Analysis The change in the VAS score of the affected knee between screening and 4 weeks post-injection will be compared between the test group and the control group. The VAS score of the affected knee at 4 weeks post-injection will be compared between the test group and the control group. The intra-group change in the VAS score of the affected knee between screening and 4 weeks post-injection will be compared for each group.
- Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups.
Scale description: 0 = no pain, 100 = worst imaginable pain (higher scores indicate worse pain)
Measured: From screening to 4, 12, 24, and 52 weeks post-injection
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
- Efficacy Evaluation Analysis The change in the WOMAC score of the affected knee between screening and 4 and 12 weeks post-injection will be compared between the test group and the control group. The WOMAC score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group. The intra-group change in the WOMAC score of the affected knee between screening and 4 and 12 weeks post-injection will be compared for each group.
- Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups.
Scale range: 0-96 (higher scores indicate worse pain, stiffness, and physical dysfunction)
Measured: From screening to 4, 12, 24, and 52 weeks post-injection
Short Form-36 Health Survey (SF-36)
- Efficacy Evaluation Analysis The change in the SF-36 score of the affected knee between screening and 4 and 12 weeks post-injection will be compared between the test group and the control group. The SF-36 score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group. The intra-group change in the SF-36 score of the affected knee between screening and 4 and 12 weeks post-injection will be compared for each group.
- Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups.
Scale range: 0-100 (higher scores indicate better health-related quality of life)
Measured: From screening to 4, 12, 24, and 52 weeks post-injection
Participant satisfaction
- Efficacy Evaluation Analysis The score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group.
- Safety Evaluation Analysis The evaluation values at 24 and 52 weeks post-injection will be compared between the test group and the control group.
Scale description:
Participants rated their overall satisfaction regarding pain relief and functional improvement compared to pre-injection status using a 5-point scale:
4 = Markedly improved 3 = Slightly improved 2 = No change
1 = Slightly worsened 0 = Markedly worsened (higher scores indicate greater improvement)
Measured: At 4, 12, 24, and 52 weeks post-injection
Investigator satisfaction
- Efficacy Evaluation Analysis The score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group.
- Safety Evaluation Analysis The evaluation values at 24 and 52 weeks post-injection will be compared between the test group and the control group.
Investigators rated the overall improvement in pain and functional status of the affected knee compared to the pre-injection condition using a 5-point scale:
4 = Markedly improved 3 = Slightly improved 2 = No change
1 = Slightly worsened 0 = Markedly worsened compared to pre-injection (higher scores indicate greater improvement)
Measured: At 4, 12, 24, and 52 weeks post-injection
X-ray examination (Kellgren-Lawrence Grade 1-4)
- Efficacy Evaluation Analysis The score of the affected knee at 12 weeks post-injection will be compared between the test group and the control group.
- Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups.
Scale description: Grade 1-4 (higher grades indicate more severe osteoarthritis)
Measured: At 12, 24, and 52 weeks post-injection
Biomarker test
- Efficacy Evaluation Analysis The change in the test values between screening and 12 weeks post-injection will be compared between the test group and the control group. The test values at 12 weeks post-injection will be compared between the test group and the control group.
- Follow-up Evaluation Analysis The changes from baseline to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups.
Scale description: Continuous laboratory values (units vary by parameter; higher values may indicate abnormal findings depending on the parameter) Parameters include hematologic and serum biochemical tests such as WBC, RBC, hemoglobin(Hb), hematocrit(Hct), platelets(PLT), differential counts, erythrocyte sedimentation rate(ESR), blood urea nitrogen(BUN), creatinine, C-reactive protein(CRP), aspartate aminotransferase(AST), and alanine aminotransferase(ALT).
Measured: From screening to 12, 24, and 52 weeks post-injection, and at 12, 24, and 52 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start6 Feb 2024
- Primary completion5 Aug 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong In, MD, Principal investigator, The Catholic University of KoreaMan-Soo Kim, MD, Principal investigator, The Catholic University of KoreaGeun-Yooung Choi, MD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511777
- Sponsor's protocol ID
- 02CTZ
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized Post Marketing Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07511777
- Acronym / sponsor ID
- 02CTZ
- Conditions
- Osteoarthitis
- Keywords
- intra-articular injection, intra-articular collagen injection, collagen, knee joint pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 6 Apr 2026 (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 study was designed to assess the efficacy for pain relief, functional improvement, and safety of intra-articular collagen injections compared to hyaluronic acid injections for knee osteoarthritis.
Detailed description
This is a double-blind study involving 100 participants. After receiving an explanation of the study and voluntarily providing written informed consent, subjects underwent a screening process to confirm eligibility. Eligible subjects were randomly assigned to receive an intra-articular injection of either collagen or hyaluronic acid. To maintain the double-blind design, the intra-articular injection was administered by a separate unblinded injector. During the study period, subjects were required to follow the investigator's instructions. According to the study protocol, subjects participated in the study for 12 months from enrollment. A total of six hospital visits were conducted, including a screening visit, an enrollment/injection visit, visits at 4 and 12 weeks after injection, and follow-up visits at 24 and 52 weeks. At each visit, efficacy was evaluated according to the clinical trial protocol through questionnaire assessments and blood tests, and safety was assessed by monitoring adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CartiZol | Experimental | Device: CartiZolTheir eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. |
| Synovian inj. (Hyaluronic acid) | Active comparator | Drug: Synovian inj.Their eligibility to participate in the study is checked, and they are randomized into the intra-articular hyaluronic acid injection group based on a randomization table. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged 19 years or older
- Patients with knee pain due to osteoarthritis (OA)
- Patients with Kellgren-Lawrence grade 3 or less
- Patients with a 100 mm VAS pain level of 40 mm or greater
- Patients without clinically significant clinical pathology test results during the screening period
Key exclusion criteria (19 listed)
- Patients with ongoing or past autoimmune diseases, either personally or in their family
- Patients with a history of anaphylactic reactions
- Patients with hypersensitivity to implants
- Patients with hypersensitivity to porcine protein
- Patients with a Kellgren-Lawrence grade of 4
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 |
|---|---|---|
| CartiZolAlso: Intra-articular collagen injectionThe product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. | Device | CartiZol |
| Synovian inj.Also: Intra-articular hyaluronic acid injectionA hyaluronic acid gel-type intra-articular injection, Synovian inj., facilitates joint lubrication and helps protect cartilage, thereby alleviating pain associated with knee osteoarthritis. | Drug | Synovian inj. (Hyaluronic acid) |
Primary outcome
Visual Analogue Scale (VAS) for Pain (0-100 mm)
Time frame: From screening to 12, 24, and 52 weeks post-injection
1. Efficacy Evaluation Analysis The change in the VAS score of the affected knee between screening and 12 weeks post-injection will be compared between the test group and the control group. 2. Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups. Scale description: 0 = no pain, 100 = worst imaginable pain (higher scores indicate worse pain)
7 secondary outcomes
Visual Analogue Scale (VAS) for Pain (0-100 mm)
Time frame: From screening to 4, 12, 24, and 52 weeks post-injection
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: From screening to 4, 12, 24, and 52 weeks post-injection
Short Form-36 Health Survey (SF-36)
Time frame: From screening to 4, 12, 24, and 52 weeks post-injection
Participant satisfaction
Time frame: At 4, 12, 24, and 52 weeks post-injection
Investigator satisfaction
Time frame: At 4, 12, 24, and 52 weeks post-injection
X-ray examination (Kellgren-Lawrence Grade 1-4)
Time frame: At 12, 24, and 52 weeks post-injection
Biomarker test
Time frame: From screening to 12, 24, and 52 weeks post-injection, and at 12, 24, and 52 weeks post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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, MD principal investigator
The Catholic University of Korea
Man-Soo Kim, MD principal investigator
The Catholic University of Korea
Geun-Yooung Choi, MD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CartiZol and Synovian inj. in people with Osteoarthitis, run by Cellontech Co., Ltd. at 1 site 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 11 inclusion and 19 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (VAS) for Pain (0-100 mm) (time frame: From screening to 12, 24, and 52 weeks post-injection). 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 13 Apr 2026.