Osteoarthritis, KneeNCT07052851
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
A study testing CCoat, Liposphere Ltd and Synvisc-One® (hylan G-F 20) in people with Osteoarthritis, Knee, run by Lipo-Sphere.
Trial summary
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- CCoat, Liposphere Ltd and Synvisc-One® (hylan G-F 20)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed and dated the informed consent form (ICF).
- Age ≥18 years.
- Participants must have a KOOS Pain subscale score of 25≤75 in the index knee over the last week before screening.
- Minimum baseline severity: At least two items in the KOOS Pain Subscale must be scored as moderate or worse (score 2-4 on the 0-4 scale).
- Pain consistency: Subjects must have experienced knee pain on most days in the past month to exclude acute or transient cases.
- Participants must have a KOOS Symptoms subscale score of 30≤ 75 in the index knee over the last week before screening. Subjects must report at least moderate severity (score ≥2) in at least one of the following:
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- Knee stiffness in the morning
- Knee stiffness after sitting/resting
- Swelling in the knee
- Degenerative changes in the index knee that can be categorized as grade II -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographs of the knee.
- Body Mass Index (BMI) between 18.5 kg/m2 and 38 kg/m2
- A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of CCoat.
- If female, the subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential using at least 2 methods of birth control that are effective from at least 30 days before Visit 1 through visit 26 w (26 weeks post injection).
- Are willing or able to comply with the procedures required in this protocol.
Who cannot join
- Osteoarthritis of the index knee graded 4 according to the Kellgren- Lawrence Grading.
- History of significant knee trauma or previous surgery of the intended study knee within the last 3 months preceding the screening.
- KOOS Pain subscale score of ≤25 or >75 in the index knee.
- Pain in the contra lateral knee: KOOS Pain subscale score of ≤75.
- Intra-articular injection to the intended study knee within 3 months before screening.
- Significant instability of the index knee.
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- Malalignment of more than 10 degrees varus OR 10 degrees valgus according to standing X-ray.
- Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study.
- History of Psoriatic Arthritis, Rheumatoid Arthritis, or any other inflammatory condition associated with arthritis.
- Wound in the area of the index knee.
- Any known tumor of the index knee.
- Any known history of intra-articular or osseous infection of the index knee.
- Any evidence of active infection anywhere in the body.
- Any known systemic cartilage and/or bone disorder, such as but not limited to, chondrodysplasia or osteogenesis imperfecta.
- Active malignancies, excluding BCC.
- Chemotherapy and/or radiation in the past 12 months.
- Known history of a severe allergic reactions.
- Patient who is pregnant or intends to become pregnant during the study.
- Breastfeeding female patients.
- History of any significant systemic disease, such as but not limited to: hepatitis and coagulopathies.
- Immunosuppressives, anti-coagulants.
- A known substance or alcohol abuse.
- Participation in other clinical trials within 60 days to before the study or concurrent with the study.
- Known insulin dependent diabetes mellitus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
Read the detailed description
The study aims to evaluate the performance of a single intra-articular injection of CCoat in patients with mild to moderate knee osteoarthritis over 26 weeks. Intra-articular injections are widely used for their localized efficacy and reduced systemic toxicity compared to oral treatments. Current treatments, including corticosteroids and hyaluronic acid, have limitations such as short-term effects and potential cartilage damage [1],[2],[3],[4]. Platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs) offer promise but require further validation [5],[6],[7]. CCoat, a liposomal boundary lubricant, provides a novel approach by coating cartilage surfaces to reduce wear, offering mechanical protection without altering synovial fluid properties.
CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from mild to moderate knee osteoarthritis (OA), developed by Liposphere LTD. CCoat is a liposomal boundary lubricant that coats the cartilage surface and temporarily protects it from further damage and degradation.
The performance and safety of CCoat device over 26 weeks is being evaluated in another multi-center, prospective, placebo controlled, randomized, double- blinded clinical study in 150 patients with mild to moderate OA of the knee (per study protocol # CLD0000616). As this study is ongoing, there is no currently available data related to the performance of the device. With regards to the CCoat's safety, in the interim analysis no safety concerns were raised.
This clinical investigation aims to further confirm the performance of CCoat when used as intended for the treatment of mild to moderate knee osteoarthritis (OA) in a larger patient population group, in comparison to a marketed hyaluronic acid product. This study is critical to further confirm the benefit-risk profile of the CCoat device as a valid therapeutic option for knee OA treatment, which remains a significant unmet medical need.
- Conditions
- Osteoarthritis, Knee
- Being tested
- CCoat, Liposphere Ltd, Synvisc-One® (hylan G-F 20)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCoat, Liposphere LtdDevice
a single IA injection of 4 ml CCoat
Synvisc-One® (hylan G-F 20)Device
Group 2 (Active Comparator): a single IA Synvisc-One® (hylan G-F 20) of 6 mL, Genzyme Corporation
| Study group | Role | What they receive |
|---|---|---|
| CCoat, Liposphere Ltd. | Experimental | CCoat is indicated for patients with mild to moderate OA of the knee. a single IA injection of 4 ml CCoat Receives: Device: CCoat, Liposphere Ltd |
| Synvisc-One® (hylan G-F 20), | Active comparator | intra-articular injection, 6 mL single-dose syringe, Genzyme Corporation Receives: Device: Synvisc-One® (hylan G-F 20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain score at 12 weeks
The change in KOOS Pain score from baseline to 12 weeks visit will be compared between the treatment groups using a repeated measures analysis of covariance (ANCOVA, SAS® MIXED procedure). The model will include the following fixed effects: treatment group, visit, treatment group by visit interaction with Baseline KOOS Pain, K/L grade, and center entered as covariates. The principal statistical analysis will be a comparison between the treatment groups, derived from the visit by treatment group interaction term from the model. The adjusted mean change from baseline in KOOS Pain scores at 12 weeks post treatment initiation will be estimated from the model (LS Means) interaction term for each group as well as the difference between the adjusted means and presented together with 95% Confidence Intervals (CI's).
Measured: Time Frame: Day 0, up to week 12
Secondary outcomes (1)
The secondary objective is to assess change from baseline to 2 and 12 weeks in KOOS Symptoms and ADL scores.
- Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms score at 12 weeks - [Time Frame: Day 0, up to week 12]
- Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) score at 12 weeks - [Time Frame: Day 0, up to week 12]
- Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) score at 12 weeks - [Time Frame: Day 0, up to week 12]
Measured: baseline to 2 and 12 weeks in KOOS Symptoms and ADL scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipo-Sphere
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052851
- Sponsor's protocol ID
- CLD0001465
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 7 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
- ClinicalTrials.gov ID
- NCT07052851
- Acronym / sponsor ID
- CLD0001465
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lipo-SphereIndustry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Jul 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.
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
Detailed description
The study aims to evaluate the performance of a single intra-articular injection of CCoat in patients with mild to moderate knee osteoarthritis over 26 weeks. Intra-articular injections are widely used for their localized efficacy and reduced systemic toxicity compared to oral treatments. Current treatments, including corticosteroids and hyaluronic acid, have limitations such as short-term effects and potential cartilage damage [1],[2],[3],[4]. Platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs) offer promise but require further validation [5],[6],[7]. CCoat, a liposomal boundary lubricant, provides a novel approach by coating cartilage surfaces to reduce wear, offering mechanical protection without altering synovial fluid properties.
CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from mild to moderate knee osteoarthritis (OA), developed by Liposphere LTD. CCoat is a liposomal boundary lubricant that coats the cartilage surface and temporarily protects it from further damage and degradation.
The performance and safety of CCoat device over 26 weeks is being evaluated in another multi-center, prospective, placebo controlled, randomized, double- blinded clinical study in 150 patients with mild to moderate OA of the knee (per study protocol # CLD0000616). As this study is ongoing, there is no currently available data related to the performance of the device. With regards to the CCoat's safety, in the interim analysis no safety concerns were raised.
This clinical investigation aims to further confirm the performance of CCoat when used as intended for the treatment of mild to moderate knee osteoarthritis (OA) in a larger patient population group, in comparison to a marketed hyaluronic acid product. This study is critical to further confirm the benefit-risk profile of the CCoat device as a valid therapeutic option for knee OA treatment, which remains a significant unmet medical need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCoat, Liposphere Ltd. | Experimental | Device: CCoat, Liposphere LtdCCoat is indicated for patients with mild to moderate OA of the knee. a single IA injection of 4 ml CCoat |
| Synvisc-One® (hylan G-F 20), | Active comparator | Device: Synvisc-One® (hylan G-F 20)intra-articular injection, 6 mL single-dose syringe, Genzyme Corporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject has signed and dated the informed consent form (ICF).
- Age ≥18 years.
- Participants must have a KOOS Pain subscale score of 25≤75 in the index knee over the last week before screening.
- Participants must have a KOOS Symptoms subscale score of 30≤ 75 in the index knee over the last week before screening. Subjects must report at least moderate severity (score ≥2) in at least one of the following:
- Degenerative changes in the index knee that can be categorized as grade II -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographs of the knee.
Key exclusion criteria (24 listed)
- Osteoarthritis of the index knee graded 4 according to the Kellgren- Lawrence Grading.
- History of significant knee trauma or previous surgery of the intended study knee within the last 3 months preceding the screening.
- KOOS Pain subscale score of ≤25 or >75 in the index knee.
- Pain in the contra lateral knee: KOOS Pain subscale score of ≤75.
- Intra-articular injection to the intended study knee within 3 months before screening.
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 |
|---|---|---|
| CCoat, Liposphere Ltda single IA injection of 4 ml CCoat | Device | CCoat, Liposphere Ltd. |
| Synvisc-One® (hylan G-F 20)Group 2 (Active Comparator): a single IA Synvisc-One® (hylan G-F 20) of 6 mL, Genzyme Corporation | Device | Synvisc-One® (hylan G-F 20), |
Primary outcome
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain score at 12 weeks
Time frame: Time Frame: Day 0, up to week 12
The change in KOOS Pain score from baseline to 12 weeks visit will be compared between the treatment groups using a repeated measures analysis of covariance (ANCOVA, SAS® MIXED procedure). The model will include the following fixed effects: treatment group, visit, treatment group by visit interaction with Baseline KOOS Pain, K/L grade, and center entered as covariates. The principal statistical analysis will be a comparison between the treatment groups, derived from the visit by treatment group interaction term from the model. The adjusted mean change from baseline in KOOS Pain scores at 12 weeks post treatment initiation will be estimated from the model (LS Means) interaction term for each group as well as the difference between the adjusted means and presented together with 95% Confidence Intervals (CI's).
1 secondary outcome
The secondary objective is to assess change from baseline to 2 and 12 weeks in KOOS Symptoms and ADL scores.
Time frame: baseline to 2 and 12 weeks in KOOS Symptoms and ADL scores.
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 7 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CCoat, Liposphere Ltd and Synvisc-One® (hylan G-F 20) in people with Osteoarthritis, Knee, run by Lipo-Sphere.
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 14 inclusion and 24 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: opening soon, as of the sponsor's last update on 7 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Arielle Grinberg Ismach (+972584005218, arielle.grinberg.is@lipo-sphere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain score at 12 weeks (time frame: Time Frame: Day 0, up to week 12). 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 7 Jul 2025.