Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial

NCT07052851 | Not Yet Recruiting

• 1 other identifier: CLD0001465
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  baseline to 2 and 12 weeks in KOOS Symptoms and ADL scores.

Study Arms (2)

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

Device: CCoat, Liposphere Ltd

Synvisc-One® (hylan G-F 20),

ACTIVE COMPARATOR

intra-articular injection, 6 mL single-dose syringe, Genzyme Corporation

Device: Synvisc-One® (hylan G-F 20)

Interventions

CCoat, Liposphere Ltd DEVICE

a single IA injection of 4 ml CCoat

CCoat, Liposphere Ltd.

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

Synvisc-One® (hylan G-F 20),

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lipo-Sphere: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Arielle Grinberg Ismach

CONTACT

+972584005218; arielle.grinberg.is@lipo-sphere.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant, Investigator and sponsor are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 7, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 7, 2025

Record last verified: 2025-06