Not Yet RecruitingNot Applicable

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

200 participantsStarted 2025-07

Plain-language summary

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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).

✕. 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.

Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain score at 12 weeks

Timeframe: Time Frame: Day 0, up to week 12

NCT IDNCT07052851

SponsorLipo-Sphere

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Arielle Grinberg Ismach

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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).

✕. 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.