Intra-Articular Injection in Moderate Knee Osteoarthritis

Lipo-Sphere

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: AqueousJoint

Study type

Interventional

Funder types

Industry

Identifiers

NCT05412836

CJO-01

Details and patient eligibility

About

AqueousJoint is a new intra-articular (IA) injectable joint lubricant for patients suffering from knee Osteoarthritis developed by Liposphere LTD.

AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation. The product goal is restoring cartilage its natural bio-lubrication properties.

AqueousJoint is a surface lubricant that does not change the synovial fluid mechanical characterization but provides hydration protection from cartilage degradation and wear.

Enrollment

20 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Adult male or female at age ≥40 and ≤ 80 years old
Pain in the intended study knee with an average VAS score of >5 over the last week prior to visit 1 (pre-injection).
Degenerative changes in the intended study knee that can be categorized as grade II-IV Kellgren Lawrence based upon standing posterior-anterior and lateral radiographs of the knee based on X-RAY from up to the last 6 months prior visit 1 (pre-injection).
Body Mass Index (BMI) between 18.5 and 35.
A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of AqueousJoint.
If female, 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 26w (26 weeks post injection).
Are willing or able to comply with procedures required in this protocol.

Exclusion criteria

History of significant knee trauma or previous arthroscopic surgery of the intended study knee within the last 3 months preceding screening.
Concomitant moderate or large size synovial fluid effusion of the index knee at Screening
Wound in the area of the intended study knee
Fever signs or symptoms of systemic infection or infection of the intended study knee, on the day before or the day of administration of treatment.
Intra-articular injection to the intended study knee within 3 months prior to Screening.
Intra-articular injection was administrated during the past 6 weeks
Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study
Pain in any other joints with an average VAS score (active) of >4 at the time of Visit 1.
History of Psoriatic Arthritis, Rheumatoid Arthritis or any other inflammatory condition associated with arthritis
Known history of a severe allergic reaction
Known Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), Known Hepatitis B or C viral
history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the last 6 months that, in the Investigator's opinion, would adversely affect the subject's participation in the study.
History of cellulitis of the lower extremities, a peripheral vascular disease.
History of malignancies during the pat 3 years
Life expectancy of less than 12 month
Surgery involving the chest, abdomen, pelvis, or lower extremities in the past year
Participate in other clinical trials within 3 months prior to the study or concurrent with the study