Status:
COMPLETED
Intra-Articular Injection in Moderate Knee Osteoarthritis
Lead Sponsor:
Lipo-Sphere
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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, whic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05412836
Start Date
March 22 2022
End Date
January 30 2023
Last Update
March 7 2023
Active Locations (1)
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1
Assuta
Ashdod, Israel