Intra-Articular Injection in Moderate Knee Osteoarthritis

NCT05412836 | Completed

• 1 other identifier: CJO-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Adverse Events will be evaluated in order to assess the safety of intra-articular injection of Aqueous Joint in osteoarthritic patients up to 26 weeks of follow-up in an open-label clinical study.

  The safety parameters will include adverse reactions related to the injected material; injection-related side effects consisted of injection-site reaction, erythema, swelling, injection-site pain, and pruritus.

  26 weeks

Secondary Outcomes (4)

• Change in range of motion from visit 1 (pre-injection) to week 26

  26 weeks

• Change in life quality from visit 1 (pre-injection) to week 26

  26 weeks

• Change in functionality from visit 1 (pre-injection) to week 26

  26 weeks

• Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26

  26 weeks

Study Arms (1)

One Treatment Arm

EXPERIMENTAL

Subjects will receive a single intra-articular injection of AqueousJoint.

Device: AqueousJoint

Interventions

AqueousJoint DEVICE

AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.

One Treatment Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lipo-Sphere: lead

Study Sites (1)

Assuta

Ashdod, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: June 9, 2022
• Study Start: March 22, 2022
• Primary Completion: December 18, 2022
• Study Completion: January 30, 2023
• Last Updated: March 7, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)