Evaluation of Intra-articular Injection of Autologous Protein Solution (APS(TM)) for the Treatment of Osteoarthritis (OA)

Study Overview
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Brief Summary
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This prospective single-center study will evaluate the safety and tolerability of a single dose of APS(TM) treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.

Official Title
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A Prospective Single-Center Clinical Study of a Single Intra-Articular Injection of Autologous Protein Solution (APS(TM)) in Patients With Osteoarthritis (OA) of the Knee

Conditions
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Gonarthrosis, Knee Osteoarthritis, Osteoarthritis

Intervention / Treatment
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* Device: Autologous Protein Solution APS(TM)


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria: Male or female ≥40 years. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. A standing radiograph of the knee showing a Kellgren grade of 2 or 3 Frequency of knee pain on most days over the last month. Diagnosis of unilateral knee OA Body mass index (BMI) ≤40 kg/m2. Failed conservative OA therapy. Signed an independent ethics committee (IEC)-approved informed consent form (ICF). Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study. Willingness to abstain from systemic pain medications except rescue medication.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Protein Solution APS(TM)<br>Patients who have been treated with a single, intra-articular injection. | Device: Autologous Protein Solution APS(TM)<br>* A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months. | Up to 6 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Using Rescue Medication | Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee. | Up to 6 months post-injection | 
| Pain Score | The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. | 
| Stiffness Score | Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. | 
| Physical Function Score | Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APS, Autologous Protein Solution, Osteoarthritis, Injection