Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

Study Overview
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Brief Summary
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This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.

Detailed Description
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This study is a prospective, multi center randomized double blind, two arm study. 90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.

Official Title
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Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: ACP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is 18 to 70 years of age. The subject presents with complaints of continued pain of primary knee for at least 6 weeks. The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening. The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities Exclusion Criteria: Grade I and IV on the knee Kellgren-Lawrence grading scale Subject has clinically 3+ effusion of the target knee (stroke test grading system). Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray. Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening. Viscosupplementation in any joint in the past six months. Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin). Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months Subject has inflammatory disease of either knee other than OA. Subject with underlying medical conditions that could interfere with the evaluation of the outcome. Subject with positive pregnancy test, or breast feeding. Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months. Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Subject has rheumatoid arthritis or gout Subject has a history of or a current infection at the affected joint. Subject with plans to undergo any elective orthopedic surgery in the next 12 months. Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Conditioned Plasma (ACP)<br>3 Intra-articular (IA) injections at 1 week intervals | Device: ACP<br>* Autologous Conditioned Plasma<br>|
| Placebo Comparator: Normal Saline (NS)<br>3 NS Intra-articular (IA) injections at 1 week intervals | Other: Placebo<br>* Three Normal Saline IA injections of 3-8 mL at 1-week intervals.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey | The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain. | 6 month visit |