The Effect of Intra-Articular Injection of RegenoGel-OSP™ (Self-Plasma) and RegenoGel™ on Knee Pain in People Suffering From Osteoarthritis

Study Overview
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Brief Summary
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This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™, RegenoGel or placebo treatment in the first treatment. In the second treatment after interval of three months all the subjects will necessarily receive one of the two active products. The follow-up period will continue for one year after first treatment.

Official Title
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Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Intra-articular Injection of RegenoGel-OSP and RegenoGel as a Treatment of Osteoarthritis (OA)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: RegenoGel-OSP, RegenoGel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed and dated the informed consent form Subject is a male or female between 55≤ and ≤ 80 years of age Subject is experiencing pain in the intended study knee with an average VAS score of ≥ 5 over the last week prior to screening. Subject with 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. This grade will be determined by the physician discretion and also by the Computerized, Automated X-ray-based Scoring and determination of Kellgren Lawrence software. Both methods should indicate a KL grade between II-IV in order for a subject to be eligible for the study. Subject has a Body Mass Index (BMI) between 18.5 and 35 Exclusion Criteria: Subjects with history of significant knee trauma to the intended study knee or with previous arthroscopic surgery of the intended study knee within the last 3 months preceding screening. Subject is experiencing pain in both knees with a VAS score of ≥ 5. Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening. Subject has less than 12-month life-expectancy. Subject is on chronic administration of pain medications (especially opioid pain relievers) and is unable to stop them from the day before each study visit through completion of the study visit. Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis or any other inflammatory condition associated with arthritis Subject has a wound in the area of the intended study knee Subject has 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 or placebo. Subject has known sensitivity to any of the treatment components, egg, rubber or latex Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease Subject has ever had cellulitis of the lower extremities, a peripheral vascular disease, or a personal history of clotting disorders. Subject has had cancer in the past 3 years or surgery involving the chest, abdomen, pelvis, or lower extremities in the past year Subject received any treatment with investigational device or product within 30 days prior to Visit l Subject has any recent (acute) or chronic medical, psychiatric, or social problem that might: 1) interfere with the Subject's performance or completion of the trial; 2) obfuscate the Subject's study data; or 3) render the Subject unable to understand the nature, scope, and possible consequences of the study Subject is receiving an antiplatelet and/or anticoagulation medicines (other than Aspirin) Subject ever abused drugs or alcohol (self-reported) Subject received a blood transfusion within 6 months prior to Screening. Subject donated blood or blood products within 3 months prior to Screening Subject has any elective surgery of any kind to the lower extremities or elective surgery requiring general anesthesia scheduled during the course of the trial Subject suffering from severe form of grade KL4 such as total cartilage loss with bone on bone as determined by the investigator or by the Computerized, Automated X-ray-based Scoring software. Subject suffering from severe OA and is not able to walk due to pain Pregnant or lactating woman

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RegenoGel-OSP - RegenoGel-OSP<br>First injection- the patients will receive RegenoGel-OSP; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP also | Device: RegenoGel-OSP, RegenoGel<br>* RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.<br>|
| Experimental: RegenoGel - RegenoGel<br>First injection- the patients will receive RegenoGel; Second injection (after 3 months interval)- the patients will receive RegenoGel also | Device: RegenoGel-OSP, RegenoGel<br>* RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.<br>|
| Placebo Comparator: Placebo - RegenoGel-OSP<br>First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP | Device: RegenoGel-OSP, RegenoGel<br>* RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.<br>|
| Placebo Comparator: Placebo - RegenoGel<br>First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel | Device: RegenoGel-OSP, RegenoGel<br>* RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) | Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here. | Three months | 
| Efficacy assessment on change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. | Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (Pain both at rest and during exercise). | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) | Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here. | Six months | 
| Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (pain both at rest and during exercise). | Six months | 
| Change in the subject´s activity in response to treatments based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Change in the subject´s activity in response to treatments based on the entire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. | Three and Six months | 
| Change from baseline in quality of life in response to treatments using the SF-12 health survey. | Change from baseline in quality of life in response to treatments using the SF-12 health survey. | Three and Six months | 
| Change in Subjective International Knee Documentation Committee score (IKDC). | Change in Subjective International Knee Documentation Committee score (IKDC). | Three and Six months | 
| Clinical safety and tolerability assessments which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms. | Clinical safety and tolerability assessments up to 12 months post 1st injection which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms. | Up to 12 months post first injection |