Clinical trial: The Effect of Intra-Articular Injection of RegenoGel-OSP™ (Self-Plasma) and RegenoGel™ on Knee Pain in People Suffering From Osteoarthritis (NCT03479749)

Eligibility criteria:
Inclusion Criteria:

          1. Subject has signed and dated the informed consent form

          2. Subject is a male or female between 55≤ and ≤ 80 years of age

          3. Subject is experiencing pain in the intended study knee with an average VAS score of ≥
             5 over the last week prior to screening.

          4. 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.

          5. Subject has a Body Mass Index (BMI) between 18.5 and 35

        Exclusion Criteria:

          1. 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.

          2. Subject is experiencing pain in both knees with a VAS score of ≥ 5.

          3. Subject had any intra-articular injections to the intended study knee within 3 months
             prior to Screening.

          4. Subject has less than 12-month life-expectancy.

          5. 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.

          6. Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis or any other
             inflammatory condition associated with arthritis

          7. Subject has a wound in the area of the intended study knee

          8. 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.

          9. Subject has known sensitivity to any of the treatment components, egg, rubber or latex

         10. Subject has a history of anaphylactic shock or other severe systemic response or other
             adverse event to human blood products

         11. Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome
             (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease

         12. Subject has ever had cellulitis of the lower extremities, a peripheral vascular
             disease, or a personal history of clotting disorders.

         13. Subject has had cancer in the past 3 years or surgery involving the chest, abdomen,
             pelvis, or lower extremities in the past year

         14. Subject received any treatment with investigational device or product within 30 days
             prior to Visit l

         15. 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

         16. Subject is receiving an antiplatelet and/or anticoagulation medicines (other than
             Aspirin)

         17. Subject ever abused drugs or alcohol (self-reported)

         18. Subject received a blood transfusion within 6 months prior to Screening.

         19. Subject donated blood or blood products within 3 months prior to Screening

         20. 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

         21. 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.

         22. Subject suffering from severe OA and is not able to walk due to pain

         23. Pregnant or lactating woman
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1