Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study

• Status: Completed
• Trial end date: 2020-10-10
• Target enrollment: 0
• Participant gender: All

Summary

The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second mechanism may be the increase in the anabolic factors and a decrease in degenerative factors in the joint. The Investigators propose to quantify the concentration of HA and selected anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While the treatment provided is designed to provide pain relief for symptoms, the purpose of this study is to learn more information about the impact of amniotic tissue allografts on inflammatory markers and growth factors in the knee joint.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Foundation for Sports Medicine and Arthritis Research; The Stone Research Foundation for Sports Medicine and Arthritis
• Treatments: Hyaluronic Acid; Mitogens

Criteria

Inclusion Criteria:

1. Patients age 18 and over

2. Previous diagnosis of knee OA,

3. Kellgren-Lawrence grade of 2 - 4

4. Minimum Visual Analogue Scale (VAS) pain score of 3 on a scale of 0 - 10 where 0 is no pain and 10 is the highest level of pain

5. Can give written informed consent

Exclusion Criteria:

1. Receipt of HA, Platelet Rich Plasma (PRP) or amniotic cell injections in the previous 6 months

2. Recent history of surgery to the same joint in the previous 3 months

3. A clinical diagnosis of inflammatory arthritis made by history, examination or serology

4. An active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated within the previous 3 months

5. A history of chronic alcohol or drug abuse during the six months prior to the study

6. Clinically documented acute or unstable concomitant disease, other than the condition to be treated in this study that might be a confounding reason for the presence of pathogens (i.e. renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases)

7. Systemic or intra-articular administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immune stimulating or immunosuppressive agents

8. Participation in any other investigational drug or device trial during the 30 days prior to screening visit or who will receive such a drug or device during the course of this study

9. Pregnant females

10. Subject is unable to understand verbal and/or written English