Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study
Osteoarthritis, Knee
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Stem Cell Therapy, Injection, Hyaluronic Acid, Synovial Fluid
Eligibility Criteria
Inclusion Criteria:
- Patients age 18 and over
- Previous diagnosis of knee OA,
- Kellgren-Lawrence grade of 2 - 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
- Can give written informed consent
Exclusion Criteria:
- Receipt of HA, Platelet Rich Plasma (PRP) or amniotic cell injections in the previous 6 months
- Recent history of surgery to the same joint in the previous 3 months
- A clinical diagnosis of inflammatory arthritis made by history, examination or serology
- 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
- A history of chronic alcohol or drug abuse during the six months prior to the study
- 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)
- Systemic or intra-articular administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immune stimulating or immunosuppressive agents
- 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
- Pregnant females
- Subject is unable to understand verbal and/or written English
Sites / Locations
- Stone Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Saline
Hyaluronic Acid & Saline
Amniotic Tissue & Saline
Amniotic Tissue & Hyaluronic Acid
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml and 1ml of Saline) comprising a total volume of 8.5ml fluid during one procedure.
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Saline) comprising a total of 8.5mL fluid during one procedure.
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Saline and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.