Clinical trial: Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee (NCT02958267)

Eligibility criteria:
Inclusion Criteria:

          1. Male and female patients 40 to 70 years old

          2. Diagnosed with knee osteoarthritis based on the American College of Rheumatology
             criteria including symptomatic reports and radiographic findings

          3. Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to
             the clinic

          4. Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months

          5. Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate
             level) over the past week

          6. Previous trial of 6 weeks minimum of conservative therapy including physical therapy,
             weight loss, anti-inflammatory medication, or injection therapy

        Exclusion Criteria:

          1. Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale

          2. History of intraarticular viscosupplementation or steroid injection in the target knee
             in the past 6 months at the time of the baseline visit or intraarticular injection
             planned during the trial

          3. History of arthroscopic surgery in the target knee in the past 12 months at the time
             of presentation to the clinic or planned surgery during the trial period (e.g.,
             scheduled for/awaiting arthroscopy or a knee replacement procedure)

          4. Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to
             radiographic osteoarthritis and not symptomatic)

          5. Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of
             hip or ankle

          6. Clinically apparent tense effusion or other acute inflammation of the target knee at
             the time of presentation to the clinic

          7. Active infection of either lower extremity such as cellulitis or any skin disease or
             infection in the area where BMAC is aspirated, blood is drawn, or an injection is
             given

          8. History of diagnosis of any of the following: 1) septic osteoarthritis of any joint,
             2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus,
             crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses

          9. Cruciate/collateral knee ligament instability, ligament laxity, or meniscal
             instability of the target knee

         10. Significant alignment deformity such as varus/valgus of the target knee in the
             judgment of the investigator

         11. Currently pregnant, nursing, or planning to become pregnant during the trial period

         12. Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate;
             hyaluronan products or specifically Gel-One®; cinnamon; bird products such as
             feathers, eggs, or poultry; avian proteins

         13. Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)

         14. Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history
             as ad lib use of over-the-counter analgesics will be allowed in both groups after
             treatment

         15. Current cigarette smoker

         16. Unable to give informed consent

         17. Non-English speaking
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1