Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee

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