Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: BMAC injection; PRP injection; Gel-One® hyaluronate injection
Intervention description: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.; 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.; Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: knee osteoarthritis; regenerative medicine; orthobiologics; cellular therapy

Summary:

      The purpose of this study is to determine the clinical response to autologous bone marrow
      aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis
      with respect to pain, function, and quality of life at up to 1 year following the
      intervention. Specifically, the clinical response will be compared to baseline and a control
      group treated with a Gel-One® hyaluronate injection to the target knee.
    

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