Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis (EmCyte)
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, osteoarthritis, platelet rich plasma (PRP), bone marrow concentrate (BMC)
Eligibility Criteria
Inclusion Criteria:
- Male or female age 18-80 years
- Knee osteoarthritis
- Subjects must present with pain or swelling to target knee for at least 4 months
- Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation
- Must be willing and able to provide informed consent
- Willing and able to return for scheduled follow-up visits
Exclusion Criteria:
- Major mechanical axis deviation of more than 50% into either compartment (varus or valgus )
- Have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months
- History of the following medical conditions:
- diabetes
- autoimmune disorders
- disorders requiring immunosuppression
- rheumatoid arthritis
- hemophilic arthropathy
- infectious arthritis
- Charcot's knee
- Paget's disease of the femur or tibia
- Cancer
- Ongoing infectious disease
- Significant cardiovascular, renal or hepatic disease
Sites / Locations
- Andrews Research & Education Foundation
Arms of the Study
Arm 1
Arm 2
Other
Other
Platelet Rich Plasma (PRP)
Bone Marrow Concentrate (BMC)
Blood will be drawn from the patient using the Pure PRP II system into a syringe with anticoagulant (sodium citrate). 1 mL of blood will be separated and sent to a lab for analysis. Remaining blood will be separated into a single concentrating device and centrifuged to separate red blood cells from plasma and platelets. The plasma and platelets will be separated off with a syringe and re-centrifuged to separate the platelets from the plasma. 1 mL will be separated and sent to a lab for analysis leaving 6 mL for injection. Both the 1 mL of blood and the 1 mL of PRP will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F. Physician will then inject the PRP into the affected knee joint.
Bone marrow will be harvested from the posterior iliac crest using the PureBMC system. 50 mL of bone marrow will be drawn into one syringe containing 10 mL of sodium citrate. Marrow will be filtered and centrifuged for separation of the bone marrow concentrate. Plasma and cell concentrate will be separated off with two syringes and re-centrifuged to separate the cell concentrate from the plasma. After plasma is drawn off, BMC will be drawn into a syringe for injection into affected knee. BMC production procedure results in 7 mL of product and 1 mL will be separated and sent to a lab for analysis. Both 1 mL of BMA and 1 mL of BMC will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F.