Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis

Study Overview
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Brief Summary
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This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.

Detailed Description
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While PRP shows promise in helping restore function to these patients, there are still concerns with PRP's long term outcomes. Another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts. Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMA for osteoarthritis treatment.

Official Title
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Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Combination Product: Pure PRP II
* Combination Product: PureBMC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly assigned to either a PRP intervention group or the BMC intervention group. Knee pain and function outcomes of enrolled patients in the two groups will be compared to determine which treatment is more effective in treating knee osteoarthritis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Platelet Rich Plasma (PRP)<br>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. | Combination Product: Pure PRP II<br>* The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.<br>* Other names: GS60-PURE-II;|
| Other: Bone Marrow Concentrate (BMC)<br>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. | Combination Product: PureBMC<br>* The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.<br>* Other names: BC60-PURE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Change in pain score measurements utilizing patient surveys | Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective International Knee Documentation Committee Subjective Score (IKDC) | Change in pain score measurement utilizing patient surveys | Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, platelet rich plasma (PRP), bone marrow concentrate (BMC)