Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis (EmCyte)
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|ClinicalTrials.gov Identifier: NCT03289416|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2017
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Combination Product: Pure PRP II Combination Product: PureBMC||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial|
|Actual Study Start Date :||December 5, 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Platelet Rich Plasma (PRP)
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
The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.
Other Name: GS60-PURE-II
Bone Marrow Concentrate (BMC)
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
The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.
Other Name: BC60-PURE
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month ]Change in pain score measurements utilizing patient surveys
- Change in Subjective International Knee Documentation Committee Subjective Score (IKDC) [ Time Frame: Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month ]Change in pain score measurement utilizing patient surveys
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289416
|United States, Florida|
|Andrews Research & Education Foundation|
|Gulf Breeze, Florida, United States, 32561|
|Principal Investigator:||Joshua Hackel, MD||Andrews Institute for Orthopaedic & Sports Medicine|