Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561, United States
NCT Number: NCT03289416
This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Gulf Breeze, Florida, 32561, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: GS60-PURE-II
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 names: BC60-PURE
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest
Andrews Research & Education Foundation
Other
Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial
Acronym: EmCyte
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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