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Completed

NCT Number: NCT03289416

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pure PRP II

Combination Product

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

PureBMC

Combination Product

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

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements

    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

Secondary outcomes

  1. Subjective International Knee Documentation Committee Subjective Score (IKDC)

    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

Sponsors and collaborators

Lead sponsor

Andrews Research & Education Foundation

Other

Collaborators

  • BioSciences Research Associates, Inc
  • EmCyte Corporation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2017
Registry last updated
Apr 20, 2025

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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