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

April 17, 2025 updated by: Andrews Research & Education Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research & Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • GS60-PURE-II
Other: 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 Names:
  • BC60-PURE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

EmCyte Corporation
BioSciences Research Associates, Inc

Investigators

  • Principal Investigator: Joshua Hackel, MD, Andrews Institute for Orthopaedic & Sports Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2013

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EmCyte

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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