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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289416
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
EmCyte Corporation
BioSciences Research Associates, Inc
Information provided by (Responsible Party):
Andrews Research & Education Foundation

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE September 21, 2017
Last Update Posted Date March 6, 2020
Actual Study Start Date  ICMJE December 5, 2013
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis
Official Title  ICMJE Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
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)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Combination Product: Pure PRP 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.
    Intervention: Combination Product: PureBMC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2020)
90
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2017)
120
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289416
Other Study ID Numbers  ICMJE EmCyte
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrews Research & Education Foundation
Study Sponsor  ICMJE Andrews Research & Education Foundation
Collaborators  ICMJE
  • EmCyte Corporation
  • BioSciences Research Associates, Inc
Investigators  ICMJE
Principal Investigator: Joshua Hackel, MD Andrews Institute for Orthopaedic & Sports Medicine
PRS Account Andrews Research & Education Foundation
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP