Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis
NCT ID: NCT03289416
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2013-12-05
2020-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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EmCyte Corporation
INDUSTRY
BioSciences Research Associates, Inc
UNKNOWN
Andrews Research & Education Foundation
OTHER
Responsible Party
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Principal Investigators
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Joshua Hackel, MD
Role: PRINCIPAL_INVESTIGATOR
Andrews Institute for Orthopaedic & Sports Medicine
Locations
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Andrews Research & Education Foundation
Gulf Breeze, Florida, United States
Countries
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References
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Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.
Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.
Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.
Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
Li M, Zhang C, Ai Z, Yuan T, Feng Y, Jia W. [Therapeutic effectiveness of intra-knee-articular injection of platelet-rich plasma on knee articular cartilage degeneration]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 Oct;25(10):1192-6. Chinese.
Filardo G, Kon E, Di Martino A, Di Matteo B, Merli ML, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Nov 23;13:229. doi: 10.1186/1471-2474-13-229.
Vaquerizo V, Plasencia MA, Arribas I, Seijas R, Padilla S, Orive G, Anitua E. Comparison of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with symptomatic osteoarthritis: a randomized controlled trial. Arthroscopy. 2013 Oct;29(10):1635-43. doi: 10.1016/j.arthro.2013.07.264.
Convery PN, Milligan KR, Quinn P, Scott K, Clarke RC. Low-dose intra-articular ketorolac for pain relief following arthroscopy of the knee joint. Anaesthesia. 1998 Nov;53(11):1125-9. doi: 10.1046/j.1365-2044.1998.00582.x.
Ng HP, Nordstrom U, Axelsson K, Perniola AD, Gustav E, Ryttberg L, Gupta A. Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):26-33. doi: 10.1016/j.rapm.2005.09.009.
Gupta A, Axelsson K, Allvin R, Liszka-Hackzell J, Rawal N, Althoff B, Augustini BG. Postoperative pain following knee arthroscopy: the effects of intra-articular ketorolac and/or morphine. Reg Anesth Pain Med. 1999 May-Jun;24(3):225-30. doi: 10.1016/s1098-7339(99)90132-3.
Beitzel K, McCarthy MB, Cote MP, Apostolakos J, Russell RP, Bradley J, ElAttrache NS, Romeo AA, Arciero RA, Mazzocca AD. The effect of ketorolac tromethamine, methylprednisolone, and platelet-rich plasma on human chondrocyte and tenocyte viability. Arthroscopy. 2013 Jul;29(7):1164-74. doi: 10.1016/j.arthro.2013.04.006.
Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951. eCollection 2013.
Saw KY, Hussin P, Loke SC, Azam M, Chen HC, Tay YG, Low S, Wallin KL, Ragavanaidu K. Articular cartilage regeneration with autologous marrow aspirate and hyaluronic Acid: an experimental study in a goat model. Arthroscopy. 2009 Dec;25(12):1391-400. doi: 10.1016/j.arthro.2009.07.011. Epub 2009 Sep 17.
Anz AW, Plummer HA, Cohen A, Everts PA, Andrews JR, Hackel JG. Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. Am J Sports Med. 2022 Mar;50(3):618-629. doi: 10.1177/03635465211072554.
Anz AW, Hubbard R, Rendos NK, Everts PA, Andrews JR, Hackel JG. Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 1 Year: A Prospective, Randomized Trial. Orthop J Sports Med. 2020 Feb 18;8(2):2325967119900958. doi: 10.1177/2325967119900958. eCollection 2020 Feb.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EmCyte
Identifier Type: -
Identifier Source: org_study_id
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