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

NCT03289416 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EmCyte
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee; osteoarthritis; platelet rich plasma (PRP); bone marrow concentrate (BMC)

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements

  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 Outcomes (1)

• Subjective International Knee Documentation Committee Subjective Score (IKDC)

  Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Study Arms (2)

Platelet Rich Plasma (PRP)

OTHER

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

Bone Marrow Concentrate (BMC)

OTHER

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

Interventions

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.

Also known as: GS60-PURE-II

Platelet Rich Plasma (PRP)

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.

Also known as: BC60-PURE

Bone Marrow Concentrate (BMC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• EmCyte Corporation: collaborator
• BioSciences Research Associates, Inc: collaborator

Study Sites (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (16)

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  PMID: 16385518 BACKGROUND

• 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.

  PMID: 22513879 BACKGROUND

• 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.

  PMID: 21831567 BACKGROUND

• 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.

  PMID: 23104611 BACKGROUND

• 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.

  PMID: 23299850 BACKGROUND

• 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.

  PMID: 22069972 BACKGROUND

• 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.

  PMID: 23176112 BACKGROUND

• 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.

  PMID: 24075613 BACKGROUND

• 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.

  PMID: 10023285 BACKGROUND

• 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.

  PMID: 16418021 BACKGROUND

• 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.

  PMID: 10338172 BACKGROUND

• 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.

  PMID: 23809450 BACKGROUND

• 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.

  PMID: 24046512 BACKGROUND

• 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.

  PMID: 19962065 BACKGROUND

• 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.

  PMID: 35289231 DERIVED

• 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.

  PMID: 32118081 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Jessica Truett
• Organization: Andrews Research and Education Foundation

jessica.truett@andrewsref.org

8509168570

Study Officials

• Joshua Hackel, MD

  Andrews Institute for Orthopaedic & Sports Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 21, 2017
• Study Start: December 5, 2013
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)