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| Name | Class |
|---|---|
| EmCyte Corporation | INDUSTRY |
| BioSciences Research Associates, Inc | UNKNOWN |
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This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective International Knee Documentation Committee Subjective Score (IKDC) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Hackel, MD | Andrews Institute for Orthopaedic & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Research & Education Foundation | Gulf Breeze | Florida | 32561 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16385518 | Background | 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. | |
| 22513879 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient Hospitalized due to Unrelated Ailments | General disorders | Systematic Assessment | Subject fell off of her horse on 3 Feb 2017 and sustained a right proximal humerus fracture. Subject was admitted to the ER at Baptist hospital in Pensacola on 3 Feb 2017, had surgery performed on 4 Feb 2017, and was discharged on 5 February 2017. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Truett | Andrews Research and Education Foundation | 8509168570 | jessica.truett@andrewsref.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2017 | Feb 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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| 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. |
|
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| 21831567 | 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. |
| 23104611 | 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. |
| 23299850 | 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. |
| 22069972 | 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. |
| 23176112 | 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. |
| 24075613 | 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. |
| 10023285 | 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. |
| 16418021 | 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. |
| 10338172 | 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. |
| 23809450 | 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. |
| 24046512 | 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. |
| 19962065 | 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. |
| 35289231 | Derived | 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. |
| 32118081 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Subjective International Knee Documentation Committee Subjective Score (IKDC) | Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 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. | 0 | 49 | 2 | 49 | 0 | 49 |
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| Patient Withdrawn due to Unrelated Ailments | Immune system disorders | Non-systematic Assessment | Subject called the CRC. Subject stated that they saw a doctor due to pain in their arm and it was found out that the arm was broken possibly due to multiple myeloma. Subject verbally stated over the phone desire to withdraw from the study. |
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| 3 Months |
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| 6 Months |
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| 9 Months |
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| 12 Months |
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