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Platelet Rich Plasma/PRP Tendons and ligaments connect muscles to bones, making it possible to do all kinds of physical activities. Overuse or damage to tendons over a long period of time causes collagen fibers that make up the tendons to form small tears, a condition called tendinosis. Ligaments are composed of collagen fibers and hold bones together, stabilizing joints and controlling the range of motion. Tendons and ligaments have poor blood supply and they do not easily recover from damage caused by sprains, strains, and repetitive motion. Anna Stahl President & CEO, LifeForm Healing Research, LLC
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- 2. New Concentrating Device for 2015 544E THE NEW 5 MINUTE SOLUTION EmCyte Corporation has become a leader in autologous cellular biologics with the new Pure® and 544E Concentrating Device for 2015. These systems provide patients with the best opportunity for rapid recovery and provide practitioners with the most advanced clinical point of care experience. These systems are developed to meet every clinical requirement, giving the physician a better clinical choice.
- 3. 1. Pure PRP® is a unique blend of highly concentrated platelets and growth factors suspended in a bath of plasma. 2. Pure PRP® is the only PRP composition that provides platelet concentrations of up to 9 times baseline in 7mLs, with 99% of the RBCs REMOVED. 3. Pure PRP® can be processed with or without inflammatory neutrophil granulocytes. Protocol A removes 99% of the granulocytes. Protocol B collects approximately 99% of the granulocytes. This provides the clinician with a clinical option for the patient requirement. 4. Pure PRP® greatly enhances monocyte concentrations, up to 7 times baseline. Monocytes are the largest of all leukocytes and are characteristically non-inflammatory phagocytic cells. They elicit an immune response which last for longer periods of time (months rather than days when compared to neutrophils). 5. BEST OF ALL - Pure PRP® is naturally pH balanced, averaging 7.4. It requires no buffering. Basic Science
- 4. Reduced necrotic granulocytes reduces post injection inflammation in the joint space Lower viscosity allows smaller injection needles. Higher fibrinogen levels provide a natural matrix scaffold for platelet retention The Effect of Platelet-Rich Plasma Formulations and Blood Products on Human Synoviocytes Implications for Intra-articular Injury and Therapy Hillary J. Braun,*y BA, Hyeon Joo Kim,* PhD, Constance R. Chu,* MD, and Jason L. Dragoo,*z MD Investigation performed at Stanford University, Palo Alto, California, USA Conclusion: Treatment of synovial cells with PRP rich in RBCs resulted in significant cell death and pro-inflammatory mediator production. Clinical Relevance: Clinicians should consider using, RBC-free formulations of PRP when administering intra-articularly. Pure PRP® vs Conventional PRP
- 5. Comparison Data Pure PRP® vs. SmartPrep® vs Angel Study Date 5/5/2015 8 Patient Comparison Study PurePRP® SmartPrep® Angel Platelet Concentration 6.6x 5.66x 3.94x Platelet Yield 80% 61% 45% Total Deliverable Platelets 8,555,880,000 7,193,280,000 5,084,920,000 Granulocytes 2% 1% 3% Monocytes 77% 27% 35% Average PRP Volume 7.3 7.1 7.2 Pure PRP® vs SmartPrep® vs Angel Principle Investigator(s): Dr. Robert Mandle, Ph.D. Children’s Hospital, Harvard Medical School The CBR Institute for Biomedical Research Biosciences Research Associates, Boston, MA.
- 6. NOT ALL PRP IS CREATED EQUAL. PurePRP® is High Yielding PRP PurePRP® 1. Provides the highest concentration of deliverable platelets and growth factors in a 7-10mL treatment sample. These growth factors include SDF1α, PDGF, VEGF, TGFβ1 2. Contain high concentrations of agranular monocytes, the largest of all leukocytes. They are non inflammatory leukoucytes that provide the anti- microbial and cell migration and proliferation support that is needed for active wound repair. 3. Has 99% of the RBC removed. It is shown that RBCs may have an inflammatory and cytotoxic effect to synovial tissue in the joint. High Yielding PRP
- 13. Preparation Technique Protocol A Aspirate PPS leaving the RBC behind Protocol A processes PurePRP® without red blood cells or neutrophil granulocytes. This protocol is used when powerful healing without inflammatory activity is required at the application site. This protocol is also the low viscosity solution to a viable PRP product, providing very high concentrations of platelets in a bath of non-viscous plasma. This protocol has also been reported to reduce the potential for pain at the application site. It is the most frequently used protocol. Protocol B Aspirate PPS and an additional 1mL of RBC Protocol B processes PurePRP® with low red blood cell counts and very high neutrophil cell recoveries. This protocol is used when the phagocytic powers of neutrophils are needed to help fight infectious processes at the application site. This protocol produces the highest chemoattractant activity and significantly increases regeneration potential. Once the neutrophils have completed phagocytosis, they become apoptic cells and are subsequently removed, thereby also eliminating the inflammatory activity. Platelet Plasma Suspension Preparation
- 20. The GenesisCS 544E Platelet and Bone Marrow Concentrating System is an improved single spin processing system that fast and efficient. 1. They are now the fastest and most efficient 60mL concentrating systems available. 2. Prepare 7mL of PRP or BMC, with high concentrations of regenerative cells, in a SINGLE 5 MINUTE SPIN. 3. These specialized systems were designed to accommodate physicians that run a busy practice and mandate superior performance outcomes in a short processing cycle. 544E THE NEW 5 MINUTE SOLUTION
- 21. The Secret to Improved Performance The key to the 544E Concentrating System is the new ClearVUE Conical Piston. The piston is specially designed to greatly improve the collection of the cell concentrate buffycoat layer. The primary feature of the new ClearVUE Conical Piston is it's the deep conical shape. The deep conical design perfectly directs the collection of the cell concentrate buffycoat. This provides quality platelet rich plasma and bone marrow concentrate with near perfect collection yields. The ClearVUE Conical Piston also features enhanced handling of the concentrating device with frictionless motion and a CLEAR VIEW of the buffycoat while its being aspirated, further instilling confidence in the quality of the end product. 544E THE NEW 5 MINUTE SOLUTION Trapped Plasma & Cell Buffycoat Collected Plasma & Cell Buffycoat
- 23. Pre-treatment Clinical Presentation: • AOFAS scores averaged 34 (range, 20 to 60) • Pre-treatment MRI findings of chronic tendinitis were seen in 18 of 18 patients • All MRI patients demonstrated significant Achilles swelling • Four had tendon calcifications and six displayed partial Achilles tendon tears • Ultrasound studies were completed on the remaining 12 patients and all studies demonstrated Achilles swelling Platelet Rich Plasma Treatment for Chronic Achilles Tendinosis Raymond Rocco Monto, MD Nantucket, MA FOOT & ANKLE INTERNATIONAL Copyright © 2012 by the American Orthopaedic Foot & Ankle Society DOI: 10.3113/FAI.2012.0379
- 24. Post PRP injection Clinical Presentation: • Average AOFAS scoring at 1-month post-PRP treatment dramatically improved to 84 (range, 80 to 87) • At 2 months post-PRP treatment the average AOFAS score was 87 (range, 84 to 90) • AOFAS scoring at 6 months post PRP averaged 92 (range, 76 to 100) • AOFAS scores at 24 months remained elevated at 88 (range, 81 to 100) Platelet Rich Plasma Treatment for Chronic Achilles Tendinosis Raymond Rocco Monto, MD Nantucket, MA FOOT & ANKLE INTERNATIONAL Copyright © 2012 by the American Orthopaedic Foot & Ankle Society DOI: 10.3113/FAI.2012.0379
- 25. A. MRI of Achilles tendon pretreatment with PRP. Note signal change and partial tearing at Achilles insertion (AOFAS score 34 / unable to work or participate in sports). B. MRI same patient 6 months post-treatment with PRP. Note resolution of signal changes and healing of partial tear at the calcaneal insertion of the Achilles tendon (AOFAS score 100 / working and playing ice hockey). Platelet Rich Plasma Treatment for Chronic Achilles Tendinosis Raymond Rocco Monto, MD Nantucket, MA FOOT & ANKLE INTERNATIONAL Copyright © 2012 by the American Orthopaedic Foot & Ankle Society DOI: 10.3113/FAI.2012.0379 A B
- 26. A. MRI of Achilles tendon pretreatment with PRP. Note signal changes and partial insertion tearing (AOFAS score 43 / working but unable to play golf). B. MRI same patient 6 months after PRP treatment. The insertional tear has healed and the swelling of the Achilles tendon has diminished. (AOFAS score 84 / working and returned playing golf. The AOFAS score rose to 90 at 24 months follow up and the patient returned to all athletics). Platelet Rich Plasma Treatment for Chronic Achilles Tendinosis Raymond Rocco Monto, MD Nantucket, MA FOOT & ANKLE INTERNATIONAL Copyright © 2012 by the American Orthopaedic Foot & Ankle Society DOI: 10.3113/FAI.2012.0379 A B
- 27. METHODS : One Hundred forty patients with elbow epicondylar pain were evaluated in this study RESULTS : Eight weeks after the treatment, the platelet-rich plasma patients noted 60% improvement in their visual analog pain scores versus 16% improvement in control 1. At 6 months, the patients treated with platelet-rich plasma noted 81% improvement in their visual anoalog pain scores ( P=.0001 ) 2. At final follow-up ( mean, 25.6 months; range, 12-38 months ), the platelet rich plasma patients reported 93% reduction in pain compared with before the treatment ( P<.0001 ) Treatment of chronic elbow tendinosis with platelet-rich-plasma Mishra A, Pavelko T. Am J Sports Med. 2006 Nov;34(11):1774-8. Epub 2006 May 30. Links
- 34. 1. PureBMC® is a unique blend of VIABLE concentrated platelets, hematopoetic stem cells, mesenchymal stem cells and total nucleated cells in BMA plasma containing a hematocrit of less than 25%. 2. PureBMC® provide HSC concentrations of up to 13 times the baseline and TNC concentrations of up to 9 times the baseline, all in 7mL of PureBMC ® with a hematocrit of less than 25% 3. PureBMC® also has the ability to produce large quantities of colony forming units which is indicative of it’s MSC growth propensity 4. PureBMC® is specially unique because it can be prepared with Citrate anticoagulant or with Heparin. It’s been shown that either way preserves the platelet functionality and viability. This single feature significantly improves the BMC effectiveness, because the platelet mediators and cytokines are at optimal performance 5. BEST OF ALL - PureBMC® is naturally pH balanced with an average pH of 7.4. It requires no buffering
- 35. 1. Mesenchymal stem cells (MSC) are multipotent stromal cells that can differentiate into a variety of cell types. These cell types primarily include cartilage, bone and adipose cells 2. Mesenchymal stem cells are found in very small quantities in bone marrow aspirate, making the concentrating capabilities of PureBMC® more vital to the physician 3. Adipose tissue is one of the richest sources of MSCs, it has more than 500 times more stem cells in 1 gram of fat than in 1 gram of aspirated bone marrow but MSCs derived from PureBMC® maintains effectiveness because it has a great capacity for self renewal 4. Stem Cells give rise to colony forming units= fibroblastic ( CFU-F ). The higher the number of CFU-F, the higher the number of stem cells Basic Science
- 38. Basic Science Age and Gender Effect of Bone Marrow Aspirate 1. Stem Cell concentration is declined with age 2. Stem Cell concentration is lower in osteoporotic patients References : 1. “ Skeletal progenetor cells and ageing human populations “ Oreffo R., et al, Clinical Science 1998, 94, 549-555 2. “ Age and Gender-Related Changes in the Cellularity of Human Bone Marrow and the Prealence od Osteoblastic Progenitors “. Muschler G., et la, Journal of Orthopedic Research 19 (2001) 117-125
- 39. Performance Data BMA BMC Concentration Results (7mL BMC) Nucleated Cells/mL 134,000,000 7,985,000,000 6x Platelets/mL 109,500,000 1,462,000,000 13x CD 34+ Cells/mL 73,395 584,435 8x Colony Forming Units CFU-F/mL 55.65 614 11x Data Preparation by: Robert Mandle, PhD BioSciences Research Associates, Inc. Samples provided by EmCyte Customers Report Edition 1, Date: March 19,2015
- 41. Draw 50mL of bone marrow aspirate from the patient filling the syringe to 60mL Preparation Technique
- 46. Aspirate the BMA plasma into the 60mL syringe. Aspirate until the pipe fills with BMA RBCs. Then open the stopcock to the 3mL syringe and aspirate 2mL of BMA RBC Aspirate Cell Concentrate 2mL BMA RBC BMA Plasma Preparation Technique
- 47. Transfer the BMA RBC 1st and then the BMA plasma into the Concentrating Accessory Transfer Cell Concentrate Preparation Technique
- 52. 1. Adipose graft is the most readily available and least invasive source of adult stem cells 2. Adipose Stem Cells can differentiate into bone, cartilage, fibrous tissue, fat or muscle 3. Adipose Stem Cells give rise to colony forming units= fibroblastic ( CFU-F ) 4. The higher the number of CFU-F, the higher the number of stem cells Reference : 1. “Connective Tissue Progenitors : Practical Concept for Clinical Applications“ Muschler G. et al. CORR No. 395, Feb. 2002 2. “Skeletal progenitor cells and ageing human populations“ Oreffo R., et al, Clinical Science 1998, 94, 549-555 Basic Science Adipose Stem Cells
- 55. Pain Measurements of Patients Separated into the Six Age Ranges Safety Reporting on Implantation of Autologous Tissue Derived Stem Cells with Platelet Rich Plasma into Human Articular Joints Jaewoo Pak, Jae-Jin Chang, Jung Hun Lee, Sang Hee Lee BMC Musculoskelet Disord. 2013;14(337) Basic Science Adipose Stem Cells Age range (years) Relative mean VAS score Hip bone (AVN) Knee and Hip cartilage Combined Pre 1 mo. 3 mo. Pre 1 mo. 3 mo. Pre 1 mo. 3 mo. 18 ~ 29 10 8.50 ± 0.33 - 10 5.80 ± 1.40 3.00 ± 0.62 10 6.57 ± 1.53 3.00 ± 1.38 30 ~ 39 10 5.20 ± 0.83 3.40 ± 0.54 10 7.71 ± 0.75 5.86 ± 0.89 10 6.67 ± 1.30 4.83 ± 1.64 40 ~ 49 10 6.33 ± 0.25 6.33 ± 0.23 10 6.38 ± 1.67 4.45 ± 1.59 10 6.28 ± 1.71 4.89 ± 1.97 50 ~ 59 10 10* 6* 10 6.81 ± 1.10 4.21 ± 1.27 10 7.20 ± 1.16 4.31 ± 1.99 60 ~ 69 10 9* 9* 10 6.75 ± 1.85 4.97 ± 1.60 10 6.75 ± 1.83 5.21 ± 1.92 70 ~ 80 - - - 10 5.00 ± 0.69 2.44 ± 0.62 10 5.00 ± 0.97 2.44 ± 1.93