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Regenerative Medicine for Spinal Fusion

Regenerative Medicine for Spinal Fusion. SpineSmith LP Marrow Express (MXP) System SpineSmith Partners, LP 93 Red River Austin, Texas 78701 www.spinesmithusa.com. Spine Smith MXP Cell Concentration System. Bone marrow harvested from the iliac crest Autologous bone marrow derived cells

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Regenerative Medicine for Spinal Fusion

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  1. Regenerative Medicine for Spinal Fusion SpineSmith LP Marrow Express (MXP) System SpineSmith Partners, LP 93 Red River Austin, Texas 78701 www.spinesmithusa.com

  2. Spine Smith MXP Cell Concentration System • Bone marrow harvested from the iliac crest • Autologous bone marrow derived cells • Bone marrow-derived MSCs demonstrated to be multipotent • Requires system to concentrate and recover highest number of cells possible in time frame of surgery

  3. PLT Mono Lymph Gran RBC Separation of Blood or Bone Marrow 1.02 1.04 1.06 1.08 1.10 1.12 1.14

  4. Spine Smith MXP Components 1) MXP Process disposable 3) Centrifuge 4) XpressTraktm Software 2) MXP Canister and Docking Station

  5. Spine Smith MXP Cell Concentration System • Process Disposable • Bone Marrow Aspirate is loaded into disposable • Disposable is loaded into MXP canister • Sterile, non-pyrogenic functionally closed fluid path

  6. Spine Smith MXP Cell Concentration System

  7. Spine Smith MXP Cell Concentration System • MXP Canister & Docking Station • Canister fits into standard centrifuge cup and automates separation • of bone marrow • Optical sensor • Microprocessor-controlled valve • Records QA data • Docking Station recharges canister and permits QA data transfer from MXP to computer

  8. Spine Smith MXP Cell Concentration System • Centrifuge & Software • Each MXP canister fits into 1L centrifuge • buckets • Centrifuge can run 4 or 6 MXP canisters at same time • XpressTRAK™ software QA documentation: • MXP performance, • lot numbers, patient ID, operator ID, searchable data base

  9. Processing Bag Stopcock Valve Product Bag Spine Smith MXP Cell Concentration System Before Centrifugation Filled processing/plasma bag • Bone Marrow • 30cc-200cc RBC Bag Optical Sensor

  10. During Centrifugation RBC Stem cells (WBC) • 1,400 RCF’s • Stratification of bone marrow components Eventual red cell interface Opto G-Force Valve Closed Spine Smith MXP Cell Concentration System

  11. Spine Smith MXP Cell Concentration System After High Speed Centrifugation • 1,400 RCF’s • Cell stratification complete after 20 minutes Plasma RBC Interface Stem cells (WBC) RBC Opto

  12. Spine Smith MXP Cell Concentration System Low Speed Centrifugation – Step 1 RBC Removal Valve turns to direct packed RBC to flow into RBC bag until the cell/plasma interface reaches the level of the optical sensor. The valve then is turned to the off position RBC Bag Optical Sensor Stopcock Valve

  13. Spine Smith MXP Cell Concentration System Low Speed Centrifugation – Step 2 • Stem Cell Harvest 1. Valve is turned to direct the flow of liquid into the product bag. Initially packed RBC, then buffy coat and then plasma enters the product bag. 2. The valve is intermittently opened and closed until the product bag is filled to the operator defined final volume (6-40 mL). The valve rotates to closed position once volume is met. Plasma Stopcock Valve RBC Stem cells Product Bag

  14. Spine Smith MXP Cell Concentration System Human Bone Marrow: Summary of cell recovery

  15. Spine Smith MXP Cell Concentration System Overview • Highest efficiency recovery of stem cells • (> 90%) with high viability • 50% higher recovery compared to other systems • Minimal manipulation of bone marrow product: Reproducible and simple to perform due to automation • Safety product (no foreign materials introduced (avoids washing) and functionally closed system)

  16. BM # MNC TNC CD34 cells CFU Plt 1 88.1 77.7 105.7 89.6 N/A 2 81.9 66.5 101.1 91.8 99.0 3 77.7 69.6 79.2 116.1 189.0 4 103.9 81.6 108.3 114.0 71.6 5 71.7 62.2 100.2 56.2 54.1 6 86.8 76.9 128.5 N/A 80.3 7 N/A N/A 83.5 91.9 58.2 8 104.0 85.6 111.2 127.6 58.0 9 65.0 68.1 85.6 N/A 58.3 10 112.6 94.0 110.6 N/A 84.5 11 86.5 88.7 94.2 N/A 98.6 12 95.5 70.5 103.0 103.8 52.5 13 84.3 72.5 95.4 78.1 59.7 14 95.4 85.2 89.6 76.4 N/A 15 90.8 65.1 95.8 N/A 50.1 16 94.8 83.5 97.0 121.9 61.3 17 102.7 94.2 119.0 96.5 66.2 18 87.7 85.7 N/A N/A 60.4 19 102.6 98.0 102.6 119.5 83.3 20 98.3 83.6 106.9 99.9 74.6 21 58.6 48.5 79.3 N/A 39.5 22 82.7 87.9 83.4 102.6 59.1 Mean 89.1 78.4 99.0 99.1 72.9 SD 13.5 12.3 13.0 19.4 31.5 Spine Smith MXP Cell Concentration System Human Bone Marrow: Summary of cell recovery post Marrow Xpress process

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