P5-2. Design, In Vitro and In Vivo Evaluation of RAW Tissue Harvest System

Project leader: Siamak Saifzadeh (Science & Engineering Faculty, QUT)
Industry partner: Stryker
Fig. 1: Schematic of the sheep tibia segmental defect model used in stage 3 of this project
(Sparks, Saifzadeh and Savi, Nature protocols, accepted for publication)
  1. Stryker has developed a technology platform that allows harvesting bone marrow stem cells (BMSCs) with instruments and methods which promise to significantly increase cell yield.
  2. In a first study, Stryker is seeking an evaluation of the harvested material (volume, viability, cell population, etc…) from different harvesting sites in a sheep model.
  3. In a second study, Stryker seeks to test the regenerative potential of the harvested BMSC’s in a QUT-established and well-characterized segmental defect healing model in sheep tibiae.
Alignment within M3D Innovation:
  1. 1st Study: Multiscale imaging and evaluation to determine quality of the harvested material.
  2. 2nd Study: Scaffold manufacturing using 3D printing and multiscale imaging modalities for quality assurance.
  1. Extensive mock surgeries in sheep cadavers to establish surgical approaches and bone-reaming parameters for harvesting BMSC’s using Stryker’s RAW tissue harvest system.
  2. Determine optimal BMSC harvesting site in a sheep model:
    (a) Acute in vivo study in six sheep to harvest bone marrow from three different sites: femur, tibia, iliac crest.
    (b) Detailed In vitro evaluation of harvest material for volume, cell viability, cell population etc...
  3. In vivo evaluation of regenerative potential of harvested bone marrow in segmental defect study in 30 sheep after 12 months healing time. Evaluation by mechanical testing, microCT imaging and undecalcified histology.
Key Milestones:
  1. Completion of mock surgeries and ethics approval for animal studies.
  2. Completion of acute sheep study and determination of optimal harvest site for subsequent defect healing study.
  3. Demonstration of healing potential of bone marrow harvested using RAW system after implantation in segmental defect model for 12 months.