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Table 3 The designed conceptual framework

From: Guidelines for managing data and processes in bone and cartilage tissue engineering

Sections Features Details
Material Material Type of support material for tissue regeneration exploited in the described experiment.
  Material group Cluster of biomaterials the selected one belongs to: metals, polymers, ceramics, gels, composites, or other.
  Features Morphological and chemico-physical characteristics of the material: bulk properties (total porosity, pore shape and size, pore size distribution, pores volume, pore interconnection); surface properties (chemical/physical functionalization); scaffold properties (sample size and shape [optional]); mechanical properties (such as Bulk modulus and maximum strain) [optional]; chemico-physical properties (such as resorbability and thermoplasticity) [optional].
Cell Cells type Type of cells seeded on the biomaterial, both specifying: the type of cells (for example fibroblasts, osteoblasts, chondrocytes); if they are cell lines (reporting the specific cell line code) or primary cells; in this case, the related extraction protocol.
  Donor organism Species of organism the cells derive from.
  Donor features Age, gender, weight and health status of the donor.
In vitro experiment Cell expansion phase Time or number of expansions (passages) the cells underwent in plate before being seeded in the biomaterial; type of culture medium used during cell expansion; list of the growth factors that have been added to the cell expansion; for each growth factor, the concentration (mg/ml or Mol) must be reported, together with its isoform, if it exists (as in the case of the Transforming Growth Factor-beta isoforms, which play critical roles in growth regulation and development), and the organism species the growth factor comes from.
  Cell culture phase onto the biomaterial Number (cell quantity) or concentration (number of cells per unit of volume) of cells seeded in the biomaterial; cell seeding efficiency; type of culture medium used during cell culture onto the material; cell culture time; list of the growth factors that have been added to the cell culture onto the biomaterial; for each growth factor, the concentration (mg/ml or Mol) must be reported, together with its isoform, if it exists (as in the case of the Transforming Growth Factor-beta isoforms, which play critical roles in growth regulation and development), and the organism species the growth factor comes from.
  Cell characterization Phenotypic/genotypic characterization of cells before their seeding onto biomaterials: evaluation of the expression of cell surface markers through flow cytometry analysis. [optional]
In vivo experiment Host features Species of the host, age [optional], gender, weight and health status of the host.
  Implant features Orthotopic (implant placed in the original, correct site) or ectopic (implant inserted under skin); time the biomaterial remains within the animal model; dimension of the implanted samples [optional]; surgical procedure for the implant.
Results In vitro matrix deposition Evaluation and report of the matrix deposition in in vitro experiments, through morphology, mechanical, biomolecular and biochemical tests (see tests listed below), to obtain a qualitative and quantitative evaluation of scaffold performances. All the results have to be reported specifying the technique used, the applied protocol, the value and measurement unit of the result (in case of quantitative analysis) or the discussion of the result (in case of qualitative analysis).
  In vivo tissue generation Evaluation and report of the growth of tissue in in vivo experiments, through morphology, mechanical, biomolecular and biochemical tests (see tests listed below), to obtain a qualitative and quantitative evaluation of scaffold performances. All the results have to be reported specifying the technique used, the applied protocol, the value and measurement unit of the result (in case of quantitative analysis) or the discussion of the result (in case of qualitative analysis).
  Biomaterial degradation/resorption Kinetics, amount or percentage of biomaterial degradation/resorption over time, either in vitro or in vivo [optional].
  Adverse effects Eventual biomaterial toxicity, evaluated either in vitro (reporting cytotoxicity tests) or in vivo (such as inflammatory response, foreign body reaction, release of degradation by-products)
Tissue/matrix characterization Morphology tests Results of histological and microscopy tests (i.e. SEM, TEM) used to study structures of the generated tissue/matrix (at level of tissue and cell).
  Mechanical tests Values of main indexes (such as Young module) to define mechanical goodness of the generated tissue/matrix.
  Biomolecular tests Genes and proteins level within tissue/matrix cells. Used technique (typically real time RT-PCR or immunohistochemistry; recently high-throughput technologies such as gene expression microarray were introduced). Examples of bone and cartilage markers are type I collagen, RUNX2 protein, osteonectin, osteopontin, osteocalcin, SOX9.
  Biochemical tests Amount of calcium and mineralization (for bone), amount of aggrecan and glycosaminoglycan (for cartilage); the exploited technique.
  1. Features are grouped by 'concepts', and detailed listing mandatory and non-compulsory (flagged as [optional]) aspects to be reported for describing a bone/cartilage experiment.