iBeam

• Research type

  Research Study

• Full title

  Immunology of Bone Healing in Traumatic Maxillofacial Injuries

• IRAS ID

  335634

• Contact name

  Jehan El-Jawhari

• Contact email

  jehan.el-jawhari@ntu.ac.uk

• Sponsor organisation

  Nottingham Trent University

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  The patients with mandibular fractures who consented to participate in the study will donate samples as described below. The samples will be transferred to the Nottingham Trent University lab per the material transfer agreement. All data (sample and research) and samples will be handled, processed for lab assays, and stored in accordance with NTU health and safety regulations, data management plan, and HTA guidelines.

  The blood samples: 16 ml blood at each of 4 time points (baseline (12-72 hours), two-week, six-week, and 3-6 months after injury). While the three-time points are routine visits, the 3-6 months will be extra for only consented patients. For each visit, a sample will be processed for the following objectives described below.

  • 8 ml of blood using Serum Separator Tube (SST): Serum will be extracted for the quantification of pro-inflammatory and anti-inflammatory cytokines and other immune mediators (complement C3a and C5a). The enzyme-linked immunosorbent assay (ELISA) assays will be used as in previous publications by El-Jawhari et al.

  • 8 ml of blood using an EDTA tube: Blood cells will be extracted to assess the expression levels of immune cell subsets and mediators, as previously used by El-Jawhari et al.

  The following data will be collected from the medical records of the patients who donated blood samples.
  • Age at the time of injury
  • Gender
  • Healing status at samples 1-3
  • Presence of infection at the fracture site
  • Antibiotics prescription

  The bone samples (two pieces of a few millimetres each from 2-3 patients) will be processed for the following objectives:
  • Extraction and quantification of bone-forming cells (mesenchymal stem cells) as published before by El-Jawhari et al.
  • Molecular profiling of these cells as described before by El-Jawhari et al.

  The research data will be analysed using specialised technical and data analysis software.
  

• REC name

  London - City & East Research Ethics Committee

• REC reference

  24/PR/0317

• Date of REC Opinion

  27 Mar 2024

• REC opinion

  Favourable Opinion