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Trancell study

Study no FUTU 03/04
Short title

TranCell Study: determining the efficacy of a new dressing product developed in Cell Biology Division in the University of Sheffield, based on the culture of the patientís own keratinocytes onto a transfer dressing

Sponsor Non-commercial study without formal funding
Background

There have been a number of attempts to hasten the healing of chronic neuropathic ulcers by using cultured dermal and epidermal cells from donors (principally allografts from neonatal skin). This represents an attempt to use the same technology, using cells derived from the patientís own skin.

Aim of study Following a small proof of concept study undertaken in Sheffield, this is a small pilot randomized trial
Trial design Double-blind, four centre RCT
Primary endpoint Rate of healing
Details Up to 18 patients with chronic (> 4 weeks) neuropathic ulcers who give consent will have cells cultured from a healthy donor site. Cells will be incorporated into the dressing and applied each week for 6 weeks
Participating centres
  • Northern General Hospital, Sheffield

  • Sheffield Hallamshire Hospital

  • Nottingham City Hospital

  • The General Infirmary at Leeds

Lead unit CellTran Ltd
Principal investigator Professor Sheila MacNeil, University of Sheffield
Trial co-ordinator Dr Manar Moustafa
Time line
  • Recruitment planned from November 2003

  • Study completion planned in 12 months

Current situation Awaiting final agreement on documentation

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