Research 4

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 patient’s 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 patient’s 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

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 patient’s own keratinocytes onto a transfer dressing