Characterisation of a decellularised allograft dermis scaffold
Research type
Research Study
Full title
Characterisation of a decellularised allograft dermis scaffold for wound care and other applications.
IRAS ID
180031
Contact name
Christine Rowley
Contact email
Sponsor organisation
Tissue Regenix
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Tissue Regenix is a medical device company developing decellularised biological scaffolds for the repair/replacement of diseased or damaged tissues. The company uses their patented dCELL® process to remove cells from tissue, leaving a collagen scaffold that can be implanted, without the risk of rejection as it is not recognised as foreign. The patients' own cells are then able to infiltrate and remodel the scaffold.
Tissue Regenix has already launched, in the US, a decellularised human dermis product for the repair and replacement of integumental tissue (DermaPure®), such as wound healing in diabetic foot ulcers. Better use of donated human skin could be achieved by processing different thicknesses of skin for different purposes. This application seeks permission to further develop the decellularisation procedures used on full and split thickness human dermis and characterise and compare the functional, biochemical and biomechanical properties of decellularised human dermis with unprocessed tissue. By verifying the processing procedures for decellularised human dermis, a wider range of patients may be treated for a wider range of medical problems, including surgical augmentation (e.g. reinforce tenuous tendon repairs) and periodontal applications.
In order to verify successful decellularisation in the tissues, compare decellularised tissue with unprocessed tissue and characterise the resultant product, several properties need to be assessed including:
• Decellularisation – verify the tissue is clear from cells and DNA and that the collagen scaffold has not been damaged using histological and biochemical techniques as well as DNA quantification
• Biomechanical properties – verify that the tensile, burst and suture retention strength of the tissue is maintained
• Biocompatibility of the tissue – verify that the final product is biocompatible (i.e. would not cause a local or systemic reaction within the patient)
• Tissue structure - use methods such as immunohistochemistry and scanning electron microscopy to verify that certain structures within the tissue have been maintained (e.g. basement membrane)REC name
West of Scotland REC 5
REC reference
15/WS/0091
Date of REC Opinion
7 May 2015
REC opinion
Favourable Opinion