Sys-Stem
Research type
Research Study
Full title
Feasibility study of stem-cell enriched autologous lipotransfer to treat oro-facial fibrosis in systemic sclerosis (Sys-Stem)
IRAS ID
248134
Contact name
Peter Butler
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Systemic sclerosis/scleroderma (SSc) is a complex disease that involves fibrosis of the skin and internal organs. Fibrosis is similar to scarring after injury but is excessive and leads to tightening and hardening of the skin. Fibrosis of the face inhibits facial movement and impairs mouth function. Facial fibrosis greatly impacts the quality of life of patients and most often leads to problems with eating, speaking and dental care. We are pioneering a new treatment option for facial fibrosis in SSc. The surgical technique utilizes the patients' own fat stores to reconstruct facial tissue. Facial volume is enhanced but most strikingly the effects of facial fibrosis are reversed. This has had profound effects on the patient’s quality of life and has restored facial mobility and mouth function. These striking results need to be confirmed in a controlled multi-centre clinical trial. The first step is a feasibility study to inform important aspects of the design, which is what we propose here, a single site study that will take place in the Royal Free London NHS Foundation Trust. We have identified and prioritised the key research questions with the help of our dedicated Sys-Stem patient discussion group. The patient discussion group identified mouth function and appearance as being the most important research topic and this will be the focus of Sys-Stem. We will measure improvement in mouth opening and will test a range of methods to quantify and measure improvement in fibrosis of facial and oral tissue. We will also use self-report questionnaires to assess improvement in mouth function, appearance and quality of life. The results of this study will directly benefit patients and could lead to the development of new treatment option for systemic sclerosis and other fibrotic diseases.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/0957
Date of REC Opinion
7 Aug 2019
REC opinion
Further Information Favourable Opinion