Evaluation of Fat Grafting and Systemic Sclerosis

  • Research type

    Research Study

  • Full title

    Evaluation of Fat Grafting in the treatment of facial Systemic Sclerosis

  • IRAS ID

    196386

  • Contact name

    Peter Butler

  • Contact email

    peter.butler1@nhs.net

  • Sponsor organisation

    University College London

  • Clinicaltrials.gov Identifier

    No Z6364106/2016/01/45 clinical research, UCL Data Protection Registration

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Around 12,000 people in the UK have been diagnosed with scleroderma, with women affected four times as often as men. It is an autoimmune condition, involving the overproduction of collagen and blood vessel damage. Excess collagen is laid down in the skin, which in turn results in skin fibrosis and reduced normal function. In particular, soft tissue fibrosis and skin hardening can impair facial movement and mouth opening. The microstomia can be a stigma for this patients, causing not only aesthetic-related concerns, but also difficulty in chewing, and in oral hygiene .
    In the last decade, adipose tissue transfer has been introduced in the treatment of several fibrotic conditions, including radiation­ induced fibrosis, lichen sclerosus and scleroderma. Remarkable improvements in both function and quality of fibrotic skin have been reported following lipotransfer. However, existing clinical research is limited by a lack of experimental data that quantifies the outcome. Studies draw conclusions based on subjective, imprecise outcome measures, making statistical evaluation difficult and potentially introducing bias.
    In this study we are aiming to monitor the systemic sclerosis patients receiving fat transfer treatment with Prof Peter Butler (the surgery aspect is not part of the research study).
    Patients who have undergone lipotransfer at Royal Free Hospital will be followed up using questionnaires.
    The data accumulated from this study will enable us to better understand how fibrotic skin changes in response to lipotransfer. This data will then be useful in establishing robust evidence for the efficacy of lipotransfer treatment.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    16/SC/0669

  • Date of REC Opinion

    4 Jan 2017

  • REC opinion

    Further Information Favourable Opinion