Feasibility Study of Stem-cell Enriched Autologous Lipotransfer to Treat Oro-facial Fibrosis in Systemic Sclerosis (Sys-Stem): Protocol for Open-label Randomised Controlled Trial

Overview

Journal Int J Surg Protoc

Specialty General Surgery

Date 2020 Aug 18

PMID 32803023

Citations 1

Authors

Faith Hyun Kyung Jeon

Michelle Griffin

Christopher Paul Denton

Peter Edward Michael Butler

Affiliations

Soon will be listed here.

Abstract

Introduction: Oro-facial fibrosis is a common and disabling manifestation of systemic sclerosis (SSc), causing a plethora of functional, aesthetic and social compromise, yet is without effective treatment. Autologous lipotransfer is an established minimally invasive surgical procedure that is postulated to exert anti-fibrotic effects by adipose-derived stem cells, and presents a novel method in the treatment of fibrotic conditions. This study aims to assess the safety and efficacy of autologous lipotransfer for facial involvement in SSc.

Methods And Analysis: This is the first randomised controlled study with an open label design to assess autologous lipotransfer for oro-facial involvement in systemic sclerosis. The goals of this study are to assess the feasibility of using a range of quantitative and qualitative outcome measures to effectively measure disease severity and treatment outcome, and to assess patient acceptability for future multi-centre trials. A total of 50 participants will be randomised to a treatment or control group. The treatment group will receive autologous fat transfer to the peri-oral region by a single surgeon. Dermal fibroblasts and adipose-derived stem cells will be isolated from tissue samples. All outcome measures will be taken at baseline, then at 6 weeks, 3 months and 6 months from the time of intervention in the treatment arm, or from baseline in the control arm.

Ethics And Dissemination: The study has ethical approval (REC reference 19/LO/0718). Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.

Trial Registration: Registered on ISRCTN registry (ISRCTN17793055).

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