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Clinical Trial
. 2015 Dec;74(12):2175-82.
doi: 10.1136/annrheumdis-2014-205681. Epub 2014 Aug 11.

Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial

Brigitte Granel  1 , Aurélie Daumas  2 , Elisabeth Jouve  3 , Jean-Robert Harlé  2 , Pierre-Sébastien Nguyen  4 , Christian Chabannon  5 , Nathalie Colavolpe  6 , Jean-Charles Reynier  7 , Romain Truillet  3 , Stéphanie Mallet  8 , Antoine Baiada  4 , Dominique Casanova  4 , Laurent Giraudo  9 , Laurent Arnaud  10 , Julie Veran  9 , Florence Sabatier  11 , Guy Magalon  12
Affiliations
Clinical Trial

Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial

Brigitte Granel et al. Ann Rheum Dis. 2015 Dec.

Abstract

Background: In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.

Methods: We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy.

Findings: All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed.

Interpretation: This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population.

Funding: GFRS (Groupe Francophone de Recherche sur la Sclérodermie).

Clinical trials number: NCT01813279.

Keywords: Autoimmune Diseases; Systemic Sclerosis; Treatment.

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Figures

Figure 1
Figure 1
Six-month follow-up for patients with systemic sclerosis receiving stromal vascular fraction injection (p<0.05 at M2 and M6).
See this image and copyright information in PMC

References

    1. Guillevin L, Hunsche E, Denton CP, et al. ; DUO Registry Group. Functional impairment of systemic scleroderma patients with digital ulcerations: results from the DUO Registry. Clin Exp Rheumatol 2013;31:71–80. - PubMed
    1. Hachulla E, Clerson P, Launay D, et al. Natural history of ischemic digital ulcers in systemic sclerosis: single-center retrospective longitudinal study. J Rheumatol 2007;34:2423–30. - PubMed
    1. Sandqvist G, Eklund M. Hand Mobility in Scleroderma (HAMIS) test: the reliability of a novel hand function test. Arthritis Care Res 2000;13:369–74. - PubMed
    1. Avouac J, Guerini H, Wipff J, et al. Radiological hand involvement in systemic sclerosis. Ann Rheum Dis 2006;65:1088–92. - PMC - PubMed
    1. Kowal-Bielecka O, Landewé R, Avouac J, et al. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis 2009;68:620–8. - PubMed

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