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Curr Res Transl Med. 2017 Jan - Mar;65(1):40-43. doi: 10.1016/j.retram.2016.10.006. Epub 2016 Nov 28.

Long-term follow-up after autologous adipose-derived stromal vascular fraction injection into fingers in systemic sclerosis patients.

Author information

1
Internal Medicine Department, Assistance publique-Hôpitaux de Marseille (AP-HM), CHU of Marseille, 13915 Marseille, France.
2
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance publique-Hôpitaux de Marseille (AP-HM), 13005 Aix Marseille University, France; Inserm, VRCM, UMR_S 1076, Aix Marseille University, 13005 Marseille, France.
3
Centre d'investigation clinique - centre de pharmacologie clinique et d'évaluations thérapeutiques (CIC-CPCET), AP-HM, CHU of Marseille, 13005 Marseille, France.
4
Plastic Surgery Department, AP-HM, CHU of Marseille, 13005 Marseille, France.
5
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance publique-Hôpitaux de Marseille (AP-HM), 13005 Aix Marseille University, France.
6
Hematology and Vascular Biology Laboratory, AP-HM, CHU of Marseille, 13005 Marseille, France; Inserm, VRCM, UMR_S 1076, Aix Marseille University, 13005 Marseille, France.
7
Centre d'investigation clinique - centre de pharmacologie clinique et d'évaluations thérapeutiques (CIC-CPCET), AP-HM, CHU of Marseille, 13005 Marseille, France; Plastic Surgery Department, AP-HM, CHU of Marseille, 13005 Marseille, France.
8
Internal Medicine Department, Assistance publique-Hôpitaux de Marseille (AP-HM), CHU of Marseille, 13915 Marseille, France; Inserm, VRCM, UMR_S 1076, Aix Marseille University, 13005 Marseille, France. Electronic address: bgranel@ap-hm.fr.

Abstract

INTRODUCTION:

Hand involvement confers a substantial handicap in work and daily activities in patients with Systemic sclerosis (SSc). Autologous adipose-derived stromal vascular fraction is as an easily accessible source of cells with regenerative effects. We previously performed a phase I open-label clinical trial (NTC01813279) assessing the safety of subcutaneous injection of autologous adipose-derived stromal vascular fraction. Six and 12-month data have been reported. As patients were followed in our medical centre, we report their longer-term outcome beyond the end of the trial.

PATIENTS AND METHOD:

Twelve females, mean age 54.5±10.3 years, initially enrolled in the clinical trial were assessed during a scheduled medical care, which took place between 22 and 30months after treatment.

RESULTS:

Multiple patient-reported outcomes showed sustained improvement, in comparison with the assessment performed just before surgery: 62.5% in the Cochin Hand Function Scale, 51.1% in the Scleroderma Health Assessment Questionnaire, 33.1% in hand pain, and 88.3% in the Raynaud Condition Score. A decrease in the number of digital ulcers number was noted. Mobility, strength and fibrosis of the hand also showed improvement. None of the 8 patients who had previously received iloprost infusion required new infusion.

CONCLUSION:

Despite the limits of an open label study, the data are in favour of the long-term safety of the adipose-derived stromal vascular fraction injection. Two randomized double blind, placebo-controlled trials of this therapeutic agent are ongoing in the USA (NCT02396238) and in France (NCT02558543) and will help determine the place of this innovative therapy for SSc patients.

KEYWORDS:

Adipose tissue; Stromal vascular fraction; Systemic sclerosis

PMID:
28340695
DOI:
10.1016/j.retram.2016.10.006
[Indexed for MEDLINE]

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