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



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.



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.



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.
Internal Medicine Department, Assistance publique-Hôpitaux de Marseille (AP-HM), CHU of Marseille, 13915 Marseille, France.
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Daumas
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.
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Magalon
Centre d'investigation clinique - centre de pharmacologie clinique et d'évaluations thérapeutiques (CIC-CPCET), AP-HM, CHU of Marseille, 13005 Marseille, France.
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Jouve
Centre d'investigation clinique - centre de pharmacologie clinique et d'évaluations thérapeutiques (CIC-CPCET), AP-HM, CHU of Marseille, 13005 Marseille, France.
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Truillet
Plastic Surgery Department, AP-HM, CHU of Marseille, 13005 Marseille, France.
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Casanova
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance publique-Hôpitaux de Marseille (AP-HM), 13005 Aix Marseille University, France.
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Giraudo
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance publique-Hôpitaux de Marseille (AP-HM), 13005 Aix Marseille University, France.
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Veran
Internal Medicine Department, Assistance publique-Hôpitaux de Marseille (AP-HM), CHU of Marseille, 13915 Marseille, France.
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Benyamine
Hematology and Vascular Biology Laboratory, AP-HM, CHU of Marseille, 13005 Marseille, France; Inserm, VRCM, UMR_S 1076, Aix Marseille University, 13005 Marseille, France.
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Dignat-George
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.
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Magalon
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.
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Sabatier
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.
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Granel
D000273:Adipose Tissue / Q000166:cytology*; D000328:Adult; D000368:Aged; D002458:Cell Fractionation; D042783:Endothelial Cells / Q000166:cytology / Q000637:transplantation; D005260:Female; D005385:Fingers / Q000473:pathology; D005500:Follow-Up Studies; D006225:Hand; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011928:Raynaud Disease / Q000209:etiology / Q000628:therapy*; D012595:Scleroderma, Systemic / Q000150:complications / Q000628:therapy*; D012883:Skin Ulcer / Q000209:etiology / Q000628:therapy; D017154:Stromal Cells / Q000637:transplantation*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
Adipose tissue; Stromal vascular fraction; Systemic sclerosis