Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis
2 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
3 CIC - Centre d'Investigation Clinique [Hôpital de la Conception - APHM]
4 Hôpital Nord [CHU - APHM]
5 APHM - Assistance Publique - Hôpitaux de Marseille
6 CHU Rouen
7 PANTHER - Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices
8 AP-HP - Hopital Saint-Louis [AP-HP]
9 URP_3518 - Recherche clinique appliquée à l'hématologie
10 McGill University = Université McGill [Montréal, Canada]
11 Service de Médecine Interne [CHU Rouen]
12 EnVI - Endothélium, valvulopathies et insuffisance cardiaque
13 CRCM - Centre de Recherche en Cancérologie de Marseille
14 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
15 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
16 HIPI (UMR_S_976 / U976) - Immunologie humaine, physiopathologie & immunothérapie
17 Hôpital privé Jean Mermoz [Lyon]
18 Hôpital Edouard Herriot [CHU - HCL]
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Résumé
Objective: To assess the superiority of adipose tissue-derived stromal vascular fraction (AD-SVF) injection into the fingers vs placebo in reducing hand disability in systemic sclerosis (SSc) patients. Methods: We performed a double-blind, multicentre, phase II trial from October 2015 to January 2018 in France. SSc patients with a Cochin Hand Function Scale (CHFS) ≥20/90 were randomized 1:1 to receive injection of AD-SVF or placebo. AD-SVF was obtained using the automated processing Celution®800/CRS system. The placebo was lactated Ringer's solution. The primary efficacy end point was the change of the CHFS score from baseline to 3 months. Secondary efficacy endpoints included the CHFS score at 6 months, hands function, vasculopathy, hands pain, skin fibrosis, sensitivity of the finger' pulps, Scleroderma Health Assessment Questionnaire, patients and physician satisfaction and the safety. Results: 40 patients were randomized. The AD-SVF and placebo groups were comparable for age, sex ratio, disease duration, skin fibrosis of the hands and main cause of hand disability. After 3 month-follow-up, hand function significantly improved in both groups with no between-group difference of CHFS (mean change of -9.2 ± 12.2 in the AD-SVF group vs -7.6 ± 13.2 in the placebo group). At 6 months, hand function improved in both groups. Conclusion: This study showed an improvement of hand function in both groups other time, with no superiority of the AD-SVF. Considering the limits of this trial, studies on a larger population of patients with homogeneous phenotype and hand handicap, should be encouraged to accurately assess the benefit of AD-SVF therapy.