Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up.
OBJECTIVE
Impaired hand function greatly contributes to disability and reduced quality of life in SSc patients. Autologous adipose-derived stromal vascular fraction (ADSVF) is recognized as an easily accessible source of regenerative cells. We reported positive 6-month safety and efficacy results from an open-label clinical trial assessing s.c. injection of autologous ADSVF into the fingers in SSc patients. The objective of this report is to describe the effects at 12 months.


METHODS
Twelve females, mean age 54.5 years (s.d. 10.3), were assessed 1 year after ADSVF injection. Patients were eligible if they had a Cochin Hand Function Scale score >20/90. ADSVF was obtained from lipoaspirate using an automated processing system and subsequently injected into the s.c. tissue of each finger in contact with neurovascular pedicles in a one-time procedure. Endpoints were changes in hand disability and skin fibrosis, vascular manifestations, pain and quality of life at the 12 month follow-up. During the visit, patients estimated the benefit of the procedure with a specific self-completed questionnaire.


RESULTS
A significant decrease from baseline of 51.3% (P < 0.001) for Cochin Hand Function Scale score, 63.2% (P < 0.001) for RP severity and 46.8% (P = 0.001) for quality of life (Scleroderma Health Assessment Questionnaire) was observed. A significant improvement of finger oedema, skin sclerosis, motion and strength of the hands and of the vascular suppression score was also noted. The reduction in hand pain approached statistical significance (P = 0.052). The questionnaire revealed a benefit in daily activities, housework and social activities.


CONCLUSIONS
ADSVF injection is a promising therapy and appears to have benefits that extend for at least 1 year.
Internal Medicine Department and.
Perrine
P
Guillaume-Jugnot
Internal Medicine Department and.
Aurélie
A
Daumas
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance Publique Hôpitaux de Marseilles, Aix-Marseilles University.
Jérémy
J
Magalon
Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques, Assistance Publique Hôpitaux de Marseilles.
Elisabeth
E
Jouve
Plastic Surgery Department.
Pierre-Sébastien
PS
Nguyen
Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques, Assistance Publique Hôpitaux de Marseilles.
Romain
R
Truillet
Department of Dermatology and.
Stéphanie
S
Mallet
Plastic Surgery Department.
Dominique
D
Casanova
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance Publique Hôpitaux de Marseilles, Aix-Marseilles University.
Laurent
L
Giraudo
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance Publique Hôpitaux de Marseilles, Aix-Marseilles University.
Julie
J
Veran
Hematology and Vascular Biology Laboratory, Assistance Publique Hôpitaux de Marseilles and Vascular Research Center Marseille, INSERM UMRS-1076, Aix-Marseilles University, Marseilles, France.
Françoise
F
Dignat-George
Culture and Cell Therapy Laboratory, INSERM CBT-1409, Assistance Publique Hôpitaux de Marseilles, Aix-Marseilles University, Hematology and Vascular Biology Laboratory, Assistance Publique Hôpitaux de Marseilles and Vascular Research Center Marseille, INSERM UMRS-1076, Aix-Marseilles University, Marseilles, France.
Florence
F
Sabatier
Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques, Assistance Publique Hôpitaux de Marseilles, Plastic Surgery Department.
Guy
G
Magalon
Internal Medicine Department and Vascular Research Center Marseille, INSERM UMRS-1076, Aix-Marseilles University, Marseilles, France bgranel@ap-hm.fr.
Brigitte
B
Granel
D000273:Adipose Tissue / Q000637:transplantation*; D000328:Adult; D000368:Aged; D005260:Female; D005385:Fingers; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D008875:Middle Aged; D011788:Quality of Life; D012595:Scleroderma, Systemic / Q000628:therapy*; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome
adipose tissue; cell therapy; hand; stromal vascular fraction; systemic sclerosis