Systemic Sclerosis Clinical Trial
Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an
alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are
frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a
result, patients suffer from everyday disability, with consequences on their occupational
activities and social contact, sometimes severely altering their quality of life. To date,
no anti-fibrosis treatment has proven effective; existing vasodilation treatments are
unfortunately not very effective, and are associated with adverse effects or restrictions.
It is consequently of utmost importance that an effective treatment for sclerodermic hands
be developed. The injection of adipose autologous tissue is a common practice in plastic
surgery, and has been known for over a century. Adipose tissue, originally used to increase
volume, is also characterized by trophic properties associated to stromal vascular fraction
(SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some
SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.
The injection of SVF into the fingers would also make it possible to control the production
of the extracellular matrix and to improve the balance between fibrosis and fibrolysis,
resulting in an improvement of cutaneous sclerosis
The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients
suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison
to the control group.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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