Systemic Sclerosis Clinical Trial
Official title:
EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
This prospective single-center study evaluates a current care procedure. It includes 14
patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger
criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their
face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale
0-48), a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth
opening less than 55 millimeters. They should not have anticoagulant, anti-platelets
aggregation medication or a daily steroid dose upper 20mg per day. Their BMI should exceed
17.
Micro fat grafting is a minimally invasive and usual procedure performed under local
anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm
diameter cannula from areas around the knees, the abdomen or the hips under a gentle
aspiration. Lipoaspirated fat is then filtrated by the PureGraft system that offers a
sterile, closed, single-use system, leading to a fast, consistent and controlled
preparation. Then, 10 to 25 milliliters of this purified fat product is transferred through
a 21 gauge or 0.8 mm diameter cannula in two or four points of the face, with the entry
points located around the mouth.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label
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