EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS

Study Overview
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Brief Summary
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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.

Official Title
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EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: Micro reinjection of autologus adipose tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 or younger than 80 years. Suffering from systemic scleroderma. Patient follow-AP-HM. Score of 20 or greater MHISS. Score Rodnan level greater than or equal to one face. Mouth opening (inter-incisor distance) <5.5 cm Wishing to receive surgery at the face. Exclusion Criteria: Less than 18 or greater than 80 age. Decaying history of abdominal surgery. Body mass index lower than 18. Coagulation disorders. Allergy to Xylocaine. Greater than 20mg / d steroids. Severe infection. Inmates. Pregnant women. Adults protected by law (under guardianship and trusteeship). No affiliation to a social security scheme.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Micro reinjection of autologus adipose tissue<br> | Other: Micro reinjection of autologus adipose tissue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of the MHISS score | The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the effect of the procedure on quality of life | Health Assessment Questionnaire adapted to scleroderma, SHAQ | 12 months | 
| evaluate the effect of the procedure on face pain | face pain scale (VAS 0-100) | 12 months | 
| evaluate the effect of the procedure on skin fibrosis | skin fibrosis is measured by Rodnan skin score for the face, mouth opening measure and cutometry) | 12 months | 
| evaluate the effect of the procedure on physical face changes | physical face changes is evaluated by standard and 3D photographs. | 12 months |