Clinical trial NCT02206672: EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
Official title: EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: improvement of the MHISS score
timeFrame: 12 months
Secondary outcomes:
measure: evaluate the effect of the procedure on quality of life
timeFrame: 12 months
measure: evaluate the effect of the procedure on face pain
timeFrame: 12 months
measure: evaluate the effect of the procedure on skin fibrosis
timeFrame: 12 months
measure: evaluate the effect of the procedure on physical face changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: AP HM
name: brigitte GRANEL, MD
role: PRINCIPAL_INVESTIGATOR
References: