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

Not Applicable

• Conditions: Systemic Sclerosis
• Interventions: Other: Micro reinjection of autologus adipose tissue

• Registration Number: NCT02206672
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-01
• Status Verified: 2015-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micro reinjection of autologus adipose tissue	Micro reinjection of autologus adipose tissue	-

Primary Outcome Measures

Name	Time	Method
improvement of the MHISS score	12 months	The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France