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

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: Micro reinjection of autologus adipose tissue

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hôpitaux de Marseille
    • Contact: BRIGITTE GRANEL; Email: brigitte.granel@ap-hm.fr
    • Principal Investigator: brigitte GRANEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Micro reinjection of autologus adipose tissue	Other: Micro reinjection of autologus adipose tissue

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: brigitte GRANEL, MD, AP HM

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 2014-A01014-43; 2014-12 (Other Identifier: AP HM)