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

Systemic Sclerosis Clinical Trial

— FACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02206672
• Other study ID #: 2014-A01014-43
• Secondary ID: 2014-12
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2014
• Last updated: November 4, 2015
• Start date: July 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: brigitte GRANEL
• Email: brigitte.granel[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Micro reinjection of autologus adipose tissue

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	evaluate the effect of the procedure on quality of life	Health Assessment Questionnaire adapted to scleroderma, SHAQ	12 months	No
Secondary	evaluate the effect of the procedure on face pain	face pain scale (VAS 0-100)	12 months	No
Secondary	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	No
Secondary	evaluate the effect of the procedure on physical face changes	physical face changes is evaluated by standard and 3D photographs.	12 months	No