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

NCT ID: NCT02206672

Last Updated: 2015-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-11-30

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.

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Micro reinjection of autologus adipose tissue

Group Type: OTHER

Micro reinjection of autologus adipose tissue

Intervention Type: OTHER

Interventions

Micro reinjection of autologus adipose tissue

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

brigitte GRANEL, MD

Role: PRINCIPAL_INVESTIGATOR

AP HM

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

brigitte GRANEL

Role: CONTACT

brigitte.granel@ap-hm.fr

Facility Contacts

BRIGITTE GRANEL

Role: primary

brigitte.granel@ap-hm.fr

Other Identifiers

2014-12

Identifier Type: OTHER

Identifier Source: secondary_id

2014-A01014-43

Identifier Type: -

Identifier Source: org_study_id