NCT02206672

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 5, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

July 31, 2014

Last Update Submit

November 4, 2015

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • evaluate the effect of the procedure on quality of life

    12 months

  • evaluate the effect of the procedure on face pain

    12 months

  • evaluate the effect of the procedure on skin fibrosis

    12 months

  • evaluate the effect of the procedure on physical face changes

    12 months

Study Arms (1)

Micro reinjection of autologus adipose tissue

OTHER
Other: Micro reinjection of autologus adipose tissue

Interventions

Micro reinjection of autologus adipose tissueOTHER
Micro reinjection of autologus adipose tissue

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • brigitte GRANEL, MD

    AP HM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

brigitte GRANEL

CONTACT

brigitte.granel@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 1, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-09

Locations

FR(1)