Systemic SclerosisFACENCT02206672
EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
A study testing Micro reinjection of autologus adipose tissue in people with Systemic Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Micro reinjection of autologus adipose tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Severe infection.
- Inmates.
- Pregnant women.
- Adults protected by law (under guardianship and trusteeship).
- No affiliation to a social security scheme.
Trial locations and contacts
1 site in 1 country.
brigitte GRANEL contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
BRIGITTE GRANEL, brigitte.granel@ap-hm.fr
brigitte GRANEL
About this study
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
- Being tested
- Micro reinjection of autologus adipose tissue
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro reinjection of autologus adipose tissueOther
| Study group | Role | What they receive |
|---|---|---|
| Micro reinjection of autologus adipose tissue | Other | Not described Receives: Other: Micro reinjection of autologus adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of the MHISS score
The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.
Measured: 12 months
Secondary outcomes (4)
evaluate the effect of the procedure on quality of life
Health Assessment Questionnaire adapted to scleroderma, SHAQ
Measured: 12 months
evaluate the effect of the procedure on face pain
face pain scale (VAS 0-100)
Measured: 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)
Measured: 12 months
evaluate the effect of the procedure on physical face changes
physical face changes is evaluated by standard and 3D photographs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- brigitte GRANEL, MD, Principal investigator, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206672
- Sponsor's protocol ID
- 2014-A01014-43
- Other IDs
- 2014-12
- Acronym
- FACE
- Status last verified
- Sep 2015
- First submitted
- 31 Jul 2014
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
- ClinicalTrials.gov ID
- NCT02206672
- Acronym / sponsor ID
- FACE / 2014-A01014-43
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro reinjection of autologus adipose tissue | Other | Other: Micro reinjection of autologus adipose tissue |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- Less than 18 or greater than 80 age.
- Decaying history of abdominal surgery.
- Body mass index lower than 18.
- Coagulation disorders.
- Allergy to Xylocaine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro reinjection of autologus adipose tissue | Other | Micro reinjection of autologus adipose tissue |
Primary outcome
improvement of the MHISS score
Time frame: 12 months
The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.
4 secondary outcomes
evaluate the effect of the procedure on quality of life
Time frame: 12 months
evaluate the effect of the procedure on face pain
Time frame: 12 months
evaluate the effect of the procedure on skin fibrosis
Time frame: 12 months
evaluate the effect of the procedure on physical face changes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
brigitte GRANEL contact
brigitte GRANEL, MD principal investigator
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro reinjection of autologus adipose tissue in people with Systemic Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact brigitte GRANEL (brigitte.granel@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of the MHISS score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.