BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA
NCT ID: NCT03629002
Last Updated: 2018-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2018-09-30
2020-09-30
Brief Summary
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The main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.
A total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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patients with systemic scleroderma
Use of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial.
Study of the gene expression profile
qPCR analysis
healthy volunteers
Recovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery.
Study of the gene expression profile
qPCR analysis
Interventions
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Study of the gene expression profile
qPCR analysis
Eligibility Criteria
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Inclusion Criteria
* having given their consent for the constitution of a sample in the biological collection
* having completed the follow-up visit to M3 of the SCLERADEC 2 study to have responder / non-responder status.
Healthy volunteers:
* having recourse to a liposuction operation for aesthetic reasons,
* with a BMI between 18 and 27,
* not declaring chronic diseases,
* having signed the non-opposition
Exclusion Criteria
* Body mass index (weight-to-height ratio squared) less than 18
* Major Sclerodactyly objectified by Rodnan score applied by hand\> 16 (out of a total of 18 points)
* Severe tendon retraction of the fingers objectified by a defect extension in passive measure in goniometry\> 90 ° C for at least 2 proximal interphalangeal joints
* Digital infection (including infected ulcer, ulcer with local inflammatory signs and clinical suspicion of osteitis)
* Pulmonary arterial hypertension and / or progressive and / or oxygen-dependent pulmonary fibrosis
* Prescription of a new systemic treatment for Systemic Scleroderma in the month prior to inclusion
* Persons infected with HIV, HCV, HBV, HTLV and syphilis
* Patients on immunosuppressants outside corticosteroid therapy \<10 mg / day and methotrexate
* Known hypersensitivity to human albumin
For healthy patients and volunteers:
* Contraindication to surgery (patients on anticoagulant or antiaggregant, disorders of haemostasis, contraindication to the analgesic protocol used)
* Premenopausal women of childbearing age without contraception
* Minors
* Pregnant or lactating women
* Majors protected by law (under tutorship or curatorship)
* Persons staying in a health or social facility
* People in emergency
* Persons deprived of their liberty
* Inmates
* Non-beneficiaries of a social security scheme
* Absence or refusal of non-opposition
18 Years
ALL
Yes
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Jean-Olivier ARNAUD
Role: STUDY_DIRECTOR
Assistance Publique des Hopitaux de Marseille
Locations
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Direction de la Recherche Clinique et Innovation
Marseille, , France
Countries
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Central Contacts
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Other Identifiers
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IDRCB
Identifier Type: OTHER
Identifier Source: secondary_id
2018-06
Identifier Type: -
Identifier Source: org_study_id
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