Clinical trial NCT03629002: BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA
Official title: BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Scleroderma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic scleroderma included in the SCLERADEC 2 trial and healthy volunteers who use a liposuction operation for aesthetic reasons.

Brief summary: The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.

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.


Eligibility criteria: Inclusion Criteria:

Patients with systemic scleroderma:

* fulfilling the inclusion criteria for the SCLERADEC 2 trial: patients with systemic Scleroderma older than 18, desiring a therapeutic alternative and having a functional impotence authenticated by a functional index of Cochin's hand greater than 20.
* 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:

Patients with systemic scleroderma:

* 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

Primary outcomes:
measure: Study of the gene expression profile
timeFrame: 18 months
Secondary outcomes:
measure: Phenotypic analysis of the cells composing the stromal vascular fraction
timeFrame: 18 months
measure: Cell culture of the stromal vascular fraction to isolate and expand two populations of interest
timeFrame: 18 months
measure: Cell culture of the stromal vascular fraction to isolate and expand two populations of interest
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Direction de la Recherche Clinique et Innovation
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References: