BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA

NCT ID: NCT03629002

Last Updated: 2018-08-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Scleroderma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

qPCR analysis

Interventions

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Study of the gene expression profile

qPCR analysis

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Patients with systemic scleroderma:

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Central Contacts

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Jérémy MAGALON

Role: CONTACT

Alexandra GIULIANI

Role: CONTACT

04 91 38 27 47

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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