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

NCT03629002 | Unknown

• 2 other identifiers: 2018-06IDRCB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Scleroderma

Outcome Measures

Primary Outcomes (1)

• Study of the gene expression profile

  Study of the gene expression profile by qPCR

  18 months

Secondary Outcomes (3)

• Phenotypic analysis of the cells composing the stromal vascular fraction

  18 months

• Cell culture of the stromal vascular fraction to isolate and expand two populations of interest

  18 months

• Cell culture of the stromal vascular fraction to isolate and expand two populations of interest

  18 months

Study Arms (2)

patients with systemic scleroderma

Use of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial.

Biological: Study of the gene expression profile

healthy volunteers

Recovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery.

Biological: Study of the gene expression profile

Interventions

Study of the gene expression profile BIOLOGICAL

qPCR analysis

healthy volunteers; patients with systemic scleroderma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Direction de la Recherche Clinique et Innovation

Marseille, 13005, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stromal vascular fraction obtained from adipose tissue.

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique des Hopitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Jérémy MAGALON

CONTACT

jeremy.magalon@ap-hm.fr

Alexandra GIULIANI

CONTACT

04 91 38 27 47; drci@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

FR (1)