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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Systemic Scleroderma

Treatments

Biological: Study of the gene expression profile

Study type

Observational

Funder types

Other

Identifiers

NCT03629002
2018-06
IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

patients with systemic scleroderma
Description:
Use of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial.
Treatment:
Biological: Study of the gene expression profile
healthy volunteers
Description:
Recovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery.
Treatment:
Biological: Study of the gene expression profile

Trial contacts and locations

1

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Central trial contact

Jérémy MAGALON; Alexandra GIULIANI

Data sourced from clinicaltrials.gov

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