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

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ClinicalTrials.gov Identifier: NCT03629002
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment
Systemic Scleroderma Biological: Study of the gene expression profile

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020


Group/Cohort Intervention/treatment
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
qPCR analysis

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
qPCR analysis




Primary Outcome Measures :
  1. Study of the gene expression profile [ Time Frame: 18 months ]
    Study of the gene expression profile by qPCR


Secondary Outcome Measures :
  1. Phenotypic analysis of the cells composing the stromal vascular fraction [ Time Frame: 18 months ]
    Phenotypic analysis performed by flow cytometry after multiple immunolabelings (CD90, CD14, CD146, CD34, CD45, DRAQ5, NucBlue Fixed Cell Stain (DAPI)) performed in accordance with the recommendations of the International Society for Cellular Therapy (ISCT) and IFATS.

  2. Cell culture of the stromal vascular fraction to isolate and expand two populations of interest [ Time Frame: 18 months ]
    Mesenchymal stem cells (MSCs) obtained by culturing the total stromal vascular fraction without an immunomagnetic selection step.

  3. Cell culture of the stromal vascular fraction to isolate and expand two populations of interest [ Time Frame: 18 months ]
    Endothelial progenitors by a magnetic immuno-separation method (CD144 microbeads kit, Mylteni biotec) for specifically isolating and expanding endothelial progenitor cells.


Biospecimen Retention:   Samples Without DNA
Stromal vascular fraction obtained from adipose tissue.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629002


Contacts
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Contact: Jérémy MAGALON jeremy.magalon@ap-hm.fr
Contact: Alexandra GIULIANI 04 91 38 27 47 drci@ap-hm.fr

Locations
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France
Direction de la Recherche Clinique et Innovation
Marseille, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD Assistance Publique des Hopitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03629002     History of Changes
Other Study ID Numbers: 2018-06
IDRCB ( Other Identifier: 2018-A00150-55 )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases