Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT03629002
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03629002
Study Brief:
Protocol Section:
NCT03629002