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
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Study of the gene expression profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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
- •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
- •Non-beneficiaries of a social security scheme
- •Absence or refusal of non-opposition
结局指标
主要结局
Study of the gene expression profile
时间窗: 18 months
Study of the gene expression profile by qPCR
次要结局
- Cell culture of the stromal vascular fraction to isolate and expand two populations of interest(18 months)
- Phenotypic analysis of the cells composing the stromal vascular fraction(18 months)