SCLERoderma et Adipose-DErived Stroma Cells
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cochin hand functional scale
研究概览
简要总结
Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a result, patients suffer from everyday disability, with consequences on their occupational activities and social contact, sometimes severely altering their quality of life. To date, no anti-fibrosis treatment has proven effective; existing vasodilation treatments are unfortunately not very effective, and are associated with adverse effects or restrictions. It is consequently of utmost importance that an effective treatment for sclerodermic hands be developed. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc. The injection of SVF into the fingers would also make it possible to control the production of the extracellular matrix and to improve the balance between fibrosis and fibrolysis, resulting in an improvement of cutaneous sclerosis
The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemic Sclerosis ( limited or diffuse cutaneous shape)
- •Men and women of more than 18 years old
- •Patients wishing for a therapeutic alternative
- •Functional Disability of the dominant hand authenticated by a functional index of the hand of Cochin functional scale upper to 20
排除标准
- •Body mass index (weight in kilograms divided by height in meters squared) lower than 18
- •Finger infection (including infected ulcer, ulcer with signs of local inflammation and clinical suspicion of osteitis)
- •Contraindication to surgery
- •Prescription of a new systemic treatment for SSc in the month before the inclusion Subjects infected with HIV, HCV ( hepatitis C virus) , HBV (hepatitis B virus), HTLV ( human T-cell leukemia virus) and syphilis
- •Pre-menopausal women of reproductive age, taking no contraceptive method
- •Patients receiving immunosuppressive therapy not including corticosteroid therapy < 10 mg/D and methotrexate
研究组 & 干预措施
PLACEBO
Patients will receive an injection of placebo
干预措施: Ringer lactate (Drug)
DRUG : Stromal Vascular Fraction
Patients will receive an injection of Stromal Vascular Fraction injection
干预措施: Stromal Vascular fraction (Drug)
结局指标
主要结局
Cochin hand functional scale
时间窗: 12 months
次要结局
- the severity (frequency and intensity of crises) of Raynaud's phenomenon(12 months)
- the strength (Jamar et Pinch test)(12 months)
- the trouble trophicity (health assesment questionnaire)(12months)
- the pain in the hands (EVA pain scale),(12 months)
