Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy Assessment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 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.
. 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.
A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of twelve patients to be proven.
The encouraging results have encouraged us to propose a trial which would bear on a higher number of patients and include a control group.
详细描述
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.
A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of twelve patients to be proven. Secondary efficacy endpoints evaluated at 2 months (M2) and 6 months (M6) showed an improvement in disability, pain, severity of Raynaud's phenomenon, trophicity, the number of digital ulcers, hand mobility and in the quality of life. These encouraging results have encouraged the investigators to propose a trial which would bear on a higher number of patients and include a 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Stromal Vascular Fraction
The injection is made for the patients of the both groups in the sub-dermic plan on the side faces of fingers distal and proximal or 4 times 0,25ml by finger, all in all every finger will be injected of 1ml of diluted Stromal Vascular Fraction ( experimental group) , or placebo (ringer lactate) ( placebo group)
干预措施: Stromal Vascular fraction (Drug)
Placebo
The injection is made for the patients of the both groups in the sub-dermic plan on the side faces of fingers distal and proximal or 4 times 0,25ml by finger, all in all every finger will be injected of 1ml of diluted Stromal Vascular Fraction ( experimental group) , or placebo ( placebo group)
干预措施: Ringer lactate (Drug)
结局指标
主要结局
Cochin hand functional scale
时间窗: 3 months
effects of SVF injections in the fingers of patients suffering from SSc evaluated at 3 months, in comparison to the control group
次要结局
- the vascular suppression score(6 months)
- the pain in the hands (EVA pain scale),(6 months)
- the strength(Jamar et Pinch test)(6 months)
- the quality of life- score adapted to scleroderma (SHAQ)(6 months)
- the mobility(score de Kapandji et distance pulpe/pli palmaire distal)(6 months)
- the finger tactile sensitivity(6 months)
- the trouble trophicity (health assesment questionnaire)(6 months)
- the severity (frequency and intensity of crises) of Raynaud's phenomenon(6 months)