Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
概览
- 阶段
- 早期 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Systemic Sclerosis
- 发起方
- Suk-Ho Moon
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Colchin Hand Function Scale
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population
详细描述
In patients with systemic sclerosis(scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. The investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.
研究者
Suk-Ho Moon
Assistant Professor
Seoul St. Mary's Hospital
入排标准
入选标准
- •age over 18 year old
- •Cochin Hand Function Scale (CHFS) \> 20/90
排除标准
- •new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment
- •new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up
- •clinical or radiological signs of digital infection
- •positive status for HIV
- •positive status for hepatitis B or C
- •positive status for human T-cell leukemia virus 1-2
- •positive status for syphilis
- •pregnancy
- •BMI less than 17kg/m2
结局指标
主要结局
Colchin Hand Function Scale
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
The Degree of Hand Edema (Right)
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
The Degree of Hand Edema (Left)
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
Kapandji Score (Ranging 0 to 10) - Dominant Hand
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Kapandji Score (Non-dominant Hand)
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values
Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
Raynaud's Condition Scale
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)
Hand Visual Analogue Scale
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
时间窗: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)
次要结局
- Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)(Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
- Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)(Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
- Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)(Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
- Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)(Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
- Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)(Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
- Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)(Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)