Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the treatment for these manifestations are often ineffective. Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc. There are only few ways to manage SSc patients with skin lesion who already have treated with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist) but some times their skin lesions are critical physically and emotionally. Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc. Thus, the investigators study the efficacy and potential adverse event in Korean patients with SSc.
In this study, the investigators will inject autologous Stromal vascular fraction. 1\) Acquiring autologous stromal vascular fraction by plastic surgeon 1. Liposuction 2. Extraction and purifying SVF using Smart-X system (15-20 min) 3. Making syringe filled with autologous SVF 2\) SVF injection Inject SVF subcutaneously with 25G needle in finger
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
1. Acquiring autologous stromal vascular fraction (SVF) from liposuction 2. purifying SVF from lipoaspirates and making syringe filled with SVF 3. SVF injection - Inject SVF on fingers subcutaneously.
Seoul St. Mary's hospital
Seoul, South Korea
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
Assess hands mRSS
Time frame: baseline, 12 weeks
Change from baseline Raynaud's condition score at 12 weeks
The severity (frequency and intensity of crises) of Raynaud's phenomenon
Time frame: baseline, 12 weeks
Change from baseline Visual Analog Score for pain the hands at 12 weeks
Patient report hand pain degree, comparing baseline and 12 weeks
Time frame: baseline, 12 weeks
Changes from baseline mRSS (total) at 12 weeks
Assess total mRSS (including hands)
Time frame: baseline, 12 weeks
Change from baseline Kapandji score at 12weeks
assess the mobility of both hands
Time frame: baseline, 12 weeks
Change from baseline Cochin hand function scale at 12 weeks
Assess hand function (patients reported outcome)
Time frame: baseline, 12 weeks
Change from baseline Systemic sclerosis HAQ at 12 weeks
he quality of life- score adapted to systemic sclerosis
Time frame: baseline, 12 weeks
Change from baseline peripheral vasculature at 12 weeks
Assess peripheral vascularity by Nailfold capillaroscopy
Time frame: baseline, 12 weeks
Change from baseline finger circumference at 12 weeks
Measure second to fifth finger circumference
Time frame: baseline, 12 weeks
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