Systemic Sclerosis
Conditions
Keywords
systemic sclerosis, adipose derived stem cell, stromal vascular fraction, digital ulcer, gangrene
Brief summary
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.
Detailed description
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
Interventions
BIOLOGICALinjection of autologous stromal vascular fraction
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.
Sponsors
Seoul St. Mary's Hospital
The Catholic University of Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis. 2. The skin lesion was not improved after 6 months treatment with conventional therapy.
Exclusion criteria
1. Pregnancy 2. Start new medications within 3 months prior to enrollment 3. Previous sympathectomy or amputation 4. Current systemic infection 5. AIDS, Syphilis, hepatitis B&C 6. BMI \<17kg/m2 7. Cognitive dysfunction and other psychologic problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks | baseline, 12 weeks | Assess hands mRSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Visual Analog Score for pain the hands at 12 weeks | baseline, 12 weeks | Patient report hand pain degree, comparing baseline and 12 weeks |
| Changes from baseline mRSS (total) at 12 weeks | baseline, 12 weeks | Assess total mRSS (including hands) |
| Change from baseline Kapandji score at 12weeks | baseline, 12 weeks | assess the mobility of both hands |
| Change from baseline Raynaud's condition score at 12 weeks | baseline, 12 weeks | The severity (frequency and intensity of crises) of Raynaud's phenomenon |
| Change from baseline Systemic sclerosis HAQ at 12 weeks | baseline, 12 weeks | he quality of life- score adapted to systemic sclerosis |
| Change from baseline peripheral vasculature at 12 weeks | baseline, 12 weeks | Assess peripheral vascularity by Nailfold capillaroscopy |
| Change from baseline finger circumference at 12 weeks | baseline, 12 weeks | Measure second to fifth finger circumference |
| Change from baseline Cochin hand function scale at 12 weeks | baseline, 12 weeks | Assess hand function (patients reported outcome) |
Countries
South Korea
Outcome results
None listed