ADMSCs for the Treatment of Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- Biological: injection of autologous stromal vascular fraction
- Registration Number
- NCT02975960
- Lead Sponsor
- The Catholic University of Korea
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis.
- The skin lesion was not improved after 6 months treatment with conventional therapy.
- Pregnancy
- Start new medications within 3 months prior to enrollment
- Previous sympathectomy or amputation
- Current systemic infection
- AIDS, Syphilis, hepatitis B&C
- BMI <17kg/m2
- Cognitive dysfunction and other psychologic problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stromal vascular fraction injection injection of autologous stromal vascular fraction Injection of autologous stromal vascular fraction on hand.
- Primary Outcome Measures
Name Time Method Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks baseline, 12 weeks Assess hands mRSS
- Secondary Outcome Measures
Name Time Method 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 Kapandji score at 12weeks baseline, 12 weeks assess the mobility of both hands
Change from baseline Cochin hand function scale at 12 weeks baseline, 12 weeks Assess hand function (patients reported outcome)
Change from baseline peripheral vasculature at 12 weeks baseline, 12 weeks Assess peripheral vascularity by Nailfold capillaroscopy
Changes from baseline mRSS (total) at 12 weeks baseline, 12 weeks Assess total mRSS (including hands)
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
Change from baseline Systemic sclerosis HAQ at 12 weeks baseline, 12 weeks he quality of life- score adapted to systemic sclerosis
Change from baseline finger circumference at 12 weeks baseline, 12 weeks Measure second to fifth finger circumference
Trial Locations
- Locations (1)
Seoul St. Mary's hospital
🇰🇷Seoul, Korea, Republic of