Safety and efficacy of treatment of autologous adipose-derived stem cell in the systemic sclerosis patients
Not Applicable
Recruiting
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0003234
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients were eligible
1. if they were aged 18 or older
2. Patients show no more response or no progression to medical treatment (Calcium channel inhibitor, PDE4 inhibitor, endothelin receptor antagonist) and patients who have adverse effects to medical treatment.
Exclusion Criteria
Exclusion criteria
-new vasodilators or immunosuppressive therapy for systemic sclerosis in the 3 months prior to enrolment
-surgical contraindication
- clinical or radiological signs of digital infection
-positive status for HIV, hepatitis B or C or syphilis, pregnancy and BMI <17kg/m2
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in number of ulcerative lesion;Safety and tolerance of SVF injection;Effect on hand disability and mobility (Quality of life)
- Secondary Outcome Measures
Name Time Method Time taken for total healing of cardinal digital ulcer lesion;The reduction in size of cardinal digital ulcer lesion;Newly developed ulcerative lesion after SVF injection