None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : open label, single arm, one study site with 6-months follow-up
Autologous SVF was obtained from lipoaspirates, using an automated processing system
and on the same day
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in number of ulcerative lesion;Safety and tolerance of SVF injection;Effect on hand disability and mobility (Quality of life) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactSuk-Ho Moon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed