NCT02975960

ADMSCs for the Treatment of Systemic Sclerosis

Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	injection 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.

Timeline

• Start date: 2016-10-25
• Primary completion: 2017-10-30
• Completion: 2018-01-20
• First posted: 2016-11-29
• Last updated: 2018-01-25

Locations

1 site across 1 country: South Korea