drugset / Trial / NCT02975960

ADMSCs for the Treatment of Systemic Sclerosis

NCT02975960

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-10-25
Primary completion
2017-10-30
Completion
2018-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy Subcutaneous

Indications