Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major
impact on hand function and quality of life. Digital injection of autologous cultured
adipose-derived stromal constitutes a promising approach to treat scleroderma-induced
refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2
study is to compare efficacy and safety of digital injection of autologous cultured
adipose-derived stromal cell versus placebo for healing refractory active ischemic digital
ulcers in patients with systemic sclerosis.