Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial
The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.
• Established diagnosis of SSc according to the 2013 ACR/EULAR criteria
• At least one active digital ulcer (painful area, \>2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins
‣ 'Refractory to prostacyclins' is defined as
⁃ Worsening of ulcer(s) within 1 month after prostacyclins iv
⁃ No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged by the referring physician
⁃ Recurrence of exactly the same ulcer(s) (same location) within 3 months after prostacyclins iv
• Written informed consent