A randomised placebo-controlled double-blind trial to assess the safety of intramuscular administration of allogeneic mesenchymal stromal cells for digital ulcers in systemic sclerosis: The MANUS Trial protocol
BMJ Open Aug 26, 2018
van Rhijn-Brouwer FCC, et al. - The MANUS (Mesenchymal stromal cells for Angiogenesis and Neovascularization in digital Ulcers of Systemic Sclerosis) Trial intended to assess the safety and potential efficacy of mesenchymal stromal cells (MSCs) for digital ulcers (DUs) of systemic sclerosis (SSc). If the results confirm safety, feasibility and potential efficacy, a large multicentre randomised controlled trial with longer follow-up will be initiated focusing on efficacy. The findings might provide a basis for studies in other groups of patients with vascular and/or autoimmune diseases.
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