Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Phase 1/2 Recruiting 20 enrolled UMC Utrecht ZonMw: The Netherlands Organisation for Health Research and Development · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2021-10-06
Primary completion: 2026-11-01
Completion: 2026-11-01

Publications

van Rhijn-Brouwer FCC, Gremmels H, Fledderus JO, Schuurman AH, Bonte-Mineur F, Vonk MC, Voskuyl AE, de Vries-Bouwstra JK, Coert JH, Radstake TRDJ, van Laar JM, Verhaar MC; MANUS Study Group. 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. 2018 Aug 20;8(8):e020479. doi: 10.1136/bmjopen-2017-020479.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mesenchymal stem cells	Cell therapy	50 cells	Intramuscular

Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Summary

Timeline

Publications

Drugs

Indications