NEPHSTROM will deliver and validate a transformative mesenchymal stem cell (MSC) treatment, Orbcel-M. MSCs have already demonstrated the potential to target the five major aspects of DKD – hypertension, inflammation, fibrosis, oxidative stress, and proteinuria – with a single treatment. NEPHSTROM will trial Orbcel-M in treating all of these simultaneously.
NEPHSTROM will carry out a first in man Phase 1b/2a clinical trial of a novel stromal cell therapy. This trial will evaluate the clinical safety and efficacy of systemic administration of allogeneic mesenchymal stromal cells (MSC), as a therapy for patients with progressive diabetic kidney disease.
NEPHSTROM will develop and validate a new combined manufacturing platform that improves the consistency and reduces the cost of the MSC therapeutic, making it a viable option for routine clinical use. This will involve the development of the first “closed-automated” GMP method of MSC isolation and expansion, and the creation of a network of four European cell production centres. This technology will enable the upscaling of consistent, regulatory-friendly MSC production.