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DIABETIC KIDNEY DISEASE

Diabetic kidney disease is responsible for the deaths of approximately 126,000 Europeans every year. It is the leading cause of kidney failure, and may contribute to hypertension and cardiovascular disease. There are currently no treatments to reverse the effects of DKD.

STEM CELL THERAPY

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.

CLINICAL EVIDENCE

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.

ENABLING THE FUTURE

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.