A new clinical trial will assess a new stem cell treatment for diabetes-related kidney disease. The Novel Stromal Cell Therapy for Diabetic Kidney Disease project, NEPHSTROM, will determine if this treatment is safe and consider if it can become a viable therapy for treating this serious disease that threatens millions of people over the next two decades. NEPHSTROM is a collaborative project involving 11 partners, and will be largely funded by the European Union.
What is Diabetic Kidney Disease?
Diabetic kidney disease (DKD) is one of the major causes of renal failure, causing an estimated 125,000 deaths across Europe every year. DKD is caused by the gradual destruction of kidney tissue, a process marked by an immune response and inflammation, which increases blood flow and causes swelling. This, in turn, causes fibrosis and a subsequent loss of renal function due to scar tissue formation. The disease is common among people with Type II Diabetes and could affect 200 million people by 2040.
When kidneys are damaged by the disease, the only available treatments are drugs, dialysis, and a kidney transplant, which are expensive and carry significant risks. NEPHSTROM will assess the use of stem cells known as ‘mesenchymal stromal cells’ (MSC), which are able to regulate immune responses. MSCs may slow or stop diabetic kidney disease before it becomes a serious issue, by reducing hypertension, inflammation, and the resulting fibrosis.
This Phase 1b/2a NEPHSTROM trial will assess 48 adult subjects with progressive DKD, to ensure that the treatment is safe and assess if it is effective. The trial will take place in Ireland, Italy, and the UK, using stromal cells purified from healthy bone marrow drawn from donors.
The stromal cell therapy will use Orbesen’s Cyndacel-M injected into a subject’s bloodstream. The study will also look at ways of improving extraction of the stem cells and reducing costs by scaling up production and promoting consistency through shared production techniques. Results will be gained with the use of indirect measurements of kidney functionality via blood and urine samples to assess if the progress of the disease has been curtailed.
With a finish date of 2020 for the entire project, this is an important initiative that could improve therapeutic outcomes for millions.