Allogeneic cell therapy has again shown an effect in type 1 diabetes

“Our vision is to improve treatment options for thousands, maybe millions of patients and reducing healthcare costs with the aid of stem cell therapy.” Mathias Svahn, CEO of Cellaviva and NextCell Pharma.

Type 1 diabetes is an autoimmune disease that affects the body’s ability to produce insulin, a hormone required to stabilize blood sugar levels. There are currently about 20-40 million people with autoimmune type 1 diabetes. An estimated 130,000 children and as many adults are diagnosed each year. Current standard treatments aim to treat symptoms, usually by regulating blood sugar levels without affecting the body’s own ability to produce insulin.

The clinical diabetes study ProTrans ™, unlike previous treatments, has shown a significant effect in preserving the patient’s own insulin production. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo.

“Exciting results. 2 of 9 patients treated with ProTrans had increased insulin production after 1 year and in total 4 of 10 had a decrease of 5 % or less, as compared to 0 of 5 patients receiving placebo”, says Mathias Svahn, CEO of Cellaviva NextCell Pharma, AB.

Cellaviva’s study

Treatment was double blinded, ensuring that neither patients nor their physicians knew whether they had received active treatment or placebo during the 12-month follow-up. After all data had been compiled and monitored by Karolinska Trial Alliance, the code was broken, and the results reviewed by Medical Statistics Unit, Karolinska Institutet.

“Allogeneic cell therapy has again shown an effect in type 1 diabetes. This time in a randomized controlled trial”, says the principal investigator Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital.

ProTrans

Our product portfolio is based on mesenchymal stem cells from Wharton’s Jelly (WJMSCs), i.e. the gel found around the blood vessels in the umbilical cord tissue. Mesenchymal stem cells possess immune modulating capabilities, applicable in a multitude of areas with unmet medical needs, such as autoimmune conditions as well as transplant rejection.

“Umbilical cord tissue is one of the most concentrated sources of mesenchymal stem cells. It contains young, fast-growing and viable cells that can be grown in the laboratory in large volumes. Immunologically, the baby and mother are different individuals and the cells of the umbilical cord tissue therefore express signal molecules so that the mother’s immune system does not repel the fetus – a natural function we use to increase a patient’s tolerance for their own insulin-producing cells, which are under autoimmune attack in type 1 diabetes” says the CEO in an interview in BioStock

The clinical trials are carried out in collaboration with Karolinska University Hospital and Uppsala University and the expectation is that ProTrans will be given to patients directly after diagnosis. ProTrans is given in an attempt to protect the insulin producing cells by modulating the immune system. The effect might be transient, resulting in a longer honeymoon phase or reduced need of insulin, but the goal is to reprogram the immune system to accept the body’s own insulin producing cells. ProTrans reduces the immune systems attack, and thus the insulin production is preserved. By restoring the patient’s innate insulin ability, the need for insulin treatment is reduced.