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New Stem Cell Treatment for Crohn’s Disease
Crohn’s Disease is a Chronic inflammatory disease of the digestive system, it affects up to 1.1 million people in the European Union and has a range of symptoms.
The symptoms include fatigue, weight loss, diarrhoea, abdominal pain and blood in faeces.
Currently, Crohn’s is a lifelong disease with no cure. It also affects people most commonly in early adulthood or late adolescence.
A new development by TiGenix has seen the first stem cell therapy to treat Crohn’s, receive the go-ahead in Europe.
This new stem cell therapy has just been approved by the European Commissions.
Alofisel is a stem cell therapy, which uses adipose-derived, mesenchymal stem cells.
This treatment offers an alternative to people suffering from Crohn’s disease, instead of enduring several surgeries, a patient has the opportunity to try this stem cell therapy.
Alofisel, previously known as Cx601, was developed by a Belgian biotech company called TiGenix which is licensed to the Japanese Takeda. Currently, the marketing authorization comes with a £15m fee for TiGenix, this will then mean the authorisation will transfer to Takeda.
“The process will take a couple of months,” Eduardo Bravo, CEO of TiGenix, said, “Then Takeda will launch Alofisel in EU countries as it negotiates reimbursement.”
These adipose-derived, mesenchymal stem cells have an effect which means the stem cells treatment works by inducing, enhancing, or suppressing an immune response. This was tested in the Phase III of the trial which examined over 200 patients.
The trial considered if the stem cell therapy closed all fistulas, leaving no remaining infection in the patients within the study, visible with an MRI.
“With such strict efficacy criteria, 50% of patients closed all their fistulas with a single dose of Alofisel,” says Eduardo Bravo.
A single dose of Alofisel also showed 42% more efficacy than the treatments Crohn’s patients were receiving – the most common being a combination of Infliximab and immunomodulators.
A Phase III study is still seeking approval in the US and was started last year with results expected to be seen by 2020.
Both stem cell companies are now waiting to receive approval from authorities to begin the takeover process, which is expected to happen within a number of days.
You can find more information on stem cell treatments on our website.
Protect Their Future Health
We believe the best stem cells to use in emerging treatments will be the patient’s own stem cells as this doesn’t require a search for a suitable donor and in turn, eliminates chances of the transplanted cells being rejected.