Spanish Institution AEMPS approves the clinical test for a new technique to treat multiple sclerosis

The human testing for the antigen therapy with dendritic cells has been aproved and will be led by Hospital Clinic de Barcelona

Spanish Institution AEMPS approves the clinical test for a new technique to treat multiple sclerosis

Multiple sclerosis
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Multiple sclerosis affects 50.00 patients in Spain alone, and 2.5 million around the world. The are no therapies that can currently fight this disease effectively, and the available ones today have many side effects and are only effective at the first stages, but not at the advanced stage of the disease

The Spanish Agency of Medicines and Sanitary Goods (AEMPS) has approved human testing for the antigen therapy with dendritic cells, a test which will be led by the Hospital Clinic de Barcelona and supported by the GAEM Foundation (Support Group for Multiple Sclerosis Patients), as well as the La Caixa philanthropic foundation. This research stands as a great step forward for the scientific community and for all sclerosis patients, and it is a pioneer technique to provide the utmost efficiency while minimizing side effects. 

Improvements of the antigen-specific therapy with dendritic cells 

This research starts as an agreement between the GAEM Foundation and the researchers at the IDIBAPS branch at the Clinic Hospital of Barcelona, a team led by Dr. Pablo Villoslada and Dr. Daniel Benitez. The technology behind it has been developed by the research team at the Digestive Unit at the same hospital, led by Dr. Julià Panés, who carried out a clinical test with dendritic cells on patients with Crohn´s Disease back in 2011, obtaining impressive results. This same protocol and general procedure was approved to treat multiple sclerosis and neuromyelitis optica (NMO), since both pathologies as well as Crohn´s disease are autoimmune. The main difference between them is that, in the case of Crohn´s disease, the target cell is unknown, whereas the target cell is easier to locate in MS and NMO because tolerance is more focused.

The antigen-specific therapy with dendritic cells is a great progress in the research around EM and NMO, and its final goal is to tune the patient´s defenses in a specific and selective manner, to fight the swelling caused by both pathologies but without altering the functions of all other defensive systems. This treatments works by isolating and maturing a type of white blood cells, known as dendritic cells, making them fight against portions of proteins from myelin and against astrocytes, elements that make the immune system react in a pathologic way. The maturation of these cells intends to suppress the swelling reaction, instead of promoting it. This shift in response would only happen against the target cells that bind to the brain´s proteins. This way, only the swelling against cerebral proteins would be suppressed, without affecting other responses from the immune system that are necessary to fight off common infections or cancer. The patient´s own cells and cerebral proteins would be used for each individual therapy, enabling a more personalized and efficient treatment with no side effects. In addition, the expected characteristics for this treatment are based on animal testing that has already shown success in the treatment of both MS and NMO.

12 patients with either multiple sclerosis or neuromyelitis optica will take part in the test, and some of the criteria for the selection of volunteers are the following: ages between 18 and 65, with over a year suffering the disease, and with a 3.0-8.5 handicap degree according to toe EDSS measuring chart. In addition, some of the criteria for exclusion are the use of corticoid treatment, a surge suffered in the previous month, the presence of a grave systemic disease, a clinical history of cancer, a fertile age in women, or if they are pregnant or lactating.

The expected results of this test are the provision of an excellent degree of safety during the treatment, (an absence of moderate or grave side effects) and to assess the efficiency of the treatment according to the immune system´s response to the cerebral proteins. With this procedure, it would be possible to identify the most adequate doses and the best therapeutic regime to carry out a clinical test on phases 2 and 3 of the disease over the next years, which should prove the effectiveness of the treatment and earn its approval for clinical uses. 

Application of the therapy in other pathologies

The clinical test will begin on the last weeks of July, with the aforementioned 12 patients, to prove the efficiency and safety of this therapy, and researchers hope to conclude their research by the end of 2015. Should all expectations be met, new tests will be carried out at a European level, with the objective of having this therapy ready for use with patients of MS and NMO by 2018. The development of this research is not only a step forward for these pathologies, but is also an opportunity to obtain significant results in humans so that the same procedure can be applied in other autoimmune diseases such as autoimmune encephalitis, rheumatoid arthritis  or psoriasis.