Madrid, May 16 (press release)
Treatment with cannabidiol along with hypothermia can reduce brain damage between 80% and 100% in infants with severe asphyxia, according to tests conducted in pigs, mice and rats by researchers from the Institute of Neuroscience. A health study of the San Carlos Clinical Hospital of Madrid, led by the head of the Neonatology Department of the Hospital Center, José Antonio Martínez Orgado.
This is the first time that the results have been published on cannabidiol for the treatment of neonatal and hypoxic ischemic damage in both severe and moderate cases. Data from all preclinical trials performed so far have been published in journals such as Children's Research and Limits in Neuroscience. Or 'neuropharmacology'.
Every year around the world, most of them die in Third World countries, one million newborns suffer from acquired brain damage and two million suffer from severe life disorders. In addition, it is estimated that at any moment in the world, four children suffer from brain damage, two and three minors each week in Spain.
Despite advances in infant care, there is currently only treatment with therapeutic hypothermia, which reduces the risk of death or severe disability, but only a very small group of children. Specifically, of two or three infants with severe asphyxia per 1,000, 50% of candidates for hypothermia, and those only 54% receive benefits. Also, it can have important side effects that can sometimes cause death.
For this reason, researchers at San Carlos Clinical Hospital in Madrid have analyzed, in animal studies, the potential that cannabidiol can be in these infants, since it is cannabinoids without psychotomoletic effects, whose potential is based on this is one of the most powerful anti-inflammatory antioxidants existing, At the same time the three main causes cause brain damage: inflammation, oxidative stress and excitotoxicity. It is also a "strong" anticonvulsant and anxiety, which offers additional benefits for treating newly born patients.
Indeed, preclinical trials have shown that cannabidiol itself significantly reduces brain damage due to asphyxia in infants in moderate to severe condition. Specifically, researchers have shown that parenteral administration of cannabidiol in cases of neonatal brain injury in moderate mild hypoxic source reduces injury by 50 percent according to histological and magnetic resonance testing, and up to 100 percent functional disability, as observed in functional or neurological examination tests.
Also, scientists have found that this benefit is maintained in the long term, even if the treatment begins at 18 or 24 hours after the onset of damage, thus expanding the therapeutic window regarding hypothermia, which should be given the first six hours. "We also found that cannabidol has no side effects," Dr. Martinez Orddo said. "The treatment has therefore shown to be effective even when administered alone, in mild cases, and when hypothermia is done in severe cases.
These results led the European Medicines Agency (EMA) to approve the first clinical trials in Europe, to be coordinated in Spain by the clinical hospital, to test this in infants with asphyxia during childbirth and that they should receive hypothermia. The study will begin at the end of the summer and the first results are expected to be published within a year and a half.
In this work, 30 to 40 newborns will participate, which will be provided blindly to researchers, cannabidiol or placebo. "What we want to prove is safety and efficacy," said Dr. Martinez Orgado, after reporting that the study would be coordinated at a general level in a UK hospital, since the funding of pre-clinical work was paid by the British laboratory GW farmaceuticals.
"Prevent more scars and suffering for the future"
The good preclinical outcomes, and those that could leave the clinical trial, were welcomed with the hope and enthusiasm of patients and family members who were injured by brain damage, and were also transferred by the association's president with spasticity, Claudia Tekelen; Paralympic European champion, Lorenzo Alvalado; President of the Don Palacio Fund, Paloma Pastor; President of the Grosso Garcia Foundation, and Garcia Garcia.
"The simple fact of being able to breathe without pain is luck and such research can allow many children to breathe and prevent many tears and suffering in the future, for which my family and I have gone," said Taklen, a psychologist born in 22 weeks of pregnancy with 900 grams of weight, And his protection was death or remained in the flora and fauna.
In a state of disability is also Albadalejo, who suffered hypoxia during childbirth. "I was born in the 90's and now thanks to research, people who suffer from it can suffer less results," said the disabled athlete, who stressed the need for administrations to increase budget for funding projects. Research
Also, Pastor García said that the project is "great hope" for both patients and mothers who may suffer complications in the future birth. "Why is it so hard to help research? The disability is there and we need help," said the President of the Foundation Ricardo Jeroía.