Fetal stem cells against stroke
The inconsistency of the study conducted under the leadership of Professor Keith Muir at the Institute of Neurological Sciences in Glasgow, Scotland, is that genetically modified nerve stem cells of the ReN001 line injected into patients were obtained by specialists of the British company ReNeuron from a stem cell line isolated about 10 years ago from the brain of a 12-week fetus.
After five years of regulatory failures, the study finally began in late 2010. Within its framework, it was planned to administer different doses of ReN001 cells to 12 male patients over the age of 60 with moderate or severe functional neurological disorders after a stroke. To date, only 6 patients who received low doses of cells have been included in the study. The remaining 6 will begin therapy with higher doses (approximately 20 million cells) over the coming months.
The researchers presented the interim results of treatment of 5 out of 6 patients at the X Congress of the International Society for Stem Cell Research (ISSR), held on June 13-16 in Yokohama, Japan. They claim that so far, no undesirable side effects have been reported in patients either from stem cells or from the immune system. Some of them had minor problems in the form of infection of the surface layer of the scalp or small bleeding from the site of cell injection.
Despite the fact that the main purpose of the study is to assess the safety and tolerability of ReN001 cell therapy, patients are also tested for motor and brain functions in order to identify possible improvements in their condition.
One of the tests, conducted using the stroke scale developed by the US National Institutes of Health, evaluates speech, eye motor activity, the ability to move arms and legs, as well as the sensitivity of limbs and face. Higher scores on this scale correspond to more severe disability. According to scientists, before the start of the study, the median of indicators for the first 5 patients corresponded to 8 (in the range from 6 to 10). 3 months after the start of therapy, it decreased to 4 (from 3 to 9). The results of brain scans obtained before and after therapy using magnetic-nuclear tomography also showed changes corresponding to the observed improvements.
According to clinicians, the data obtained to date indicate the safety of the administration of tested doses of cells of the ReN001 line. The preliminary results obtained at the same time, indicating a potential improvement in the functional state of patients, must be confirmed in a properly planned clinical efficacy study (phase II).
The article by George S. Mack ReNeuron and StemCells get green light for neural stem cell trials is published in the journal Nature Biotechnology
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru according to Medical News Today:
Stroke Treatment Using Stem Cells Shows Early Promise In Controversial Trial.
18.06.2012