Multiple sclerosis experimental therapy, stem cell transplantation perfectly managed at S.Pio di S. Giovanni Rotondo in the Clean Rooms designed and realized by Assing S.p.A.
Multiple sclerosis, stem cell transplantation on 3 patients. No side effects. The hospital of San Giovanni Rotondo takes part in the experimentation
Stem cell transplantation on the first three patients with multiple sclerosis. The experimentation coordinated by Angelo Vescovi, scientific director of Revert Onlus and of the Casa Sollievo della Sofferenza Hospital in San Giovanni Rotondo, which conceived and coordinated the study, began positively. Treated patients are well and do not have side effects. The announcement was made in the Vatican, on the occasion of the National Assembly of the Pontifical Academy for Life, by Monsignor Paglia and by Vescovi. The phase I clinical trial on secondary progressive multiple sclerosis is carried out in collaboration with the Terni Stem Cells Foundation, the Santa Marià Hospital of Terni, the Swiss Institute for Regenerative Medicine and the Cantonal Hospital of Lugano.
The transplantation on the first sample of patients occurred with the injection of 5 million stem cells into the cavity of the lateral cerebral ventricle to promote its diffusion in the central nervous system through the cerebrospinal fluid. The treatment, performed by the neurosurgeon Sandro Carletti, head of the Neuroscience Department of the Santa Maria Hospital in Terni, took place without complications and there were no adverse events attributable to the procedure. The last patient was treated last June 13th.
“We are proud of the results achieved in this first part of the experimentation,” says Vescovi. “Patients are under control and are fine: we have not detected any evidence of side effects. The one undertaken is a long and complex path, but the conclusion of the transplantation on the first group of patients is a positive sign that represents a new goal for Italian scientific research towards the treatment of neurodegenerative diseases. Although it is a phase I trial, we have built the experimental design so as to have some chance of being able to detect any therapeutic effects ».
The team of clinicians and researchers is now awaiting authorization to proceed with brain stem cell transplantation in the next few groups of patients enrolled for the Phase 1 clinical trial, which has the exclusive purpose of assessing safety and the tolerability of the therapy. The trial will involve 15 patients, aged between 18 and 60, suffering from progressive secondary multiple sclerosis. The cellular dose, equal to 5 million stem cells in the first group, will be doubled in the second group and progressively increased in the subsequent groups of patients, to allow the evaluation of possible neurological and therapeutic effects. A monitoring period will follow which provides for monthly checks in the first year and half-yearly in the next five years from the intervention.
ONLINE, 27 June 2018