Venerdì, 18 Gennaio 2019
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MS stem-cell breakthrough led by Italians


Boston, September 9 - Mesenchymal stem cell therapy
to treat multiple sclerosis so far appears safe and without side
effects, according to data released Tuesday and obtained through
clinical trials on patients as part of the international Mesems
project coordinated by University of Genoa neurologist Antonio
The results were announced ahead of the World Congress on
Treatment and Research in Multiple Sclerosis opening in Boston
Wednesday through Saturday.
The Mesems project involves researchers from nine countries
- Italy, Spain, France, Britain, Sweden, Denmark, Switzerland,
Canada and Australia.
It is the first large phase II international multicentre
clinical trial to determine the safety of a consensus treatment
protocol established by the International Mesenchymal Stem Cells
Transplantation Study Group to obtain information on its
effectiveness on multiple sclerosis patients.
So far, 81 patients have been involved in the project - half
of the 160 needed for the whole clinical trial.
About 73 - or 90% of those involved in blind testing - were
given at least one injection with mesenchymal therapy or got a
placebo while 51 - or 63% - were given both injections and 27 -
33% - completed the study.
"The promising result is that so far none of these 27
people have suffered significant adverse events, which means
that, so far, the treatment appears to be safe", said Uccelli.
The neurologist warned that "caution is necessary" and that
the effectiveness of the therapy can only be determined once the
study is completed in 2016.
Uccelli however added that preliminary studies on animals
have persuaded researchers that mesenchymal stem cells "can halt
inflammation on the central nervous system and probably succeed
in protecting nervous tissue, even repairing it where damage is
Out of the 81 patients recruited so far, "28 are Italian
and 10 of them have completed the study", Uccelli said, adding
that all patients over the past year did relatively well except
for one who was treated with placebo.
The neurologist expressed the hope that "data in 2016 will
give final confirmation that the therapy is effective so we can
take the subsequent step with a larger phase III study aimed at
demonstrating the role of stem cells as neurorepairers".
Meanwhile Genoa's bioethics committee has approved a
two-year extension of the project, which will be called Mesems
Plus, "to verify, beyond the year of observation provided for by
Mesems, the long-term safety of treatments in the study and the
potential insurgence of adverse events in all those treated",
said Uccelli.

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