Multiple Sclerosis - Italians Lead Clinical Trial Testing Safety and Effectiveness of Stem Cell Transplantation MS Patients

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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. Promising results are that so far the treatment appears safe, without adverse side effects.

Multiple Sclerosis - Italians Lead Clinical Trial Testing Safety and Effectiveness of Stem Cell Transplantation MS Patients

(ANSA) – 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 Uccelli.

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 minor”. 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.