*MS Article-Stem Cells*

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Stem Cell Therapy In Multiple Sclerosis - Now It Is Time To Really Start

Main Category: Multiple Sclerosis News

<http://www.medicalnewstoday.com/sections/multiple_sclerosis/>

Article Date: 24 Nov 2006 - 0:00am (PST)

Clinical research with human stem cells to repair brain damage in MS

patients should be intensified. Although not unanimously, this was the

main conclusion of an international medical scientific conference on MS

and stem cell therapy in Italy today, organised by the independent

European Charcot Foundation.

The promising results of the vast number of experiments in animal

models, may not always be predictive for results in man. Hence, to learn

if stem cell therapy in MS is as effective and safe as suggested, the

focus in R & D must shift from the lab to the clinic.

According to the 300 scientists gathered today, preconditions to this

challenging research are:

-- autologous stem cells should be used (derived from patients' own bone

marrow, skin, blood). Pre-clinical research shows that effectivenes and

safety profile of treatment with autologous bone marrow cells are

relatively positive, virtually no rejection occurs and ethical

considerations are limited;

-- harvesting, culturing, purification and storage of the human stem

cells should be performed in specialised labs under specific

GMP-regulations;

-- procedures of clinical stem cell trials should be standardised and

centrally coordinated, as well as reporting and central database

management of all stem cell transplanted patients;

-- ethical issues should be addressed properly, e.g. how to trade-off

the cost/benefit ratio, when the benefit is yet unclear at the given

scientific status quo and certain risks cannot be ruled out, while the

irreversibly ill patient has no other perspectives anymore.

Some scientists at the conference, pledged for more fundamental research

before stem cell treatment in man should start at all. " It is beyond

doubt that there is lots of research work to be done on the nature of

brain damage and natural repair mechanisms of nerve tissue, on the

interaction between immune system and stem cells and on various other

aspects in this complex neurobiological arena.

However, there is growing, although sometimes inconclusive or casuistic

evidence of clinical relevant brain-repair and protective properties of

transplanted stem cells. Given the urgency of finding a cure for this

widespread, disabling disease, most scientists argued that it is

justifiable to arrange a rapid onset of well managed trials " , concluded

professor O.R. Hommes, chairman of the European Charcot Foundation.

" The proof of concept is available. Now it is time to proceed to the

clinic. Therefore, we presented today a concept of a groundbreaking

phaseI/II clinical trial, to be executed with some 60 severe MS patients

in 5 or 6 centers across Europe. The goal is primarily to evaluate

safety and feasibility of the stem cell treatment, and secondly to

investigate the repair and protective effect in the brain, as can be

monitored with MRI on a cellular level, and in reporting of development

of the functional abilities of the patient - as the ultimate parameter, "

stated Hommes.

The outline of this decisive trial was thoroughly discussed during this

scientific meeting.

European Charcot Foundation

Hoeveveld 18 a

6584 GG Molenhoek (Nijmegen area)

The Netherlands

http://www.charcot-ms.eu