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Hello,

Dr. Decherchi's study on acute lesions of the spinal cord will be published shortly.  This publication, which is necessary for a clinical trial application, is being evaluated by a reading committee.  If everything goes well, the results of Dr. Decherchi's study on chronic lesions will be published next spring.

As you know, we are in touch with different research teams in France and abroad, as well as with Clinical Investigation Centers (CICs) in France.

Several opportunities are available to the Association, with various funding needs, depending on our choices and the countries with which we are in contact.

In France:

1.       Scientific collaborations:

-          We met with Garches' CIC team in June 2011.  They do not want to rely on Dr. Woerly's work and have asked for additional data on the animal model before considering the clinical stage on humans.   They are now waiting for Dr. Decherchi's scientific publications.

-          Poitiers health-centered Biopole has made a firmer commitment to the Neurogel project by providing a team which will assess the possibilities of conducting a clinical trial for a maximum period of three months.  They are already preparing part of the administrative documents required for a clinical trial.  We are expecting a firm response in the course of February.

-          The company  "Accelence", 1st public/private clinical research Site Management Organization in Europe (http://www.accelence.fr/services/soutien-aux-projets-innovants), contacted and asked me to submit our project to Bordeaux's TIC (Technical Investigation Center) with whom they work.  Accelence would like this TIC to initiate the clinical trial. They have already met with their research team and explained our project which is now being evaluated.

2.       Financial collaborations :

-          We are in touch with the Hopale Foundation (http://www.hopale.com/) which could help us fund a clinical trial.  They also work and are involved with medical teams in China.  Their proposal involves helping us conduct the surgeries in China.  We will be meeting with them in the course of December 2011 to assess this proposal and its feasibility.

-          We are also in touch with several Swiss investors who have funded innovative research projects on biomaterials.   They are interested in the Neurogel project.  We are to meet with them in the course of December 2011.

These contacts are positive, because without the support of the CICs, we would have to hire a specialized company to lead and fund the clinical trial.

Abroad:

We are still in touch with Pr. Eva Sykova.  She is completing her own clinical trial and seems to be more and more bent on using her gel in the clinical trial.  Consequently, we have offered to compare her results with Dr. Decherchi's.  We are not opposed to partnering and supporting her financially, should she obtain better results.  Otherwise, we are still considering conducting a clinical trial in the Czech Republic, which would of course include members of the Association.  We are waiting for her clinical trial's budget evaluation.

We are also in touch with the Tunisian Spinal Cord Research group and in particular with Pr. Mrabeth.  We have asked him to submit an estimate for a clinical trial in Tunisia.  The advantage is that the cost would be lower than in Europe, while clinical legislation would be similar.

Finally, we are in touch with Stempeutics in India (http://www.stempeutics.com/).  Their project is interesting and thorough.  It combines Neurogel with amniotic stem cells.  Pr. Gorio would be involved in the phases of the study spread over three years, and estimated at 400,000 euros.

As you see, our project is ongoing and will be completed.  Some of you may think it is taking an awful long time. I agree!  Considering that we are alone, and that few of our members are actively involved in the project, we are not doing too bad!  We cannot count on the help of our elected officials or even on the help of deputy secretaries in charge of disability,  handicap being considered as negligible in France.  None of our letters have been answered, and I have given up trying to contact these people. 

Thankfully, we have different options to approach potential partners and convince them to choose and fund our project.

As far as the CICs and TIC are concerned, there is no issue.  Should either Garches, Poitiers or Bordeaux be game, we will work with them without hesitation. 

Regarding foreign countries, we already know what the Indian financial needs are; we are now waiting for Prs. Eva Sykova's and Mrabeth's estimates.

As you have already surmised, if we rely on an institutional promoter to conduct the clinical trial in France, we won't need to provide funding; if, on the other hand, we decide to get involved overseas, we will have to provide funding.

However, since nothing prevents us from conducting clinical trials in different locations, in France and abroad, we are encouraged to seek funding for  the project.

Bye for now!

Jean-Luc Gay