Posted by fredjouanon 2012/5/18 18:03:17 (0 reads)
From the President’s desk – May 2012
Posted by Fred Jouan on 05/17/2012
Hello,
Dr. Decherchi has presented his publication to the editors of several scientific journals specialized in biomaterials. So far, this publication has not sparked any interest on the grounds that it is not innovating enough, or somewhat “déjà vu.” This is very frustrating given the current state of spinal cord research in France! However, there are a lot of other journals to be contacted yet, and Dr. Decherchi’s remains confident he will be successful. What’s more, he is pressing on, and is starting work on statistics, hystiology…and chronic lesions.
All this is taking time of course, but as you can surmise, neither the CIC, in Garches, nor the CIT, in Bordeaux will take on a clinical investigation and its cost without this official publication. Without it, we cannot proceed in France.
This said, the Association can also choose a more rapid path by accepting proposals from overseas. The most promising ones are in India and more recently China – the latter, a very serious medical center, well-known by Dr. Decherchi, would not be very expensive for us. We have just started our discussions but need to further explore our options.
This discussion on the possibilities of a clinical trial overseas will be at the heart of our next general assembly which I would like to set up in June or July. We will also be discussing the running of our association. Today, we can count the number of people involved in the AC on the fingers of the hand – many left for personal reasons – family or health issues. This situation cannot go on.
Let me also avail myself of the opportunity to remind those who wish to renew their membership that they do not have to wait for the reminder that will be sent out along with an invitation to the general assembly.
Finally, I am proud to inform you that Jo Kals, a 50 year old paraplegic who walked across France, talked about the Association during Paul AMAR’s radio show “Revu et corrige” on France 5, May 05. His next challenge: the Eiffel Tower!
Posted by stephaneon 2011/1/11 16:20:00 (615 reads)
The purpose of this space is to provide a list of frequently asked questions regarding the Association or its project. Feel free to post your comments or questions here.
Posted by fredjouanon 2011/12/8 11:55:49 (78 reads)
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.
