Our initial project was based on the idea that an old spinal cord injury could only be treated with a growth matrix to enable neuronal regrowth.
The association therefore supported the concept of a synthetic 3D growth matrix called Neurogel™. This biomaterial was developed by Dr. Stéphane Woerly, a French researcher based in Canada.
The need for a cellular growth matrix is now widely acknowledged in spinal cord injury research.
2003: Attempt at a First Clinical Trial
After the aborted project of a clinical trial in Mexico at the end of 2002, the association Neurogel en Marche tried to conduct a clinical trial in France in 2003 at the Pré Clinic in Le Mans, which agreed to provide its technical facilities free of charge for surgery on 3 or 4 patients.
The association then asked the Ministry of Health to exceptionally authorize a Temporary Use Authorization (ATU) for Neurogel™ for these patients. At the time, we had a few perishable batches of Neurogel™ that had been prepared and tested in Canada. Despite support from 150 members of parliament, the APF (French Association of the Paralyzed), the ALARME association (Free Association for Spinal Cord Research), a demonstration in front of the Ministry of Health under the cameras of France 3…
The Ministry of Health refused to grant an ATU for this trial, wiping out two years of work and investment.
Awakening
This refusal plunged members of the association into deep disarray. Neurogel en Marche realized at that moment the regulatory and financial requirements for conducting a clinical trial, and became aware of its shortcomings:
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It did not know clinical regulations well
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It had little knowledge of chronic spinal cord injuries and the world of disability
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It was poorly structured in its organization, communication, and resources
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It communicated with no researchers and focused mainly on supporting Neurogel™ developed by Dr. Woerly
It also noted that a preclinical study using Neurogel™ in an old spinal cord lesion in rats produced weak results.
The association realized that it lacked sufficient scientific knowledge and began approaching other researchers. It understood that Neurogel™ alone would not be enough to obtain tangible results. This new reality was difficult to accept. The association had to understand the key conditions needed for optimal regeneration with Neurogel™.
The association had to take control of research and all preclinical projects.
This new reality created tensions within the association, especially with its main researcher, leading to legal disputes and internal conflicts that wasted two years.
Ultimately, the association survived and recovered the Neurogel™ patent but found itself alone to carry out a new project.
Rebirth
The association had no choice but to do foundational work and restructure:
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Creation of a scientific advisory board after contacting and analyzing the work of dozens of researchers worldwide
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Creation of an optimized website
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Learning clinical regulations, preclinical and clinical costs, dossier writing
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Fundraising
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Communication with the press and disability-related institutions
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Launching preclinical and fundamental research studies (University of Marseille, University of Milan, University College London, Stempeutics Bangalore in India)
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Hiring a certified accountant
In 2009, the association brought together in Prague the key players in basic research, applied research, and clinical practice.
The foundations of our clinical project were finally established.
2010: The Number 3
Starting in 2010, the association entrusted all preclinical work to Professor Alfredo Gorio’s team at the University of Milan.
The association had already supported various publications and learned that regenerating neurons in the central nervous system produce erythropoietin (commonly known as EPO) and have EPO receptors.
This is a key factor in regeneration and guided all of the association’s research.
From experience, the association then understood that three major medical conditions were required to carry out a clinical trial:
1. CURATIVE SURGERY
Neurosurgeon Antonio Reis, a member of our scientific board, showed that removing the spinal cord lesion scar and replacing it with a cellular growth matrix is not enough for regeneration.
The entire lesion site and environment must be restored: removing all arachnoid cysts, fibrosis, and adhesions—sometimes several centimeters from the lesion—until the spinal cord is fully freed and cerebrospinal fluid circulation returns to normal.
2. A SPECIFIC CELL-GROWTH MATRIX AND EPO
To achieve neural regrowth, a three-dimensional, biocompatible cellular matrix is necessary, containing specific stem cells that express key neurogenesis factors, immunosuppressive and anti-inflammatory factors, and supplemented with EPO to stimulate regrowth.
3. INTENSIVE PHYSIOTHERAPY
This last point was seriously considered by Neurogel en Marche starting in 2009.
Numerous new studies showed that intensive stimulation of the sub-lesional pathway was essential to promote axonal regrowth, with maximal weight-bearing.
For two years, the association spent several months in various specialized private centers in Europe:
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Giusti Center in Florence, Italy
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Dikul Center in Wroclaw, Poland
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Akson Center in Wroclaw, Poland
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Theramax in Alte, Portugal
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Step by Step Foundation in Barcelona, Spain
In the end, the association chose the Step by Step Foundation and forged close ties with it as part of a clinical project.
We then planned to conduct the surgery in Portugal with Dr. Reis.
Neurogel en Marche was received at the Élysée Palace in 2010 to obtain funding for this purpose.
It is now recognized as a public-interest association, and the French National Agency for the Safety of Medicines acknowledged the quality of the overall project developed by Neurogel en Marche.
2014: A New Matrix — Activated Fat
After identifying the key factors necessary for regeneration, Professor Alfredo Gorio’s team at the University of Milan developed in 2014 a new matrix derived from adipose tissue: activated fat, which contains stem cells expressing EPO and all key neurogenesis factors.
The team sought to produce a machine capable of generating activated fat under specific sterile conditions. It also developed and envisioned other treatments with activated fat, particularly for dermal damage (pressure sores, burns, scleroderma, etc.).
Funding was slow to come, so we began seeking external collaborations to finance a clinical project for dermal applications. Contacts were made with laboratories and medical device manufacturers, but industrial and pharmaceutical investors remained unreceptive and preferred to wait.
In 2015, Dr. Antonio Reis wrote the surgical protocol for a clinical trial planned in Lisbon, Portugal. We hoped to conduct the clinical trial in 2016.
2016: From Darkness to Light
The year 2016 proved catastrophic and devastating for Neurogel en Marche.
We lost our neurosurgeon, Dr. Antonio Reis, which collapsed our entire clinical project. Professor Alfredo Gorio, suffering from hip problems and needing surgery, was devastated, seeing no possible future. A long collaboration suddenly ended.
We also lost our dear Stéphanie Mauberret, our secretary, who suffered terribly from cancer.
Our president, Jean-Luc Gay, Stéphanie’s partner, had already stepped down more than a year earlier after having done so much for the association — thank you, Jean-Luc.
At this point, most long-time members of the association had lost hope.
In recent years, Neurogel en Marche had been criticized for raising hopes that never materialized. It failed to unite people with paralysis. The idea of dissolving the association was seriously considered.
Yet dissolving the association would mean that all the work of Stéphanie and all those who had passed away since 2002, giving so much of themselves, would have been in vain.
Thinking of those we honor here:
Jacqueline Olanié
Francis Vincent
Anne-Marie Briotet
Stéphanie Mauberret
Murielle Veron
Antonio Reis
Our late webmaster Frédéric Jouan, who passed away in April 2020 shortly after the start of our clinical trial.
We had to continue and honor their memory. The association then searched worldwide for a team capable of implementing our protocol.
And suddenly, at the end of 2018, after a few exchanges with the International Spinal Cord Injury Center at Tongren Hospital in Kunming, a videoconference meeting, and a meeting in Barcelona, light emerged from the city of eternal spring — we finally rose from the darkness.
​2019: First Clinical Trial in Humans
In 2019, we succeeded in achieving our aspirations.
Six French patients and six Chinese patients received therapy to treat spinal cord injuries using an autologous cell-growth matrix derived from adipose tissue called activated fat, together with associated medication including erythropoietin (EPO).
You can find information related to this clinical trial by clicking here.