2023
Preclinical Trial on Acute Injury
(acute injury = a few hours after the accident)
Aix-Marseille University
Evaluate the protective and reparative effects of adipose tissue and EPO following an acute spinal cord injury.
Our association funded a preclinical acute-phase trial (within the first hours after the accident) in rats at Aix-Marseille University. Professor Decherchi’s team conducted the study on 120 rats.
The results are therefore very encouraging and will be officially released and communicated once the final closure of the trial is completed.
This project was initiated by Dr. Stéphana Carelli and the association Neurogel en Marche.
The study will be carried out by the team of Professor Patrick Decherchi and Dr. Tanguy Marqueste (a member of our scientific board).
Future outlook: conducting a clinical study in humans
This project could be carried out in France. Such a clinical study in humans requires clinical authorization and the support of a CRO (Clinical Research Organization).
The goal of this research program is to include the therapy, the surgical protocol, informed consent forms, clinical authorizations, patient inclusion criteria, physiotherapy, and follow-up. The average cost of a CRO is €300,000.
A study on 25 patients would provide a solid dataset. Estimating that the surgical costs would fall to the sponsor, we know that this surgery has an average cost of €12,000.
The total cost including hospitalization but excluding rehabilitation could approach €300,000. With a total of €600,000 this study could begin after our results in rats, considering that functional rehabilitation would then be carried out in France or abroad (Centro Giusti Florence, Step by Step Barcelona, etc.), but in the latter case at the patient’s expense.
2023
Preclinical Trial on Chronic Injury
(chronic injury = more than one year after the accident)
Objective: ultimately provide delayed care for spinal cord–injured patients to increase sensory-motor recovery. This involves training neurosurgeons in the surgical technique developed by the Kunming International Center, as well as creating a private center within a foundation to develop intensive rehabilitation.
Aix-Marseille University
Again with Professor Decherchi’s team, a chronic-phase preclinical trial began in 2022.
Future outlook: conducting a clinical study in humans in France
At this stage, it remains a long-term project unless exceptional resources become available. However, this ambitious project is still achievable with the mobilization of people living with paralysis.
Estimating a cost of €4 to €5 million, this would represent 5,000 paralyzed individuals contributing €1,000 each — which is not impossible!
Phase 1 BIS Clinical Trial at the Kunming International Center
(on chronic injury)
Our Long-Term Clinical Prospects
Activated fat and stem cells derived from activated fat open a new era of regenerative medicine based on epigenetics through mechanotransduction, a set of physical forces and constraints modifying the tissue and cellular environment.
The technology hub primarily focuses on two areas of application:
Derma conditions
● Scleroderma
● Burns
● Bedsores
● Cosmetic surgery
Central nervous system conditions
● Chronic or acute spinal cord injury
● Myelitis
● Parkinson's disease
● Amyotrophic lateral sclerosis
● Duchenne muscular dystrophy
● Central nervous system tumors
Perspectives from preclinical studies:
Parkinson's disease in a mouse model (University of Milan)
This project was initiated by Dr. Stéphana Carelli and the Neurogel en Marche association. An initial (unpublished) study had already demonstrated the effectiveness of stem cells derived from activated adipose tissue against Parkinson's disease in mice. After nine years of research, Dr. Stéphana Carelli developed a new cell culture medium that uses no biological components or active agents for cell expansion, thus preventing any tumor growth. A major publication, co-funded by Neurogel en Marche, on this new cell culture method, now makes it possible to consider a new study, as well as studies on ALS or muscular dystrophy. This study on Parkinson's disease in mice, involving the injection of cells into the striatum, was estimated at €27,212.
Duchenne Muscular Dystrophy in dogs (AFM – Telethon)
This project was initiated in collaboration with Dr. Stéphana Carelli. We are to present to pharmacist and researcher Serge Braun, scientific director of the French Muscular Dystrophy Association (AFM) – Téléthon, a project combining stem cells derived from activated adipose tissue and erythropoietin in a canine model. We have just summarized the objective and protocol of this work and will submit an application. If our project is selected as part of this call for projects, it will be funded by the AFM–Téléthon association.
Amyotrophic lateral sclerosis in a murine model (ARSLA Association)
We will submit an application for 2021, again combining stem cells derived from activated adipose tissue and erythropoietin in a mouse model. If our project is selected under this call for proposals, it will be funded by the ARSLA association.