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 technological cluster mainly concerns two application areas:
Dermal conditions
● Scleroderma
● Burns
● Pressure sores
● Cosmetic surgery
Central nervous system conditions
● Chronic or acute spinal cord injury
● Myelitis
● Parkinson’s disease
● Amyotrophic lateral sclerosis
● Duchenne muscular dystrophy
● CNS tumors
Prospects for Preclinical Studies:
Parkinson’s Disease in a Mouse Model (University of Milan)
This project was initiated by Dr. Stéphana Carelli and the association Neurogel en Marche. A first (unpublished) study had already shown the effectiveness of stem cells derived from activated fat for Parkinson’s disease in mice. Dr. Stéphana Carelli developed, after nine years of research, a new cellular growth “niche” that uses no biological component or active agent for cell expansion, preventing any tumor growth phenomenon. A major publication co-financed by Neurogel en Marche on this new cell culture method now allows us to consider a new study, as well as studies on ALS or muscular dystrophy. This Parkinson’s disease mouse study, involving injection of cells into the striatum, has been estimated at €27,212.
Duchenne Muscular Dystrophy in Dogs (AFM – Téléthon)
This project was initiated in collaboration with Dr. Stéphana Carelli. We must present to pharmacist and scientist Serge Braun, scientific director of the French Muscular Dystrophy Association (AFM) – Téléthon, a project combining stem cells derived from activated fat and erythropoietin in a canine model. We have just summarized the objective and protocol for this work and will submit a dossier. If accepted in this call for projects, funding will come from the AFM–Téléthon association.
Amyotrophic Lateral Sclerosis in a Mouse Model (ARSLA Association)
We will submit a dossier for 2021, again combining stem cells derived from activated fat and erythropoietin in a mouse model. If accepted in this call for projects, funding will come from the ARSLA association.