Essai clinique paraplégie tétraplégie

Essai clinique | Paraplégie et Tétraplégie

Actors of the clinical trial

Project's holder

Neurogel En Marche chaired by Pierre Rondio (and his scientific council)

Project partner (university of milan, italy)

Pr Alfredo Gorio, Scientific Head of the Italian National Program on Spinal Cord Injury

Project partner

Kunming International Spinal Cord Injury Treatment Center

CHIEF NEUROSURGERY

Pr Lieu Yansheng

FUNCTIONAL REHABILITATION PROJECT PARTNER

Kunming International Spinal Cord Injury Treatment Center (Pr Zhu Hui)

Patients

6 French : Virginie, Eric, Zafer, Michael, Stéphane et Aline

In March 2019, twelve chronic spinal cord injuries participated in a clinical study in China

En mars 2019, douze blessés médullaires chroniques (neuf paraplégiques et trois tétraplégiques) ont participé à une étude clinique au Centre International de traitement des lésions de la moelle épinière à Kunming en Chine. Six patients français et six patients chinois ont bénéficié d’une thérapie pour traiter les lésions de la moelle épinière  avec une matrice de croissance cellulaire autologue issue du tissu adipeux appelée « actived fat » et une médication associée avec de l’érythropoïétine, plus communément connue sous l’abréviation EPO.

Les opérations ont été réalisées au Kunming International Spinal Cord Injury Treatment Center par l’équipe du Neurochirurgien le docteur Liu Yansheng qui a une expertise de plus de vingt ans dans la chirurgie des lésions de la moelle épinière et qui a déposé plusieurs brevets pour la mise au point d’instruments de chirurgie spécifiques pour l’approche des lésions de la moelle épinière. 

All patients had complete ASIA-A paralysis

All patients had a ASIA-A score with a complete motor and sensitive paralysis with lesions sometimes over 6 cm.

The age range of patients is between 20 and 55 years old with lesions dating from one to twenty-three years , including three patients with lesions over 10 years . This clinical study was fully funded by the association Neurogel en Marche in accordance with current regulations.
Patients have followed by intensive rehabilitation of 14 months .

A team that has already performed more than 5,000 operations on chronic and acute injuries

Doctor Lui Yansheng's team regularly applies the protocol established by the late Doctor Antonio REIS for the implantation of activated fat. She has already performed more than 5,000 operations on chronic and acute injuries spinal cord with different therapeutic pathways. Surgery is crucial to free the spinal cord from fibrosis, cysts, adhesions in order to allow it to find its position original and get a normal circulation of cerebrospinal fluid .

Physiotherapy is essential, it must last twelve months minimum

The hospital has an intensive functional rehabilitation center led by the doctor Hui Zhui .

Physiotherapy is essential and must last at least 12 months.
Treatment without significant functional rehabilitation would not allow nerve fibers to form synapses and axons to grow back.
You must stimulate the sub-lesion pathway and the growth cones by the physiotherapy.

Kunming Functional Rehabilitation Center focuses on walking and active exercises with little technical assistance .
Mobilization, standing and weight training exercises are part of rehabilitation, but walking remains the central theme .
The goal is to put the individual on their legs with all their weight so that the sensory feedback is closest to reality .

Doctor Hui Zhu's team has a physiotherapy protocol which adapts to the case of each patient and according to its evolution.
Physiotherapy is 36 hours per week including 5 hours of acupuncture with low frequency electrostimulation .
Patient assessment is done according to a program developed by Dr. Hui Zhu: the Kunming scale .

Le protocole de "graisse activée" en bref

Autologous activated fat gel (from patient)

Has not undergone any genetic or enzymatic modification, acts as a growth medium

High immunosuppressive and anti-inflammatory factors

Presence of certain key factors for the regeneration of the nervous system, associated with EPO

Not very fragile, easy to handle during surgery
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The patient's fat is taken by liposuction , she is sterile processed with a fully patented process. The fat is subjected to a set of mechanical and orbital forces during a specific time and frequencies, which will separate water, blood and oil from adipose tissue. This fat thus activated gives the stem cells qu 'it contains extremely high levels of immunosuppressive factors , anti-inflammatory as well as factors keys for the regeneration of the central nervous system , this without using any chemical or genetic method .

The activated fat stem cells will differentiate and survive for a very long time in the heart of the wounded tissue . In combination with EPO, neural stem cells from the spinal cord migrate to activated fat. They will be able to organize a new neural structure and initiate regrowth of nerve fibers .

 

contact@neurogelenmarche.org