What is this trial?

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

In March 2019, twelve chronic spinal cord injuries (nine paraplegics and three quadriplegics) participated in a clinical study at the International Treatment Center spinal cord injury in Kunming, China. Six French patients and six Chinese patients received therapy to treat spinal cord injuries with an autologous cell growth matrix from adipose tissue called " fat enabled "and an associated medication with erythropoietin , more commonly known by the abbreviation EPO.

Transactions were performed in Kunming International Spinal Cord Injury Center by the team of Neurosurgeon Doctor Liu Yansheng which has expertise of over twenty years in surgery for spinal cord injuries and who filed several patents for the development of surgical instruments specific for approaching spinal cord injuries.

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. < br> You must stimulate the sub-lesion pathway < span style = "font-size: large;"> and the growth cones by the physiotherapy.

Kunming Functional Rehabilitation Center focuses on walking and < / span> 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 .

The "Activated fat" protocol in brief

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 .