Project for a Second Phase 1 Clinical Trial at the International Spinal Cord Injury Center in Kunming, Yunnan Province (China) for 8 French Patients
What is the cost of such a study?
The cost per patient is between €90,000 and €130,000.
This amount includes surgery, medication, hospitalization, all laboratory and medical fees, examinations, follow-up assessments, one year of physiotherapy, as well as accommodation.
Flight costs, meals, and the fees for a caregiver during the hospitalization period are not included.
The daily cost for a caregiver available 24/7 is €30.
The average cost of a meal is €2.
Assistance from the University of Milan for liposuction, fat activation, transport fees, and contract preparation amounts to €12,000.
For 8 patients, the association therefore needs a total amount between €732,000 and €1 million.
How will volunteer patients be selected?
Patients will be recruited according to the following criteria:
Inclusion criteria
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The patient must have a complete motor and sensory deficit.
ASIA A score = no motor function or sensation in the S4–S5 area. -
Patient age must be between 20 and 45 years.
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No restriction on the age of the injury.
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No restriction regarding the size and/or number of lesions.
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Complete or incomplete paresis.
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Incomplete lesion (the spinal cord must not be fully transected).
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Lesion between C5 and T11.
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Must be a member of the association.
Exclusion criteria
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Patient under 20 years old.
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Diabetes.
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Hepatitis B or C infection.
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Acquired Immunodeficiency Syndrome (AIDS).
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Tendon restrictions and inability to maintain an upright position (with a standing frame).
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Pregnant or breastfeeding woman.
Required examinations
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MRI of the lesion
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MRI of the thigh and calf muscles
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X-ray and/or CT scan of the spine
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Electromyography of muscles and peripheral nerves
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Somesthetic tests (motor and sensory evoked potentials)
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Psychological tests: Rorschach, Rosenzweig, Raven.
Minnesota Multiphasic Personality Inventory -
Urine and blood tests
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Electrocardiogram
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Doppler ultrasound of the legs
Why is the operation not performed in France?
The surgical protocol developed by neurosurgeon Antonio Reis from Lisbon, who was part of our scientific board, consists — even before implanting the matrix called “activated fat” — in restoring the entire site and environment of the lesion: removing all arachnoid cysts, fibrosis, and adhesions, sometimes several centimeters around the injured site, until the spinal cord is fully freed and cerebrospinal fluid circulation returns to normal.
This technique is not used for chronic spinal cord injuries in France.
The clinical trial was supposed to take place in Lisbon, but after Dr. Antonio Reis passed away in 2016, this was no longer possible.
The association then searched worldwide for a team capable of carrying out our protocol.
It turned out that only the International Spinal Cord Injury Center of Tongren Hospital in Kunming had the required expertise.
Are there rehabilitation centers in France equipped to receive patients returning from China?
Some functional rehabilitation centers in France are fairly well equipped, but the human resources are too limited to provide intensive physiotherapy (6 hours per day).
A patient in a French rehabilitation center only receives one to two hours per day at most.
The association Neurogel en marche has a project to create an intensive physiotherapy center in France and to train therapists.
This project will require significant funding; we will soon provide more details about this major initiative.
What rehabilitation program is required after the operation?
It involves intensive physiotherapy, 6 hours per day, adapted individually according to the patient’s progress.
There is:
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a static gait robot
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a spatial gait robot similar to exoskeleton technology, especially at the beginning
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numerous upright-position exercises combined with specific mobilization exercises
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several Motomed devices
All of this is aimed at gait training, initially very assisted, following a progression scale called the Kunming Scale.
Acupuncture is also used, with needles connected to electrical stimulation.
Kunming Scale
When will a new clinical trial take place?
his will depend entirely on our funding, the mobilization of paralyzed individuals, their families and friends, as well as public health conditions.