The Vall d'Hebron Barcelona Hospital Campus, the Virgen del Rocío University Hospital in Seville and the University Hospital Complex in A Coruña are leading the first clinical study in Spain to assess the efficacy of a treatment with mesenchymal stem cells in acute traumatic spinal cord injuries. The study, promoted by Ferrer Advanced Biotherapeutics and the Basque biopharmaceutical company Histocell, has already recruited 5 patients (3 from Vall d'Hebron who also contributed with the first patient to the study), and will be completed in 2020.

The principal investigator is Dr. Miguel ángel González Viejo, head of the Rehabilitation Service and responsible for the Medullary Injury Unit in Vall d'Hebron and investigator of the Vall d'Hebron Research Institute (VHIR).

SPINE (SPinal acute Injury Neurosave Evaluation) is a Phase I-II clinical study (code FAB 117-CT 01), which assesses the feasibility, safety, tolerability and efficacy of the administration of a new drug based on allogeneic adult mesenchymal stem cells of expanded adipose tissue in patients with traumatic acute spinal cord injury (TASCI). These cells have been programmed to resist in the toxic environment that is produced in the bone marrow in TMAHL and reduce inflammation. To this end, 6 patients in phase I and 40 in phase II in three hospitals that lead the project will be selected. "One of the problems to achieve a rapid inclusion of patients are the strict criteria of inclusion and exclusion for the sake of the safety of the participants," says Dr. González Viejo.

The study protocol has been signed and authorized by the Spanish Agency of Medicines and the ethics committees of the different institutions involved.

Functional improvement of the patient

The first phase will assess patients aged 18-65 with traumatic spinal cord injury complete ASIA A, at dorsal neurological levels, from D5 to D10, with motor and sensory complete injury and time between the 72 and 120 hours after the trauma. In the second phase, patients with ASCI ASIA A, with complete and sensory motor injury, and B, with complete motor injury but present sensitivity, with neurological levels between D1 and D12, will be treated. They will be followed for 12 months after the injection of the medication, which will be done in the spinal cord at 6 levels above and below and on both sides of the centre of the injury.

The goal of treatment is to achieve functional improvement of patients at two neurological levels, moving from Asia A to Asia C and from Asia B to Asia D. I.e. regain sensation and mobility in the lower extremities. The first tests in the laboratory have achieved positive results, demonstrating its efficacy in basic research, given that until now the different methods used, essentially drugs that have not achieved the expected results. Dr. Miguel ángel González Viejo, head of the Rehabilitation Service and head of the Vall d'Hebron Medullary Injury Unit, pointed out that "this form of action is new within the therapeutic arsenal that we have at our disposal so far".

In this sense, he stressed that this is a "major study on the evolution of the lesion in the first few hours, when the best results can be achieved, since it sets in motion a model of care that consists of acting early on the inflammatory process, on the so-called secondary lesion that occurs in the hours immediately following the acute spinal cord injury, which allows direct action to be taken on the lesion, at the time of the surgical intervention to stabilise the fracture, decompress the spine and align the spine."

A model of care that can only be carried out in hospitals with the characteristics of those participating in the study, which have spinal cord injury units for acute care and orthopaedic spine surgery and neurosurgery services within a centre with the highest level of care, which must have all the resources, an intensive care unit, specialised nursing staff and a high level of care coordination, including the Medical Emergency Service.

Acute spinal cord injury

The incidence of traumatic spinal cord injury has remained stable in recent years, standing at 4.4 cases per million inhabitants. It is more common in men than in women, with a ratio of 3.6 men for every woman injured.

The causes are various. In adults, the most common is the traffic accident (approximately 40%). The main determining elements are high speed, non-use of safety systems, as the helmet or belt, consumption of alcohol and drugs, and the poor quality of the initial assistance.

The second most common cause is the accidental fall, which represents 35% of the cases, and primarily affects the older population, which, on the other hand, is increasing. In paediatric patients, the most common lesions occur in road traffic accidents, including the road traffic crashes. In fact, it is the leading cause of death in newborns, children and adolescents.

Spinal Cord Injury Unit of Vall d'Hebron

In 2017, the Vall d'Hebron Spinal Cord Injury Unit treated 191 patients from Catalonia and Andorra, 79% of whom were male and 21% female, with an average age of 51 years. Of them, 100 were non-traumatic injuries (resulting from diseases and degenerative processes) and the remainder, 91, lesions of traumatic origin. Before arriving at the unit, 27% of patients had required admission to the ICU of Neurotrauma. Average length of stay in the injured spinal cord unit was 25 days for patients with non-traumatic spinal cord injury and 56 days for those who had suffered traumatic injury.