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Three Spanish public hospitals study the safety and efficacy of the first cell therapy to treat acute traumatic spinal cord injury

Histocell SPINE

Histocell and the pharmaceutical company Ferrer today announced that the first patients have been recruited for a Phase 1/2 clinical trial of FAB117-HC, a new cell therapy medicinal product for the treatment of acute spinal cord injuries of traumatic origin.

It is the first cellular medication designed to treat acute traumatic spinal cord injury, in the first 2-3 days after the accident, that has reached the clinical regulatory phase.

SPINE (Spinal acute Injury Neurosave Evaluation) is a Phase 1/2 clinical trial that evaluates the safety and preliminary efficacy of the drug in a total of 46 adult patients with acute traumatic spinal cord injury.

 

The Vall d'Hebron, Virgen del Rocío and CHUAC hospitals all have specialized units for the treatment and rehabilitation of spinal cord injuries, as well as advanced neurosurgical services which are suitable for cell transplantation. The specialists of the three institutions have actively participated in the design of the trial, which was recently presented at the IV International Spinal Cord Repair Meeting (ISCORE 2017).

"This is a study of major importance on the development of spinal cord injury in the first few hours, when the best results can be achieved; it sets in motion a model of care based on early intervention in the inflammatory process," says Dr. Miguel Ángel González Viejo, one of the principal investigators of the study and head of the Rehabilitation Service of the Vall d'Hebron Hospital.

About Ferrer

Founded in 1959, Ferrer is an international Barcelona-based pharmaceutical company, with 19 international subsidiaries and a presence in more than 115 countries. Ferrer carries out activities throughout the entire value chain, from R&D to international marketing, in the pharmaceutical, health, fine chemicals and food sectors, key areas for contributing to people’s health and wellbeing. Ferrer's strong commitment to innovation is reflected in a strategy based on collaborations and alliances with public research groups and biotechnology companies, both through a specialized unit, Ferrer Advanced Biotherapeutics, and by interests in European and American biotechnology companies. www.ferrer.com

About Histocell

Histocell is a biopharmaceutical company, part of the Noray Biosciences Group, which specializes in developing innovative medical devices and cell therapy medicinal products for application in regenerative medicine. Histocell currently has a highly qualified team of 30 specialists and production facilities certified by the Spanish Medicines Agency (AEMPS) for the manufacture of cell therapy drugs. Histocell’s technology is based on the use of adult stem cells applied alone or in combination with new generation biomaterials, through which it has consolidated its position in the development of advanced cell therapy and tissue engineering drugs. www.histocell.com