Dutch biotech company, Neuroplast, and the Hospital Nacional de Parapléjicos de Toledo in Spain have announced positive clinical Phase I results after analysis of ten patients suffering from traumatic spinal cord injury (TSCI), with data demonstrating that its investigational stem cell treatment, Neuro-Cells, appears to be safe and well tolerated, without product-related adverse events.
The treatment uses the patient’s own stem cells to prevent further loss of function after sustaining TSCI, in an effort to limit loss of mobility and independence of otherwise life-long impairment.
The Phase I study evaluated the safety and tolerability of the Neuro-Cells stem cell preparation for intrathecal application (injection into the spinal canal). Ten patients with spinal cord injury, who sustained the trauma between one and five years ago and suffered either an incomplete or a complete lesion, received the Neuro-Cells treatment, manufactured from the patient’s own bone marrow.
The safety study, which was led by principal investigators Antonio Oliviero (Toledo, Spain) and Jörg Mey (Maastricht, Netherlands) started in November 2020 and reached its primary endpoint in October 2021. No serious safety concerns or product-related adverse events occurred during the study.
Oliviero said: “I’m really enthusiastic about the prospects of this therapy and what it means for the future treatment of patients with TSCI. Neuro-Cells might be a game-changer.”
Neuroplast CEO, Johannes de Munter, added: “Proving the safety of our autologous Neuro-Cells treatment is an important step in the development of a treatment for acute TSCI patients, as the absence of product-related adverse events in the clinical Phase I study highlights its inherent safety. The functional, psychological, and financial impacts of traumatic spinal cord injury are broad, and we are committed to advance our treatment for patients worldwide as soon as possible.”
With the completion of the Phase I safety trial, Neuroplast will finalise preparation for the start of a randomised, placebo-controlled, international multicentre Phase II study. This study will evaluate the efficacy and safety of treatment in sub-acute patients.