The treatment uses the patient's own stem cells to prevent (further) loss of function after sustaining TSCI, to potentially limit loss of mobility and independence of otherwise life-long impairment. It is administered in the crucial first phase after sustaining TSCI, during which the irreversible impact of TSCI can be radically reduced.
The Phase I study, run with Hospital Nacional de Parapléjicos de Toledo in Spain, 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 treatment, manufactured from the patient's own bone marrow.
The safety study started in November 2020 and reached its primaryendpoint in October 2021. No serious safety concerns or product-related adverse events have occurred during the study.
In addition, Maastricht-based Neuroplast demonstrated clinical feasibility to collect, manufacture and treat patients in Spain with a fresh autologous stem cell preparation derived from bone marrow, from its GMP (Good Manufacturing Practice) production facility in the Netherlands, within 48 hours.
Neuroplast will now finalize preparation for the start of a randomized, placebo-controlled, international multi-center Phase II study to evaluate the efficacy and safety of treatment in sub-acute patients.
Neuroplast is seeking additional funding to expand clinical trials for TSCI to other geographies.
Acute TSCI causes incurable impairment to the spinal cord, affecting approximately 12,000 people across Europe and 17,000 across the US annually.
The damage interrupts communication of the brain with the body regions below the site of injury. Spinal cord injuries are mainly caused by accidents and - in most cases - result in life-long loss of control of motor functions and sensations.
After the primary injury to the spinal cord, a cascade of events leads to progressive loss of tissue which may further deteriorate the patient's prognosis.
Current treatment approaches for TSCI are only symptomatic, leaving the underlying pathophysiology unchanged.