The Phase I study evaluated the safety and tolerability of Neuroplast's Neuro-Cells stem cell preparation for intrathecal application (injection into the spinal canal)
Regenerative stem cell technology company Neuroplast and Hospital Nacional de Parapléjicos de Toledo in Spain, have announced positive clinical Phase I results after an analysis of ten patients suffering from traumatic spinal cord injury (TSCI). The results demonstrate Neuroplast’s Neuro-Cells treatment 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, the company says, helping to potentially 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 treatment, manufactured from the patient’s own bone marrow, led by principal investigators Antonio Oliviero, MD, PhD and Prof Jörg Mey.
The study started in November 2020 and reached its primary endpoint in October 2021. No serious safety concerns or product-related adverse events occurred.
In addition, the company 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 production facility in the Netherlands, within 48 hours.
Antonio Oliviero, principal investigator in the Phase I study, 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, said: “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.”