A clinical trial of regenerative stem cell technology which could be “game changing” for people living with spinal cord injury has produced “positive” Phase I results, its creators have announced.
Dutch stem cell technology company Neuroplast, working alongside Hospital Nacional de Parapléjicos de Toledo in Spain, has enrolled ten patients with traumatic spinal cord injury (TSCI) in its trial.
The Phase I study evaluated the safety and tolerability of the Neuro-Cells treatment, in terms of stem cell preparation for intrathecal application. The transformative therapy uses the patient’s own stem cells to prevent further loss of function, to potentially limit loss of mobility and enable independence of otherwise life-long impairment.
The trial’s participants all sustained their injury between one and five years ago and suffered either an incomplete or a complete lesion, and received the Neuro-Cells treatment, manufactured from the patient’s own bone marrow.
Now, reporting the outcomes of Phase I, Neuroplast says its trial “appears to be safe and well tolerated, without product-related adverse events”.
The safety study started in November 2020 and reached its primary endpoint in October 2021. No serious safety concerns or product-related adverse events have occurred during the study, said Neuroplast.
In addition, 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.
Preparation is now underway for a randomised, placebo-controlled, international multi-centre Phase II study in sub-acute patients.
“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,” says Neuroplast CEO, Johannes de Munter.
“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.”
Dr Antonio Oliviero, of the Hospital Nacional de Parapléjicos and principal investigator in the Phase I study, adds: “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.”
