Neuroplast has enrolled its first patient in a Phase II clinical trial to evaluate efficacy of its transformative Neuro-Cells treatment that aims to prevent further damage to the central nervous system after sustaining acute traumatic spinal cord injury (TSCI).
The trial is conducted in collaboration with Hospital Nacional de Parapléjicos (Toledo, Spain). Recently, Neuroplast announced positive clinical Phase I results with Neuro-Cells for the treatment for TSCI and also secured €10 million which will go towards obtaining conditional EMA market approval.
According to the company, Neuro-Cells uses a patient’s own stem cells to prevent (further) loss of function during the acute phase after sustaining damage to the spinal cord, to preserve function, mobility and independence.
The Phase II clinical trial is being conducted by principal investigators Antonio Oliviero and Jörg Mey of Hospital Parapléjicos (Toledo, Spain).
The study is a randomised and placebo-controlled trial, with an early and late intervention cross-over design. The intervention group receives Neuro-Cells in the sub-acute phase after sustaining trauma, with six months’ follow-up to their primary endpoints. The placebo group will receive a placebo at first, but will be treated with Neuro-Cells after the initial six-month follow-up period. The multi-facetted follow-up for both groups include standardised and validated outcome measures on motor and sensory function and multiple blood and cerebrospinal fluid measurements.
“After having worked in the field of spinal cord injury for almost twenty years, I am happy to contribute to establishing the role of cell transplantation in the functional recovery of individuals with spinal cord injury”, said Oliviero. “I am excited to be a part of this new step in research, together with Neuroplast.”
The trial will involve 16 patients that will be included six to eight weeks after sustaining trauma to the spinal cord.
Neuroplast CEO, Johannes de Munter, added: “The start of this Phase II trial marks another important milestone in our mission to bring back perspective to people who suffer from neurodegenerative diseases for which no effective treatments are available.”