Regenerative stem cell technology aimed at treating traumatic spinal cord injury is moving closer to reality with enrolment beginning in its Phase II clinical trial.
The pioneering Neuro-Cells® therapy aims to reduce irreversible damage to the central nervous system from secondary inflammation following trauma.
Having produced “positive” Phase I results, the first patient has now been enrolled in Phase II, to evaluate efficacy of the treatment created by Dutch biotech Neuroplast.
Neuroplast also revealed that, in addition to the potential of Neuro-Cells in spinal cord injury, it hopes to attract the funding to expansion into traumatic brain injury (TBI) and Frontotemporal Dementia.
Neuroplast CEO, Johannes de Munter, said: “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.”
The Phase II trial will involve 16 patients who will be included six to eight weeks after sustaining trauma to the spinal cord.
Spanish and Danish authorities have approved a combined Phase II/III clinical trial, which enables a faster development path towards the market.
Dr Antonio Oliviero, principal investigator at Hospital Nacional de Parapléjicos de Toledo, Spain, said: “After having worked in the field of Spinal Cord Injury for almost 20 years, I am happy to contribute to establishing the role of cell transplantation in the functional recovery of individuals with spinal cord injury.
“I am excited to be a part of this new step in research, together with Neuroplast.”
Annually, approximately 29,000 people across Europe and the USA sustain acute TSCI, which can lead to paralysis or other disability.
To help give hope to patients affected by spinal cord injury, Neuroplast – founded in 2014 by physician Johannes de Munter and neurologist Erik Wolters – developed Neuro-Cells, a treatment that uses the 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.
Now in Phase II trial, the study is a randomised and placebo-controlled trial, with intervention group receiving 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.
