Neuroplast successfully completes patient inclusion of Phase II clinical trial for Traumatic Spinal Cord Injury

• 16 patients have been enrolled in a multicenter international, randomized, placebo-controlled, double-blinded Phase II clinical trial
• Goal: to determine the effect size of Neuro-Cells®, a stem-cell treatment for Traumatic Spinal Cord Injury (TSCI)
• Confirmed excellent safety and tolerability of Neuro-Cells®
• Preclinical evidence showcases Neuro-Cells® potential in other indications, including traumatic brain injury
• Primary outcomes expected in February 2024, full study completion projected in August 2024

Geleen, The Netherlands, 7 September 2023 – Neuroplast, a Dutch clinical-stage biotech, focusing on cell-based treatments for neurodegenerative diseases, has successfully completed patient inclusion of its Phase II randomized placebo-controlled double-blinded clinical trial to evaluate the effect size of Neuro-Cells® for Traumatic Spinal Cord Injury (TSCI).  Preliminary data indicate an excellent safety profile due to the complete absence of product related adverse events. Furthermore, patient feedback confirms excellent tolerability. The trial is conducted in collaboration with Hospital Nacional de Parapléjicos in Toledo, Spain, and Rigshospitalet in Copenhagen, Denmark.

The Neuro-Cells® technology platform uses the patient’s own bone marrow to create a stem cell treatment that modulates inflammation and improves regeneration potential in the central nervous system. Neuro-Cells® are administered intrathecally to patients in the sub-acute stage. This autologous treatment aims to preserve and restore function, mobility, and therefore independence.

Double-blinded, randomized, placebo-controlled multi-center study

The trial was conducted by Principal Investigators Antonio Oliviero, MD, PhD and Prof. Jörg Mey from Hospital Parapléjicos in Toledo, Spain, as well as Professor Fin Biering-Sørensen and MD, PhD Claus Andersen from Rigshospitalet in Copenhagen, Denmark.

The study is a randomized, double-blinded and placebo-controlled trial, with an early and late intervention cross-over design. The intervention group received Neuro-Cells® in the sub-acute phase after sustaining trauma, with six months follow-up to their primary endpoints. The placebo group received a placebo at first but have been or will be treated with Neuro-Cells® after the initial six-month follow-up period. The multi-faceted follow-up for both groups includes standardized and validated outcome measures on motor and sensory function and multiple blood and cerebrospinal fluid measurements. Next to the absence of product related adverse events, the patients describe the intervention as easy and feasible as it does not require significant changes in daily living or medication intake.

Antonio Oliviero, MD, PhD, Principal Investigator at Hospital Nacional de Parapléjicos de Toledo, Spain, states:

“In our collaboration with Neuroplast to establish the role of cell transplantation in the recovery of individuals with spinal cord injury, it is great to hear that patients are pleased with the treatment that they experience as easy, feasible and safe.”

Fin Biering-Sørensen, MD, PhD, Principal investigator at Rigshospitalet, Denmark, adds:

“For decades we have been seeking a cure for spinal cord injury. This project may be one step on that road, which is very exciting, due to the fact that so far, we have only been able to treat the symptoms and complications caused by the spinal cord injury.”

In total, the trial involves 16 patients that were included six to ten weeks after sustaining trauma to the spinal cord.

The trial is conducted under official approval from the Spanish and Danish medical ethical committees and competent authorities.

Neuroplast CEO Johannes de Munter concludes:

“This milestone takes us one step closer to offering an effective treatment for patients suffering from traumatic spinal cord injury. We are especially glad to see further confirmation of the excellent tolerability and safety of our Neuro-Cells® product”

Potential relevance to other neurological conditions

Preclinical evidence suggests that the Neuro-Cells® treatment may have broader applications in addressing various neurodegenerative diseases. Neuroplast has obtained orphan disease designations for traumatic spinal cord injury and frontotemporal dementia. Ongoing research efforts are actively exploring additional potential applications.

Neuroplast is open to discussing investment opportunities aimed at advancing the clinical pathways for addressing a broader range of conditions affecting the central nervous system, including traumatic brain injury.