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Neuroplast Successfully Wraps Up Patient Recruitment for Phase II Clinical Trial Addressing Traumatic Spinal Cord Injuries

Friday, September 08, 2023

Neuroplast, a Dutch clinical-stage biotechnology company specializing in cell-based therapies for neurodegenerative diseases, has achieved a significant milestone by completing patient recruitment for its Phase II clinical trial. This trial, employing a randomized, placebo-controlled, and double-blinded design, aims to assess the effectiveness of Neuro-Cells® in treating Traumatic Spinal Cord Injury (TSCI). Initial data highlights a robust safety profile, with no product-related adverse events, and positive feedback from patients regarding tolerability. This collaborative trial involved partnerships with the Hospital Nacional de Parapléjicos in Toledo, Spain, and Rigshospitalet in Copenhagen, Denmark.

Neuro-Cells® is an innovative technology that utilizes a patient's own bone marrow to create a stem cell therapy capable of modulating inflammation and enhancing regeneration within the central nervous system. Administered intrathecally during the sub-acute phase, this personalized therapy aims to preserve and restore function, mobility, and independence.

Led by Principal Investigators Antonio Oliviero, MD, PhD, and Prof. Jörg Mey from Hospital Parapléjicos in Toledo, Spain, alongside Professor Fin Biering-Sørensen and MD, PhD Claus Andersen from Rigshospitalet in Copenhagen, Denmark, this multi-center study employed a randomized, double-blinded, placebo-controlled design with an early and late intervention crossover. Patients in the intervention group received Neuro-Cells® during the sub-acute phase following trauma and underwent a six-month follow-up to assess primary endpoints. Patients in the placebo group initially received a placebo but are scheduled to receive Neuro-Cells® after the initial six-month follow-up. The evaluation for both groups included standardized measures for motor and sensory function, as well as multiple blood and cerebrospinal fluid assessments. Patients found the intervention to be straightforward and compatible with their daily routines, requiring minimal adjustments or changes in medication.

Dr. Antonio Oliviero, Principal Investigator at Hospital Nacional de Parapléjicos de Toledo, Spain, expressed satisfaction with the treatment, noting that patients found it easy, feasible, and safe.

Prof. Fin Biering-Sørensen, Principal Investigator at Rigshospitalet, Denmark, underscored the project's significance in the quest for a cure for spinal cord injury, highlighting its potential as a promising step forward, especially given that current treatments primarily focus on symptom management and complications associated with spinal cord injury.

The trial involved a total of 16 patients who were enrolled six to ten weeks after experiencing spinal cord trauma and was conducted with official approvals from Spanish and Danish medical ethics committees and regulatory authorities.

Johannes de Munter, CEO of Neuroplast, emphasized the significance of this achievement, bringing them closer to providing an effective treatment for traumatic spinal cord injury. He also reaffirmed the exceptional safety and tolerance profile of Neuro-Cells®.

Furthermore, preliminary research 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, and ongoing research is exploring additional potential applications. Neuroplast is open to discussions regarding investment opportunities to advance clinical pathways for a wider range of central nervous system conditions, including traumatic brain injury.

 

Source:prnewswire.co.uk


 

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