Neuroplast, a Dutch clinical-stage biotech company, has successfully concluded the patient inclusion for its Phase II clinical trial, focusing on Traumatic Spinal Cord Injury (TSCI). Here are the key details:
- Patient Enrollment: 16 patients have been enrolled in this multicenter international, randomized, placebo-controlled, double-blinded Phase II clinical trial.
- Objective: The trial aims to determine the effect size of Neuro-Cells®, a stem-cell treatment for TSCI. Preliminary data has shown an excellent safety profile with no product-related adverse events. Additionally, patient feedback has confirmed the treatment’s excellent tolerability.
- Collaboration: The trial is a collaboration between Hospital Nacional de Parapléjicos in Toledo, Spain, and Rigshospitalet in Copenhagen, Denmark.
- Neuro-Cells® Technology: This platform uses the patient’s bone marrow to create a stem cell treatment that can modulate inflammation and enhance regeneration potential in the central nervous system. The treatment aims to preserve and restore function, mobility, and independence.
- Trial Design: The study is randomized, double-blinded, and placebo-controlled, with an early and late intervention cross-over design. The intervention group received Neuro-Cells® in the sub-acute phase post-trauma, with a six-month follow-up. The placebo group initially received a placebo but will be treated with Neuro-Cells® after the initial six-month follow-up.
- Feedback from Investigators: Antonio Oliviero, MD, PhD, Principal Investigator at Hospital Nacional de Parapléjicos de Toledo, Spain, expressed satisfaction with the treatment’s ease and safety. Similarly, Fin Biering-Sørensen, MD, PhD, Principal investigator at Rigshospitalet, Denmark, highlighted the potential of this project as a step towards finding a cure for spinal cord injury.
- Future Outlook: Primary outcomes from the trial are expected in February 2024, with the full study completion projected for August 2024. Additionally, preclinical evidence suggests that Neuro-Cells® treatment might have broader applications in addressing various neurodegenerative diseases.
Thought-Provoking Questions/Insights:
- How will the results of this Phase II clinical trial impact the future of treatments for Traumatic Spinal Cord Injury?
- Given the potential broader applications of Neuro-Cells® treatment, what other neurodegenerative diseases could benefit from this approach?
- With the collaboration between international hospitals, how will this foster further advancements in the field of neurodegenerative disease research?