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Neuroplast Completes Phase II Clinical Trial Inclusion for Traumatic Spinal Cord Injury

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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:

  1. How will the results of this Phase II clinical trial impact the future of treatments for Traumatic Spinal Cord Injury?
  2. Given the potential broader applications of Neuro-Cells® treatment, what other neurodegenerative diseases could benefit from this approach?
  3. With the collaboration between international hospitals, how will this foster further advancements in the field of neurodegenerative disease research?

Original Press Release

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