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In 2021, an in-patient study of ten patients with Traumatic Spinal Cord Injury (TSCI), executed in collaboration with Hospital Nacional de Parapléjicos de Toledo, confirms safety and tolerability and the absence of product-related adverse effects.

 

  • The Phase I study evaluates the safety and tolerability of the Neuro-Cells® stem cell preparation for intrathecal application. Ten patients with Traumatic Spinal Cord Injury, who sustained the trauma between one and five years ago and suffered either a partial or a full lesion, received the Neuro-Cells® treatment, manufactured from the patient’s own bone marrow, led by principal investigators Antonio Oliviero, MD, PhD and Prof. Dr. Jörg Mey.
     

  • The safety study started in November 2020 and has reached its endpoint in October 2021. No serious safety concerns or product-related adverse events have occurred during the study.
     

  • In addition, the study demonstrated clinical feasibility to collect, manufacture and treat patients in Spain with a fresh autologous stem cell preparation derived from bone marrow, from our GMP (Good Manufacturing Practice) production facility in The Netherlands, within 48 hours.

P H A S E  I  C L I N I C A L  T R I A L

In collaboration with: Hospital Nacional de Parapléjicos, Toledo, Spain.