Tuesday 9 November 2021, GELEEN, Netherlands
- Positive safety profile and well-tolerated, without product-related adverse effects
- Demonstrated clinical feasibility to collect, manufacture and treat Spanish patients from its Dutch GMP production facility
- Preparation for randomized, placebo-controlled, international multi-center Phase II study in sub-acute patients
- Orientation on additional funding to expand clinical trials to other geographies
Dutch clinical phase biotech company Neuroplast and Hospital Nacional de Parapléjicos de Toledo in Spain, today announced positive clinical Phase I results after analysis of ten patients suffering from Traumatic Spinal Cord Injury (TSCI). Data demonstrate that Neuroplast's investigational stem cell treatment Neuro-Cells® appears to be safe and well-tolerated, without product-related adverse events. The transformative treatment uses the patient's stem cells to prevent (further) loss of function after sustaining TSCI, to potentially limit the loss of mobility and independence of otherwise life-long impairment.
The Phase I study evaluated the safety and tolerability of the Neuro-Cells® stem cell preparation for intrathecal application (injection into the spinal canal). Ten patients with spinal cord injury, who sustained the trauma between one and five years ago and suffered either an incomplete or a complete 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 reached its primary endpoint in October 2021. No serious safety concerns or product-related adverse events have occurred during the study.
In addition, Neuroplast demonstrated clinical feasibility to collect, manufacture and treat patients in Spain with a fresh autologous stem cell preparation derived from bone marrow, from its GMP (Good Manufacturing Practice) production facility in the Netherlands, within 48 hours.
Antonio Oliviero, MD, PhD, Hospital Nacional de Parapléjicos, Toledo, Spain, and principal investigator in the Phase I study, comments:
"I'm really enthusiastic about the prospects of this therapy and what it means for the future treatment of patients with TSCI. Neuro-Cells® might be a game-changer."
Neuroplast CEO Johannes de Munter, adds:
Proving the safety of our autologous Neuro-Cells® treatment is an important step in the development of a treatment for acute TSCI patients, as the absence of product-related adverse events in the clinical phase I study highlights its inherent safety. The functional, psychological, and financial impacts of traumatic spinal cord injury are broad, and we are committed to advance our treatment for patients worldwide as soon as possible."
With the completion of the Phase I safety trial, Neuroplast will finalize preparation for the start of a randomized, placebo-controlled, international multi-center Phase II study. This study will evaluate the efficacy and safety of treatment in sub-acute patients.
The current study is focused on Europe. Neuroplast is seeking additional funding to expand clinical trials for TSCI to other geographies.
( original url )
back to News