In 2021, an inpatient study of ten patients with Traumatic Spinal Cord Injury (TSCI), confirmed 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. The following results were observed:
No serious safety concerns or product-related adverse events have occurred during the study.
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.
Furthermore, due to stable patient status and known mechanism of action, no clinical outcomes were expected. However:
Three patients reported favourable effect.
- These include improved bowel control, sensory improvements and increased muscle tonus.
One patient improved from a complete lesion to an incomplete lesion.
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.