Dutch stem cell biotech Neuroplast announces successful clinical Phase I trial
with its Neuro-Cells® stem cell treatment for Traumatic Spinal Cord Injury
• 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
Geleen, The Netherlands and Toledo, Spain, 9 November 2021 – 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 own stem cells to prevent (further) loss of function after sustaining TSCI, to potentially limit
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.