- 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 regenerative stem cell technology 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.
The
current study is focused on Europe. Neuroplast is seeking additional funding to
expand clinical trials for TSCI to other geographies.
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