- 16
patients have been enrolled in a multicenter international, randomized,
placebo-controlled, double-blinded Phase II clinical trial
- Goal:
to determine the effect size of Neuro-Cells®, a stem-cell treatment
for Traumatic Spinal Cord Injury (TSCI)
- Confirmed
excellent safety and tolerability of Neuro-Cells®
- Preclinical
evidence showcases Neuro-Cells® potential in other indications,
including traumatic brain injury
- Primary
outcomes expected in February 2024, full study completion projected in
August 2024
Neuroplast, a Dutch clinical-stage biotech,
focusing on cell-based treatments for neurodegenerative diseases, has
successfully completed patient inclusion of its Phase II randomized
placebo-controlled double-blinded clinical trial to evaluate the effect
size of Neuro-Cells® for Traumatic Spinal Cord Injury (TSCI).
Preliminary data indicate an excellent safety profile due to the complete
absence of product related adverse events. Furthermore, patient feedback
confirms excellent tolerability. The trial is conducted in collaboration
with Hospital Nacional de Parapléjicos in Toledo, Spain, and Rigshospitalet
in Copenhagen, Denmark.
The Neuro-Cells®
technology platform uses the patient’s own bone marrow to create a stem
cell treatment that modulates inflammation and improves regeneration
potential in the central nervous system. Neuro-Cells® are administered
intrathecally to patients in the sub-acute stage. This autologous treatment
aims to preserve and restore function, mobility, and therefore
independence.
Double-blinded,
randomized, placebo-controlled multi-center study
The trial was
conducted by Principal Investigators Antonio Oliviero, MD, PhD and Prof.
Jörg Mey from Hospital Parapléjicos in
Toledo, Spain, as well as Professor Fin Biering-Sørensen and MD, PhD Claus
Andersen from Rigshospitalet in Copenhagen, Denmark.
The study is a
randomized, double-blinded and placebo-controlled trial, with an early and
late intervention cross-over design. The intervention group received
Neuro-Cells® in the sub-acute phase after sustaining trauma, with six
months follow-up to their primary endpoints. The placebo group received a
placebo at first but have been or will be treated with Neuro-Cells® after
the initial six-month follow-up period. The multi-faceted follow-up for
both groups includes standardized and validated outcome measures on motor
and sensory function and multiple blood and cerebrospinal fluid
measurements. Next to the absence of product related adverse events, the
patients describe the intervention as easy and feasible as it does not
require significant changes in daily living or medication intake.
Antonio Oliviero,
MD, PhD, Principal Investigator at Hospital Nacional de Parapléjicos de
Toledo, Spain, states:
“In our collaboration with
Neuroplast to establish the role of cell transplantation in the recovery of
individuals with spinal cord injury, it is great to hear that patients are
pleased with the treatment that they experience as easy, feasible and
safe.”
Fin
Biering-Sørensen, MD, PhD, Principal investigator at Rigshospitalet,
Denmark, adds :
“For decades we have been seeking a cure for spinal cord
injury. This project may be one step on that road, which is very exciting,
due to the fact that so far, we have only been able to treat the symptoms
and complications caused by the spinal cord injury.”
In total, the
trial involves 16 patients that were included six to ten weeks after
sustaining trauma to the spinal cord.
The trial is
conducted under official approval from the Spanish and Danish medical
ethical committees and competent authorities.
Neuroplast CEO
Johannes de Munter concludes:
“This milestone takes us one step
closer to offering an effective treatment for patients suffering from
traumatic spinal cord injury. We are especially glad to see further
confirmation of the excellent tolerability and safety of our Neuro-Cells®
product”
Potential relevance
to other neurological conditions
Preclinical evidence
suggests that the Neuro-Cells® treatment may have broader applications in
addressing various neurodegenerative diseases. Neuroplast has obtained
orphan disease designations for traumatic spinal cord injury and
frontotemporal dementia. Ongoing research efforts are actively exploring
additional potential applications.
Neuroplast is open to discussing investment
opportunities aimed at advancing the clinical pathways for addressing a
broader range of conditions affecting the central nervous system, including
traumatic brain injury.
=== E N D S ===
About Traumatic
Spinal Cord Injury (TSCI)
Acute TSCI
causes incurable impairment to the spinal cord, affecting approximately
12,000 people across Europe and 17,000 across the USA annually. The damage
or trauma interrupts communication of the brain with the body regions below
the site of injury. Spinal cord injuries are mainly caused by accidents and
- in most of the cases - result in life-long loss of control of motor
functions and sensations. After the primary injury to the spinal cord, a
cascade of events leads to progressive loss of tissue which may further
deteriorate the patient’s prognosis. Current treatment approaches for TSCI
are only symptomatic, leaving the underlying pathophysiology unchanged.
TSCI has a
serious impact on the quality of life of patients, with severe implications
on mobility and loss of independence. In addition, TSCI creates a lifetime
financial burden for patients, payors, healthcare systems and societies at
large.
About Neuro-Cells®
Neuro-Cells® is
a transformative platform treatment under GMP. It contains a non-substantially
manipulated bone marrow-derived integrated mixture of stem cells including
hematopoietic and mesenchymal stem cells, manufactured from a patient’s own
bone marrow (donor and receiver are the same person). Inflammatory inducing
components and pathogens are removed during this process.
About Neuroplast
Neuroplast is a
Dutch stem cell technology company focusing on fast-track development
programs using autologous cell products for treatment of neurodegenerative
diseases, with the aim of giving back perspective to people who suffer from
those conditions.
The company was
founded in August 2014 by physician Johannes de Munter and neurologist Erik
Wolters. Current funders are Lumana Invest, Brightlands Venture Partners,
LIOF and the Netherlands Enterprise Agency. Neuroplast is located in The
Netherlands.
For more
information, please visit www.neuroplast.com
About Hospital de
Parapléjicos, Toledo, Spain
Hospital
Nacional de Parapléjicos is the reference public hospital in Spain for the
treatment of spinal cord injury, recognized by the Ministry of Health of
the Government of Spain.
About
Rigshospitalet, Copenhagen, Spain
Rigshospitalet
is one of the two Danish national centers offering highly specialized
treatment, rehabilitation and care of individuals with spinal cord
lesions.
About Lumana Invest
Investment
company Lumana was established by entrepreneurs and unique due to not
having a predetermined investment horizon. The Lumana founders showcase
strong commitment to their portfolio companies by actively supporting
management in strategic decision making.
About Brightlands
Venture Partners
Brightlands
Venture Partners (BVP) is the fund manager of Chemelot Ventures and is a
so-called ecosystem investor. BVP invests in companies benefiting from and
contributing to the Brightlands campuses in the south of The Netherlands.
Other funds under management are BVP Fund IV, Brightlands Agrifood Fund and
Limburg Ventures. The funds of BVP focus on sustainability and health;
together the funds have made 50 investments.
About LIOF
LIOF is the
regional development agency for Limburg and supports innovative
entrepreneurs with advice, network and financing. Together with
entrepreneurs and partners, LIOF is working towards a smarter, more
sustainable and healthier Limburg by focusing on the transitions of energy,
circularity, health and digitalization.
About The Netherlands Enterprise Agency
The
Netherlands Enterprise Agency operates under the auspices of the Dutch
Ministry of Economic Affairs and Climate Policy. It facilitates
entrepreneurship, improves collaborations, strengthens positions and helps
realize national and international ambitions with funding, networking,
know-how and compliance with laws and regulations.
Forward
looking statements
All statements
other than statements of historical facts, including the statements about
the clinical and therapeutic potential and future clinical milestones of
Neuro-CellsÒ, the indications we
intend to pursue and our possible clinical or other business strategies,
and the timing of these events, are forward-looking statements.
Forward-looking statements can be identified by terms such as “believes”,
“expects”, “plans”, “potential”, “would” or similar expressions and the
negative of those terms. These forward-looking statements are based on our
management’s current beliefs and assumptions about future events and on
information currently available to management. Neuroplast B.V. does not
make any representation or warranty, express or implied, as to the improper
use of this article, accuracy, completeness or updated status of
above-mentioned statements. Therefore, in no case whatsoever will
Neuroplast B.V. be legally liable or liable to anyone for any decision made
or action taken in conjunction with the information and/or statements in
this press release or for any related damages.
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