A clinical trial of regenerative stem cell technology which could be “game changing” for people living with spinal cord injury has produced “positive” Phase I results, its creators have announced.
Dutch stem cell technology company Neuroplast, working alongside Hospital Nacional de Parapléjicos de Toledo in Spain, has enrolled ten patients with traumatic spinal cord injury (TSCI) in its trial.
The Phase I study evaluated the safety and tolerability of the Neuro-Cells treatment, in terms of stem cell preparation for intrathecal application. The transformative therapy uses the patient’s own stem cells to prevent further loss of function, to potentially limit loss of mobility and enable independence of otherwise life-long impairment.
The trial’s participants all sustained their injury between one and five years ago and suffered either an incomplete or a complete lesion, and received the Neuro-Cells treatment, manufactured from the patient’s own bone marrow.
Now, reporting the outcomes of Phase I, Neuroplast says its trial “appears to be safe and well tolerated, without product-related adverse events”.
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, said Neuroplast.
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.
Preparation is now underway for a randomised, placebo-controlled, international multi-centre Phase II study in sub-acute patients.
“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,” says Neuroplast CEO, Johannes de Munter.
“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.”
Dr Antonio Oliviero, of the Hospital Nacional de Parapléjicos and principal investigator in the Phase I study, adds: “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.”
Clinical trial gives hope to spinal cord injury patients
If successful animal studies translate into patients, NVG-291 could be set to redefine the treatment of spinal cord injury
A revolutionary treatment designed to help redefine the future of people with spinal cord injury (SCI) is to embark on a clinical trial.
The NVG-291 treatment has previously indicated its huge potential through two independent studies, which resulted in significant recovery in mobility and/or bladder function in animals with spinal cord injury.
Now, NervGen Pharma, the biotech company behind NVG-291, has announced a Memorandum of Understanding the Shirley Ryan AbilityLab, with the intention of progressing the first clinical trial of the treatment.
The single site trial is expected to start in the second half of this year and will assess the safety and effect of NVG-291 in treating acute and subacute, as well as chronic SCI, patients.
NVG-291 is based on the by Dr Jerry Silver at Case Western Reserve University of a class of molecules (chondroitin sulphate proteoglycans, or CSPGs) that are up-regulated in response to nervous system damage and that inhibit repair.
NVG-291 was designed to bypass this inhibition by CSPGs, thereby enhancing the body’s natural repair mechanisms, including plasticity, regeneration and remyelination.
“We have been following Dr Silver’s work for years and are very excited to be the first centre working with NervGen on this important spinal cord injury study,” said Dr Monica A. Perez, scientific chair of the Arms + Hands Lab at Shirley Ryan AbilityLab.
“One of the important aspects of this single-centre, placebo-controlled trial is the use of advanced electrophysiology to assess transmission in cortical and subcortical neuronal pathways as well as behavioural outcomes.
“The ability of NVG-291 to demonstrate meaningful recovery in motor function, sensory function and bladder control in animal models is exceptional.
“If these results translate to patients, NVG-291 could redefine the treatment of spinal cord injury.”
“NervGen and Shirley Ryan AbilityLab are planning a very unique and intriguing trial design, into which I have been fortunate to provide input,” stated Dr James Guest, professor of neurological surgery at the University of Miami and member of NervGen’s Spinal Cord Injury Clinical Advisory Board.
“The rationale to include acute and chronic patients in a study underscores the broad potential of the mechanism of NVG-291 in SCI.
“Using Shirley Ryan AbilityLab in a single-centre study that implements advanced electrophysiological techniques to monitor connectivity across the site of injury will allow reproducible testing to explore NVG-291’s effects on motor recovery, possibly shaping the impact of subsequent studies.
“Partnering with Shirley Ryan AbilityLab, a leading institution in spinal cord injury research and management of patients with spinal cord injury, is an exceptional opportunity for NervGen.”
World-first stem cell trial for spinal cord injury
Keio University hailed the implant of cells as a ‘huge step forward’ in the quest to cure paralysis
The world’s first successful transplant of stem cells in a patient with a spinal cord injury (SCI) has been hailed as a “huge step forward” in efforts to cure paralysis.
Surgeons at Tokyo’s Keio University are studying whether induced pluripotent stem (iPS) cells can be used to treat SCI.
And it has been announced than in the first step in the trial, more than two million iPS-derived cells have been implanted into a patient’s spinal cord in an operation which took place last month.
Keio University Professor Masaya Nakamura, who leads the research, said this marked a “huge step forward” but there remains “lots of work to be done” before the treatment can be put to use.
iPS cells are created by stimulating mature, already specialised, cells back into a juvenile state.
They can then be prompted to mature into different kinds of cells, with the Keio University study using iPS-derived cells of the neural stem.
The breakthrough follows significant progress in moving closer to finding a cure for paralysis, with tech company ONWARD underway with its international Up-LIFT trial and a groundbreaking project to develop a biomaterial bridge to regrow nerve fibres being backed by a $24m investment.
The initial stage of the Keio University study aims to confirm the safety of the transplant method, the researchers said.
The patient will be monitored by an independent committee for up to three months to decide whether the study can safely continue and others can receive transplants.
The team also hopes to see whether the stem cell implants will improve neurological function and quality of life.
The number of cells implanted into the patient was determined after safety experiments in animals, said the researchers. While they will be monitoring for therapeutic effects, the study’s main goal is to study the safety of injecting the cells, they added.
The study has been planned since 2019, when the Keio University School of Medicine and Keio University Hospital were given clearance to start a clinical study into regenerative medicine for SCI.
However, recruitment to the trial was suspended after research begun in December 2020 due to the COVID-19 pandemic. Patient recruitment for a subsequent trial is expected to resume in April.
Groundbreaking spinal cord injury project backed by $24m
Groundbreaking work will see the development of a biomaterial bridge to help regrow nerve fibres, giving new hope to people living with spinal cord injury (SCI).
A key challenge in treating traumatic spinal cord injury SCI is repairing the gap that is formed when the spine is broken. This gap, typically a few centimetres wide, essentially blocks nerve impulses from getting through, leading to serious health issues that may include paralysis, loss of blood pressure, bladder and bowel control, sexual dysfunction, and chronic pain.
Now a new, multidisciplinary team—aptly named Mend the Gap—is working on a novel approach that may help people with SCI.
The Mend the Gap team recently received $24million from Canada’s New Frontiers in Research Fund 2020 Transformation stream to investigate using biomaterials—and soft gels in particular—to heal the injury.
The soft gel will be injected into the site of the injury to serve as a bridge for growing nerve fibres.
“A biomaterials bridge is compatible with other systems and structures in the body and is minimally disruptive,” explains principal investigator Dr John Madden, a professor of electrical and computer engineering in the faculty of applied science at the University of British Columbia (UBC).
“The soft gel that our team plan to use contains tiny magnetic rods that are aligned using an external magnet, creating guide rails that support the nerve fibres to grow in the right direction, eventually crossing the gap.”
Previous treatments for spinal cord injuries used solid bridges, which have the drawback of risking injury to any remaining healthy nerve fibres and bodily functions, explains co-principal investigator Dr Wolfram Tetzlaff, a professor of surgery and zoology at UBC and director of ICORD, a world-leading centre for spinal cord injury research within the UBC faculty of medicine and the Vancouver Coastal Health Research Institute.
“A soft gel can be moulded into the shapes of the many different lesions seen in the body, and thus provide personalised treatment,” said Dr. Tetzlaff.
“Since the surgery will be minimally invasive, we can potentially see shorter recovery times and minimal damage to the patients.”
Co-principal investigator Dr Dena Shahriari adds that thus far, research in SCI has been largely focused on biomaterials that need to be implanted through invasive surgery.
“Here, we shift the focus to injectable biomaterials to potentially protect any residual function that those living with SCI heavily rely on and treasure,” says Dr Shahriari, a biomaterials scientist and neural engineer, and an assistant professor at UBC’s department of orthopaedics and school of biomedical engineering. She also leads a team at ICORD that develops neuroelectronic devices, sensors and smart biomaterials to interface with biological tissues and provide new capabilities for tissue regeneration and improving organ function.
One reason repairing the spinal cord is so difficult is the presence of scar tissue, so the soft gel will contain drugs that can modify that tissue and revive the nerve fibres. The gel will be injected into the spinal cord by a machine-vision-equipped surgical robot for enhanced precision.
“Every week we admit a new patient whose life has been turned upside down after suffering a spinal cord injury,” says co-principal investigator, Dr Brian Kwon, a professor of orthopaedics at UBC’s faculty of medicine, the Canada Research Chair in Spinal Cord Injury and Dvorak Chair in Spine Trauma.
“It serves as a stark reminder that we have to be pushing the boundaries of science and innovation in initiatives like Mend the Gap to establish novel ways of repairing the injured cord.”
While the primary goal of Mend the Gap is repairing the spinal cord in recently injured individuals, the team does not rule out eventually applying the results to those who have chronic injuries in the future.
The 32-member project includes researchers, engineers and surgeons from Canada, the United States, Europe and Australia. In Canada, the network includes UBC, ICORD, the University of Alberta, Western University, McGill University and University of Toronto.
Co-principal investigator Dr Karen Cheung says the project highlights the unique advantages of bringing together medical and engineering knowledge to tackle the complexity of spinal cord injuries.
“Biomedical engineers play a central role in addressing grand challenges in health, because they analyse, interpret, transform and recombine knowledge and information from all of these domains—materials engineering, electrical engineering, neuroscience, chemistry, physics—to generate new technologies and make impactful discoveries,” says Dr. Cheung, a bioengineering professor at UBC’s school of biomedical engineering.
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