Revolutionary spinal cord stimulation technology pioneered by ONWARD is moving closer to becoming a commercial reality with the completion of enrolment in its pivotal trial.
The Up-LIFT study involved 14 leading spinal cord injury (SCI) sites across the UK, United States, Canada and the Netherlands and will evaluate the safety and effectiveness of the breakthrough ARC Therapy.
The technology will use non-invasive stimulation to treat upper extremity functional deficits in people with chronic tetraplegia, and the study has now reached its target of enrolling 65 people around the world.
One site, the NHS Greater Glasgow and Clyde (NHSGGC), has already reported huge initial positives from its trial, with some participants regaining movement in their arms and toes.
And the completion of enrolment marks the latest milestone in the journey towards commercialisation of ARC Therapy, which could be introduced as early as 2023. ONWARD expects to initially commercialise its technology in the US, Germany, France, UK, Switzerland and the Netherlands.
“The study reached its enrolment objective in under 12 months despite lockdowns, travel restrictions, and other COVID-related challenges,” said Dave Marver, CEO of ONWARD.
“This milestone underscores the SCI community’s enthusiasm for this promising therapy.
“We will now work with determination to prepare submissions to regulatory authorities in the US and Europe so we can bring this important therapy to market for the benefit of people with SCI and their loved ones.”
“For individuals with impaired arm and hand function due to spinal cord injury, improved hand function directly translates into meaningful gains in terms of quality of life – being able to eat, dress or perform other daily life activities,” said Dr Edelle Field-Fote, co-PI of the Up-LIFT trial and director of Spinal Cord Injury Research at Shepherd Center and Professor of Rehabilitation Medicine at Emory University School of Medicine.
“It was very rewarding to take part in this important trial and collaborate with many of the most highly respected SCI rehabilitation centres across the globe.”
“The end of enrolment for this trial marks a significant milestone in bringing non-invasive stimulation for restoring hand and arm function to people living with spinal cord injury,” said Dr Chet Moritz, co-PI of the Up-LIFT trial and associate professor in the Departments of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington in Seattle.
“We are hopeful this study can lead to the broad availability of this important therapy.”
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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