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Trials of ONWARD spinal cord therapy deliver early boost

One patient paralysed for years is now moving his arms and toes following ARC Therapy

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Trials of revolutionary ONWARD spinal cord therapy which is set to transform the lives of people living with paralysis are delivering strong early results, with reports of participants regaining movement in their arms and toes. 

ARC Therapy is being trialled in sites around the world, including in the NHS Greater Glasgow and Clyde (NHSGGC) in a first-of-its-kind study in the UK. 

The treatment, developed by ONWARD, uses tiny non-invasive electric pulses to improve connections across the damaged area of the spinal cord, with the ambition of delivering life-changing outcomes through restoring limb function for people who are tetraplegic or paralysed from the neck down. 

The trials, part of the global Up-LIFT study run by ONWARD, are the latest step in the development of the ARC EX and ARC IM technologies, the first of which could be commercially available as early as 2023. 

Dr Mariel Purcell, consultant in spinal injuries at NHSGGC who is leading the study at the Spinal Injuries Unit at the Queen Elizabeth University Hospital, said: “This is a really exciting research project involving a piece of kit that is completely non-invasive.

“We’ve had a lot of interest – from patients and other spinal injuries clinics around the UK, and further afield. We’ve even been contacted by a patient from the south of England, who is prepared to relocate here just to take part in the study.”

Initial results are promising, says Dr Purcell, and are helping to show that the introduction of ARC Therapy earlier in a person’s rehabilitation could deliver significant benefits. 

“One patient who we have treated with the device was injured playing rugby at the age of 16 and had been completely paralysed from the neck down since,” she said. 

“After the treatment, he had no problems with bladder or temperature control, he could move his big toes, and he can use his arms enough to operate a mobile phone.”

The first half of the study involves eight weeks of intensive therapy to optimise upper limb movement and function. During the second phase of the study, participants will receive non-invasive stimulation of the spinal cord in addition to traditional upper limb therapy for a further eight weeks.

The ARC therapy device works by improving the connections between healthy areas by placing electrodes on the skin that activate the nerves below the level of the injury, making the body more receptive to hand and arm movements.

The aim of the treatment is to help people regain some use of their arms and hands, but it may also improve bladder and bowel function, along with blood pressure control and temperature regulation.

NHSGGC said the participants in the study have received all the rehabilitation and treatment currently available and are living as independently as they can. 

The study in Glasgow is recruiting participants until end of the year and it is hoped the final results of the study will be available later next year.

Spinal

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

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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. 

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Groundbreaking spinal cord injury project backed by $24m

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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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ONWARD spinal stimulation tech awarded new patents

The pioneering business moves further towards its goal of bringing its ARC spinal cord therapy to reality

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The development of ONWARD spinal stimulation therapy continues to move towards commercialisation with the business being awarded nine new patents for its pioneering technology. 

ONWARD now has over 310 issued or pending patents covering its therapies to restore movement, independence and health in people living with spinal cord injury. 

Seven of its new patents are in collaboration with leading neuroscience research laboratories at Caltech, UCLA, EPFL and University of Louisville.

It marks the latest step in ONWARD’s journey towards its ARC technology becoming commercial reality, with ambitions for it to be introduced as early as next year. 

“Our many exclusive IP license agreements with the world’s top neuroscience research universities continue to bear fruit, adding to an already impressive IP portfolio of over 300 issued or pending patents,” said Dave Marver, CEO of ONWARD. 

“We are taking full advantage of our first-mover position to secure seminal and strategic intellectual property borne from our own engineering labs or prosecuted in collaboration with others.”

The patents cover a broad range of technologies and activities encompassing ONWARD’s implantable and external technology platforms, ARC IM and ARC EX, and protect key elements of those systems such as lead designs, spinal cord stimulation paradigms, closed-loop control systems and machine learning algorithms. 

The further development of the ARC technology towards commercialisation comes as its Up-LIFT pivotal trial progresses, with 65 people globally now trialling its pioneering stimulation therapy. 

One site, the NHS Greater Glasgow and Clyde (NHSGGC), has already reported significant initial positives from its trial, with some participants regaining movement in their arms and toes. 

ONWARD expects to initially commercialise its technology in the US, Germany, France, UK, Switzerland and the Netherlands.

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