Monthly Archives: August 2013

imageBBC News and a host of other media outlets are featuring an exciting breakthrough in the repair of spinal cord injuries in paralysed rats. The rats have regained bladder control, a major issue for people living with spinal cord injury, in response to nerve cell transplants alongside a series of injections of chondroitinase.

The project led by Dr Jerry Silver of Case Western Reserve Medical School, Cleveland, Ohio, builds on the findings of a previous project funded by Spinal Research which saw this approach restore independent breathing in rats. An interesting side effect they noted during the original work was the change in bladder function, which prompted the project now making headlines.

A major hurdle in spinal cord repair is the scar tissue that forms at the site of an injury. This new project’s use of chondroitinase, known to breakdown scarring, in addition to the graft of nerve tissue on the injured spinal cord means that injured nerve cells could regrow – some as long as 2cm. As a result the rats regained bladder function meaning that they could urinate unaided.

Dr Mark Bacon, Director of Research at Spinal Research commented:

“It is increasingly evident that if we can establish better communication between the cord above the injury and the cord below, as Silver and colleagues have, we can engage with an intelligent cord that can make use of even rudimental signals and turn them into functionally useful activities. Coordinated bladder function has enormous beneficial consequences for people with spinal cord injury and this is extremely encouraging work showing we are going in the right direction.”

It is hoped that this approach or similar will eventually be used to help people living with paralysis regain independent bladder control.

January 23, 2013 – Doctors at The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, performed the first-ever Food and Drug Administration approved Schwann cell transplantation in a patient with a new spinal cord injury. The procedure, performed at the University of Miami/Jackson Memorial Medical Center, is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.

“This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. This trial, and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said neurosurgeon Barth Green, M.D., Co-Founder and Chairman of The Miami Project, and Professor and Chair of Neurological Surgery. “The Miami Project team includes hundreds of scientists, clinicians, and technicians who have joined hands to make the ‘impossible possible,’ for which this trial is a key goal and dream now being realized. This achievement reaffirms that the tens of millions of dollars and the incalculable work hours were well invested in this first of a kind human Schwann cell project.”

Led by W. Dalton Dietrich, Ph.D., Scientific Director of The Miami Project and Professor of Neurological Surgery, Neurology and Cell Biology & Anatomy, the Schwann cell clinical trial team at The Miami Project is composed of a multi-disciplinary group of basic science and clinical faculty members, scientific staff, and regulatory personnel focused on advancing the trial. The transplantation procedure was conducted by the Principal Investigators of the trial, Drs. Allan Levi, M.D., Ph.D., Professor of Neurological Surgery, Orthopedics, and Rehabilitation, and James Guest, M.D., Ph.D., Associate Professor of Neurological Surgery. The patient had a neurologically complete thoracic spinal injury and received the transplantation of autologous Schwann cells about four weeks post-injury. There have been no adverse events and the team is moving forward with the trial.

“As a basic scientist, the hope is always to increase knowledge and discovery,” said Dietrich. “Not every day are you able to see that translated into the clinical realm with the hopes of bettering the lives of those suffering, so this Phase I clinical trial is a vital step for the field of SCI research, and for The Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies to target spinal cord injuries.”

The Miami Project clinical trial will enroll a total of eight participants with acute thoracic SCI. Newly injured patients brought to the trauma center would have to meet the stringent inclusion criteria. The participants will undergo a biopsy of a sensory nerve in one leg to obtain the tissue from which to grow their own Schwann cells. The Schwann cells are then grown in a state-of-the art culturing facility for three to five weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are surgically transplanted into the injury site, participants will be 26-42 days post-injury.

All procedures will be conducted at UM/Jackson and The Miami Project to Cure Paralysis, with colleagues at the University of Miami Miller School of Medicine. Each participant will be followed intensively for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity will be evaluated. It is expected that it could be two to three years from the time the first subject is enrolled until the final subject is one year post-transplantation. All participants will continue to be monitored for an additional four years under a separate clinical protocol. This Phase I trial is the foundation upon which The Miami Project will develop future cell transplant trials targeting different types of injuries, times post-injury, and therapeutic combinations.


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Nerve cells ‘re-grown’ in rats after spinal injuryBy Helen Briggs

BBC News
Nerve regeneration in the rat Nerve regeneration in the rat Continue reading the main story
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US scientists say they have made progress in repairing spinal cord injuries in paralysed rats.

Rats regained some bladder control after surgery to transplant nerve cells into the spinal cord, combined with injections of a cocktail of chemicals.

The study, published in the Journal of Neuroscience, could raise hopes for one day treating paralysed patients.

But UK experts say it will take several years of research before human clinical trials can be considered.

Scientists have tried for decades to use transplants of nerve cells to restore function in paralysed animals by bridging the gap in the broken spinal cord.

However, coaxing the cells to grow and form new connections has proved elusive.

One problem is the growth of scar tissue as the body’s responds to injury, which seems to block cell regeneration.

Continue reading the main story

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If we can show in a larger animal that our technique works and does no additional harm I see no reason why we couldn’t move rapidly in humans”
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Dr Jerry Silver

Case Western Reserve Medical School, Cleveland, Ohio

US scientists carried out complex surgery to transplant nerves from the rodents’ ribs into the gap in the middle of their spinal cord.

They also used a special “glue” that boosts cell growth together with a chemical that breaks down scar tissue in an attempt to encourage the nerve cells to regenerate and connect up.

The researchers found for the first time that injured nerve cells could re-grow for “remarkably long distances” (about 2cm).

They said that while the rats did not regain the ability to walk, they did recover some bladder function.

Lead author Dr Jerry Silver of Case Western Reserve Medical School, Cleveland, Ohio, said: “Although animals did not regain the ability to walk, they did recover a remarkable measure of urinary control.”

Co-author Dr Yu-Shang Lee of the Cleveland Clinic, Ohio, added: “This is the first time that significant bladder function has been restored via nerve regeneration after a devastating cord injury.”

The findings may help future efforts to restore other functions lost after spinal cord injury.

They also raise hope that similar strategies could one day be used to restore bladder function in people with severe spinal cord injuries.

Dr Silver said further animal experiments will be needed to see if the technique could work in humans.

He told BBC News: “If we can show in a larger animal that our technique works and does no additional harm I see no reason why we couldn’t move rapidly in humans.”

‘Remarkable advance’

Commenting on the study, Dr Elizabeth Bradbury of King’s College London said several challenges must be overcome before the therapy can be trialled in patients.

“There are a number of challenges before this therapy can be brought to the clinic,” she said.

“Nevertheless this is a remarkable advance which offers great hope for the future of restoring bladder function to spinal injured patients and if these challenges can be met we could be reaching clinical trials within three to five years.”

Dr John Williams, head of neuroscience and mental health at the Wellcome Trust, said the implications for people are not yet clear.

“This is one of a number of ways that one can approach restoration of bladder function in paralysed patients, but careful studies will be needed to optimise which of the technologies under investigation might be of most benefit to patients.”