Japan has given a stem cell therapy the “green light” for the treatment of spinal cord injuries in humans.

The country has unique regulations for the approval of regenerative medicines — therapies can be sold even if they show only hints of efficacy, on the condition that follow-up data is collected.

Therefore, four candidates will be selected for a trial, following the approval by Japan’s Health Ministry on Monday. The participants must have sustained a spinal cord injury 2-4 weeks prior, and must have lost mobility and sensory functions as a result. 

The work is being lead by a research group from Keio University. 

Significant progress has been made in the regenerative medicine/CNS space in the last 12 months:

A biodegradable nanoscaffold was developed for the transplantation of stem cells into the spinal cord and was shown to be a viable approach in animal modelsBioengineered spinal discs implanted into goats showed promiseHuman induced pluripotent stem cell-derived neurons grafted into rodents suppressed epileptic seizures

https://www.technologynetworks.com/biopharma/news/japan-approves-stem-cell-therapy-for-spinal-cord-injuries-315803

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Below is an article from 2 years ago, describing what I believe was the first successful trial of stem cells for paralysis caused by spinal injury.

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Experimental stem cell therapy helps paralyzed man regain use of arms and handsThe 21-year-old who suffered a cervical spine injury in March gains significant improvement in his motor function at Keck Hospital of USC

In March 6, just shy of his 21st birthday, Kristopher (Kris) Boesen of Bakersfield suffered a traumatic injury to his cervical spine when his car fishtailed on a wet road, hit a tree and slammed into a telephone pole.

His parents were warned there was a good chance their son would be permanently paralyzed from the neck down. However, they also learned that he could possibly qualify for a clinical study that might help.

Enter Keck Medical Center of USC, which announced that a team of doctors became the first in California to inject its patient with an experimental treatment made from stem cells as part of a multi-center clinical trial.

Charles Liu, director of the USC Neurorestoration Center, led the surgical team, working in collaboration with the Rancho Los Amigos National Rehabilitation Center and Keck Medicine of USC, that injected an experimental dose of 10 million AST-OPC1 cells directly into Boesen’s cervical spinal cord in early April.

“Typically, spinal cord injury patients undergo surgery that stabilizes the spine but generally does very little to restore motor or sensory function,” Liu explained. “With this study, we are testing a procedure that may improve neurological function, which could mean the difference between being permanently paralyzed and being able to use one’s arms and hands. Restoring that level of function could significantly improve the daily lives of patients with severe spinal injuries.”

Two weeks after surgery, Boesen began to show signs of improvement. Three months later, he’s able to feed himself, use his cellphone, write his name, operate a motorized wheelchair and hug his friends and family. Improved sensation and movement in both arms and hands also makes it easier for him to care for himself, and to envision a life lived more independently.

https://news.usc.edu/107047/experimental-stem-cell-therapy-helps-paralyzed-man-regains-use-of-arms-and-hands/

dv said:

 

Japan has given a stem cell therapy the “green light” for the treatment of spinal cord injuries in humans.

The country has unique regulations for the approval of regenerative medicines — therapies can be sold even if they show only hints of efficacy, on the condition that follow-up data is collected.

Therefore, four candidates will be selected for a trial, following the approval by Japan’s Health Ministry on Monday. The participants must have sustained a spinal cord injury 2-4 weeks prior, and must have lost mobility and sensory functions as a result. 

The work is being lead by a research group from Keio University. 

Significant progress has been made in the regenerative medicine/CNS space in the last 12 months:

A biodegradable nanoscaffold was developed for the transplantation of stem cells into the spinal cord and was shown to be a viable approach in animal modelsBioengineered spinal discs implanted into goats showed promiseHuman induced pluripotent stem cell-derived neurons grafted into rodents suppressed epileptic seizures

https://www.technologynetworks.com/biopharma/news/japan-approves-stem-cell-therapy-for-spinal-cord-injuries-315803

—-
Below is an article from 2 years ago, describing what I believe was the first successful trial of stem cells for paralysis caused by spinal injury.

—-

Experimental stem cell therapy helps paralyzed man regain use of arms and handsThe 21-year-old who suffered a cervical spine injury in March gains significant improvement in his motor function at Keck Hospital of USC

In March 6, just shy of his 21st birthday, Kristopher (Kris) Boesen of Bakersfield suffered a traumatic injury to his cervical spine when his car fishtailed on a wet road, hit a tree and slammed into a telephone pole.

His parents were warned there was a good chance their son would be permanently paralyzed from the neck down. However, they also learned that he could possibly qualify for a clinical study that might help.

Enter Keck Medical Center of USC, which announced that a team of doctors became the first in California to inject its patient with an experimental treatment made from stem cells as part of a multi-center clinical trial.

Charles Liu, director of the USC Neurorestoration Center, led the surgical team, working in collaboration with the Rancho Los Amigos National Rehabilitation Center and Keck Medicine of USC, that injected an experimental dose of 10 million AST-OPC1 cells directly into Boesen’s cervical spinal cord in early April.

“Typically, spinal cord injury patients undergo surgery that stabilizes the spine but generally does very little to restore motor or sensory function,” Liu explained. “With this study, we are testing a procedure that may improve neurological function, which could mean the difference between being permanently paralyzed and being able to use one’s arms and hands. Restoring that level of function could significantly improve the daily lives of patients with severe spinal injuries.”

Two weeks after surgery, Boesen began to show signs of improvement. Three months later, he’s able to feed himself, use his cellphone, write his name, operate a motorized wheelchair and hug his friends and family. Improved sensation and movement in both arms and hands also makes it easier for him to care for himself, and to envision a life lived more independently.

https://news.usc.edu/107047/experimental-stem-cell-therapy-helps-paralyzed-man-regains-use-of-arms-and-hands/

two to four weeks post injury is still very new… Here SCI’s spend the first six weeks post injury in halo in bed, then some time in halo vest.. many gain function back after this period.. so I am skeptical that the function wasn’t going to gain anyway…

Mr Arts’ injury was always treated as a ‘profound tetraplegia’ which definitionally means he has no function of any of his limbs and will not regain function, although he actually had gross motor movements of both his arms and some grip function in his hands (watch him chug a beer).. however he had absolutely no movement until well after he was out of the halo vest… so look, this is great news and all, but I remain in the cautious basket for now.

I imagine the longer the injury occurrence the less chance anything will have of treating it.

Arts said:

dv said:

 

Japan has given a stem cell therapy the “green light” for the treatment of spinal cord injuries in humans.

The country has unique regulations for the approval of regenerative medicines — therapies can be sold even if they show only hints of efficacy, on the condition that follow-up data is collected.

Therefore, four candidates will be selected for a trial, following the approval by Japan’s Health Ministry on Monday. The participants must have sustained a spinal cord injury 2-4 weeks prior, and must have lost mobility and sensory functions as a result. 

The work is being lead by a research group from Keio University. 

Significant progress has been made in the regenerative medicine/CNS space in the last 12 months:

A biodegradable nanoscaffold was developed for the transplantation of stem cells into the spinal cord and was shown to be a viable approach in animal modelsBioengineered spinal discs implanted into goats showed promiseHuman induced pluripotent stem cell-derived neurons grafted into rodents suppressed epileptic seizures

https://www.technologynetworks.com/biopharma/news/japan-approves-stem-cell-therapy-for-spinal-cord-injuries-315803

—-
Below is an article from 2 years ago, describing what I believe was the first successful trial of stem cells for paralysis caused by spinal injury.

—-

Experimental stem cell therapy helps paralyzed man regain use of arms and handsThe 21-year-old who suffered a cervical spine injury in March gains significant improvement in his motor function at Keck Hospital of USC

In March 6, just shy of his 21st birthday, Kristopher (Kris) Boesen of Bakersfield suffered a traumatic injury to his cervical spine when his car fishtailed on a wet road, hit a tree and slammed into a telephone pole.

His parents were warned there was a good chance their son would be permanently paralyzed from the neck down. However, they also learned that he could possibly qualify for a clinical study that might help.

Enter Keck Medical Center of USC, which announced that a team of doctors became the first in California to inject its patient with an experimental treatment made from stem cells as part of a multi-center clinical trial.

Charles Liu, director of the USC Neurorestoration Center, led the surgical team, working in collaboration with the Rancho Los Amigos National Rehabilitation Center and Keck Medicine of USC, that injected an experimental dose of 10 million AST-OPC1 cells directly into Boesen’s cervical spinal cord in early April.

“Typically, spinal cord injury patients undergo surgery that stabilizes the spine but generally does very little to restore motor or sensory function,” Liu explained. “With this study, we are testing a procedure that may improve neurological function, which could mean the difference between being permanently paralyzed and being able to use one’s arms and hands. Restoring that level of function could significantly improve the daily lives of patients with severe spinal injuries.”

Two weeks after surgery, Boesen began to show signs of improvement. Three months later, he’s able to feed himself, use his cellphone, write his name, operate a motorized wheelchair and hug his friends and family. Improved sensation and movement in both arms and hands also makes it easier for him to care for himself, and to envision a life lived more independently.

https://news.usc.edu/107047/experimental-stem-cell-therapy-helps-paralyzed-man-regains-use-of-arms-and-hands/

two to four weeks post injury is still very new… Here SCI’s spend the first six weeks post injury in halo in bed, then some time in halo vest.. many gain function back after this period.. so I am skeptical that the function wasn’t going to gain anyway…

Mr Arts’ injury was always treated as a ‘profound tetraplegia’ which definitionally means he has no function of any of his limbs and will not regain function, although he actually had gross motor movements of both his arms and some grip function in his hands (watch him chug a beer).. however he had absolutely no movement until well after he was out of the halo vest… so look, this is great news and all, but I remain in the cautious basket for now.

Sure sure, much more study would be needed (such as the Japanese study mentioned here).

dv said:

 

Japan has given a stem cell therapy the “green light” for the treatment of spinal cord injuries in humans.

The country has unique regulations for the approval of regenerative medicines — therapies can be sold even if they show only hints of efficacy, on the condition that follow-up data is collected.

Therefore, four candidates will be selected for a trial, following the approval by Japan’s Health Ministry on Monday. The participants must have sustained a spinal cord injury 2-4 weeks prior, and must have lost mobility and sensory functions as a result. 

The work is being lead by a research group from Keio University. 

Significant progress has been made in the regenerative medicine/CNS space in the last 12 months:

A biodegradable nanoscaffold was developed for the transplantation of stem cells into the spinal cord and was shown to be a viable approach in animal models Bioengineered spinal discs implanted into goats showed promise Human induced pluripotent stem cell-derived neurons grafted into rodents suppressed epileptic seizures

https://www.technologynetworks.com/biopharma/news/japan-approves-stem-cell-therapy-for-spinal-cord-injuries-315803

—-
Below is an article from 2 years ago, describing what I believe was the first successful trial of stem cells for paralysis caused by spinal injury.

—-

Experimental stem cell therapy helps paralyzed man regain use of arms and hands The 21-year-old who suffered a cervical spine injury in March gains significant improvement in his motor function at Keck Hospital of USC

In March 6, just shy of his 21st birthday, Kristopher (Kris) Boesen of Bakersfield suffered a traumatic injury to his cervical spine when his car fishtailed on a wet road, hit a tree and slammed into a telephone pole.

His parents were warned there was a good chance their son would be permanently paralyzed from the neck down. However, they also learned that he could possibly qualify for a clinical study that might help.

Enter Keck Medical Center of USC, which announced that a team of doctors became the first in California to inject its patient with an experimental treatment made from stem cells as part of a multi-center clinical trial.

Charles Liu, director of the USC Neurorestoration Center, led the surgical team, working in collaboration with the Rancho Los Amigos National Rehabilitation Center and Keck Medicine of USC, that injected an experimental dose of 10 million AST-OPC1 cells directly into Boesen’s cervical spinal cord in early April.

“Typically, spinal cord injury patients undergo surgery that stabilizes the spine but generally does very little to restore motor or sensory function,” Liu explained. “With this study, we are testing a procedure that may improve neurological function, which could mean the difference between being permanently paralyzed and being able to use one’s arms and hands. Restoring that level of function could significantly improve the daily lives of patients with severe spinal injuries.”

Two weeks after surgery, Boesen began to show signs of improvement. Three months later, he’s able to feed himself, use his cellphone, write his name, operate a motorized wheelchair and hug his friends and family. Improved sensation and movement in both arms and hands also makes it easier for him to care for himself, and to envision a life lived more independently.

https://news.usc.edu/107047/experimental-stem-cell-therapy-helps-paralyzed-man-regains-use-of-arms-and-hands/

A single success, haven’t these guys ever heard of statistics?

Stem cells have been used to treat spinal cord injuries in China for many more years than that. With limited success.