Spinal Cord Injury

07
Apr 2015
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Dr. Molly Shoichet

Dr. Molly Shoichet and the future of regenerative medicine

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A few weeks ago, the University of Toronto’s Dr. Molly Shoichet was named as one of five recipients of the L’Oreal/UNESCO Women in Science Award.…

A few weeks ago, the University of Toronto’s Dr. Molly Shoichet was named as one of five recipients of the L’Oreal/UNESCO Women in Science Award.

Dr. Shoichet, the first Canadian to claim the prize since 2009, was recognized “for the development of new materials to regenerate damaged nerve tissue and for a new method that can deliver drugs directly to the spinal cord and brain.”

Dr. Shoichet, whose work is mainly focused on drug delivery and stem cell transplantation strategies, shares her excitement about stem cells and the field of regenerative medicine in a video interview with the Centre for Commercialization of Regenerative Medicine (CCRM).

“There is so much on the horizon of regenerative medicine that is exciting,” says Dr. Shoichet. “Our lab is really focused on the central nervous system, because there is really nothing apart from rehabilitation for these traumatic diseases like stroke, spinal cord injury and even blindness.”

You can view the other installments in the Regenerative Medicine Leadership Series here.

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23
Jul 2014
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Nature Screen Capture

Hope, time and (good) practice

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An editorial in the June 11th edition of Nature does two things remarkably well: it offers hope for the future of stem cell science while explaining why it takes so long to get things right.…

An editorial in the June 11th edition of Nature does two things remarkably well: it offers hope for the future of stem cell science while explaining why it takes so long to get things right.

Headlined “Good practice” the Nature piece explains why: “… shortcuts are simply not possible, despite charlatan claims. It takes time to learn how to coax stem cells — either from human embryos or from reprogrammed adult cells known as induced pluripotent stem (iPS) cells — to develop into the right sort of replacement cell. It also takes time to work out how to get these cells to integrate into the host tissue and to function. And the steps required to work out how many replacement cells need to be delivered, and how to deliver them safely, cannot be rushed …”

The editorial urges patience as the field “inches towards clinical testing” and points to two recent developments that inspire considerable optimism.

One is the commencement of clinical trials to treat macular degeneration using retinal stem cells (covered in previous posts here).

The other is the resumption of a clinical trial to test whether embryonic stem cells can help regrow nerves damaged by spinal cord injury. The original trial was halted in 2011 when Geron, the company behind it, decided to use its limited resources elsewhere. Now Asterias Biotherapeutics, buoyed by a $14.3-million grant from the California Institute for Regenerative Medicine, is picking up where Geron left off. (Nature doesn’t mention a Canadian led spinal cord study, but you can read about it here.)

As the article points out, the eye and the spine, in terms of stem cell research, present somewhat easier paths to the clinic: both are isolated, closed systems. The brain and heart, however, are far more complicated. Developing new, stem cell-derived treatments for diseases like Alzheimer’s and Parkinson’s and for cardiovascular conditions will be far more complicated. But there is reason for hope: “Happily, clinical trials are on the horizon. Treatments for Parkinson’s disease are just a few years away from clinical testing. And some for Huntington’s disease may not be far behind.”

One of the reasons things have taken so long is the relative newness of the field: the discovery of embryonic stem cells, which triggered much of the explosion of research underway today, was just 16 years ago. Getting scientists to agree on standardized processes and protocols has taken time. The editorial points to early-days clinical trials for Parkinson’s that didn’t use standardized practices, leading to varying results that were an “uninterpretable mishmash.”

The editorial praises Parkinson’s Disease Global Force, which is bringing together research teams from Europe, the United States and Japan to define standards for cell preparation and patient selection and monitoring for future trials. The scientists will share their universally applicable results, which in turn will move the science forward toward finding treatments and cures.

In short, there will be more trials, fewer errors. And, in the not-too-distant future, new treatments.

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27
Jan 2014
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Fehlings Screen Captre

Spinal cord study: ‘This is no flash in the pan’

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Recently we blogged about a media report on a first-of-its kind North American study to test using neural stem cells to treat spinal cord injury (See Hope not hype).

Recently we blogged about a media report on a first-of-its kind North American study to test using neural stem cells to treat spinal cord injury (See Hope not hype). The small, Phase 1 clinical trial, sponsored by StemCells, Inc.  of California, is underway in Calgary — where the first patient has received his transplant — and Toronto. NewsDesk subsequently asked Dr. Michael Fehlings, head of the spinal program at Toronto Western Hospital and the lead investigator for the trial at the University of Toronto, to share his thoughts on the experimental treatment. In this edited transcript of the conversation, he describes the excitement at seeing the trial take place here in Canada, addresses ethical concerns and stresses the importance of managing patients’ expectations.  

Q: Is this the first time that this kind of thing has been done in North America?

A: Not exactly. This is the first the first trial with adult neural stem cells in spinal cord injury in North America. But Geron, which is another California-based company, got approval to use stem cells derived from embryonic stem cells and they injected four patients with traumatic spinal cord injury in the last couple of years. Then the company stopped the trial for financial reasons.

There has been a trial with neural stem cells in patients with Amyotrophic Lateral Sclerosis (ALS). That is a different company and they have completed the Phase 1 trial. So there is some precedent in the ALS field.

StemCells, Inc. has ventured into early phase human clinical trials in pediatric neurodevelopmental conditions. They did a small Phase 1 study in children with neurodevelopmental condition called neuronal ceroid lipofuscinosis and a Phase 1 clinical trial in children with a demyelinating condition called Pelizaeus-Merzbacher disease.

But this is the first trial of its kind using adult neural stem cells. We have found very convincing evidence for regeneration of the injured spinal cord injury and, particularly, we found that the neural stem cells are effective in remyelinating residual neurons in the host spinal cord.

This trial represents an important breakthrough in Canada as well, because it is the first of its kind (here). It does reflect an acceptance by Health Canada and will provide impetus for accelerating research at the pre-clinical level. Because there are many questions that will emerge out of the clinical arena that cannot be answered in a clinic. These will be addressed in pre-clinical laboratories and we will hopefully continue to move forward into the clinical pathways.

Q: I was impressed how CTV handled the report. They didn’t create the impression that people were going to jump out their wheelchairs with this.

A: I think it is a fair statement. I think that what this type of trial does is calibrate the discussion. We have moved on from the types of dramatic reports we heard with the so called “medical tourism” — dramatic claims that raise hope but are not supported by evidence. Here, the level of rigour to get a trial like this approved by Health Canada is extremely high.  I think for us it is really important and it is very exciting for the stem cell community because it shows that Canada is on the map. I think it is very noteworthy that this American company has chosen Canada as their entry to the North American platform.

Q: As you said, it is reassuring to Canadians that the work is being done here, that they don’t have to go everywhere and pay big dollars for suspect treatments.

A: Exactly. We are treating our own citizens and patients are not being charged anything. This is not being done for profit and we are making no claims, nothing but the fact that this is an exciting experimental treatment. It’s exciting, it’s hopeful, but we also have to be realistic. Ultimately, we are trying to determine what the effects of these cells are. We don’t know if the cells will work. We hope they will show an effect.

Q: These are stem cells derived from fetal tissue. Any concern about that? *

A: Anything in the arena of stem cells can potentially generate ethical questions for individuals. Whether we deal with embryonic stem cells, stem cells from fetal tissue, induced pluripotent stem cells. My response would be that the discussion is undertaken with the individuals with spinal cord issues and with their families, so they are aware what the source of the tissue is and if they have ethical concerns, their concerns are respected. On the other hand, it needs to be respected that the people have the right to have choice.

In terms of the source, I view this as a kind of the first step. Ultimately my hope would be that we could use our patient’s own cells. I would say that while I respect that there might be a minority of individuals who might express concerns, the cells come from tissue that otherwise would have been discarded. And because they are adult cells, the risk for forming a cancer or teratoma is extremely remote.

Q: Are you concerned that you might be swamped by people with traumatic spinal cord injury who want to take part? 

A: We are getting a lot of emails and a lot of requests. Most of the individuals who contact us are not candidates. It is a challenge to manage that. We anticipated that. We are trying to manage people’s expectations. We have a long-term commitment to this. This is no short term flash in the pan. It is a long-term strategy and commitment. We want to do things right, in a very responsible manner. We are trying to help people with spinal cord injury and to do the right thing.

* Editor’s Note: Stem cell research in Canada is conducted in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, the Canadian Institutes of Health Research Updated Guidelines for Human Pluripotent Stem Cell Research and the Assisted Human Reproduction Act. For a more detailed explanation, click here.

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14
Jan 2014
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CTV Fehlings Capture

Dr. Michael Fehlings of Toronto Western Hospital

Hope not hype for spinal cord injury

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CTV News is to be commended for its excellent, even-handed reporting late last week of an exciting but early-

stage clinical trial to test using stem cell injections to treat spinal cord injury.…

CTV News is to be commended for its excellent, even-handed reporting late last week of an exciting but early-

stage clinical trial to test using stem cell injections to treat spinal cord injury.

The Friday report, originating in Calgary where the first North American patient has received the treatment, goes to great lengths to temper hope with the hard reality that a cure for spinal cord injury is many years away.

Reporter Karen Owen cautions that  “everyone’s expectations have to be realistic” and features University of Calgary neurosurgeon Dr. John Hurlbert talking about potential small improvements in patients’ quality of life, such as being able to hold a fork or button a shirt.

In other words, no one is raising false hope by suggesting patients might be rising from their wheel chairs and running down hospital halls any time soon.

The CTV website’s also offers an extended interview with Dr. Michael Fehlings, head of the spinal program at Toronto Western Hospital and the lead investigator for the trial at the University of Toronto, who articulately explains why it’s important for the public to hear about this kind of study — even though it’s so early in the game.

“It represents an advance in regenerative medicine technologies from the laboratory into the clinical realm,” Dr. Fehlings says. “This is  now a situation where the science has advanced to the stage where as rigorous a regulatory authority as Health Canada now feels the science is at a level where it can be ethically and scientifically studied in man. So this is a big deal in terms of the advance of the science.”

The North American trial builds on work already done in Europe where nine patients have undergone the treatment with no apparent adverse effects and some small gains observed. In essence, the researchers inject neural stem cells into the spine where there may be some intact nerve fibres to stimulate regrowth insulating layers called myelin. The goal is to restore electrical conduction along the spinal cord to restore muscle strength and sensation.

This is good news. It gives hope to the more than 85,000 Canadians who live with spinal cord injury. But it doesn’t set them up for disappointment by giving them hype.

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