Jun 3, 2019
Nicole Fisher
https://www.forbes.com/sites/nicolefisher/2019/06/03/arestemcellsthefutureofstroketreatment/#4ff450532eb2
In 2016, a 45-year-old road construction crew manager and former athlete named Sharon Thomas suffered an ischemic stroke so debilitating that her husband was told to seek long-term care for her in a nursing home. Sharon was unable to move or communicate. Her husband, John, was informed she would never talk, walk or care for herself again.
But as Sharon remained in the ICU in Portland, Oregon, one of her doctors told John about a clinical trial for MultiStem – a stem cell therapy from Athersys. Together, they agreed to enroll her in the clinical trial. Because it was in Phase 2, there was a chance Sharon would be given a placebo in lieu of the therapy, but it was a risk the family was willing to take. However, very shortly after IV treatments began, it was clear she was receiving a treatment that radically improved her condition. By addressing inflammation and other mechanisms in her body, her brain began to heal.
While stem cell research, medical practices and “treatments” have made headlines for years, the truth is that historically the stem cell world closely resembled the Wild West. Unsanctioned clinics and those who have tried to operate outside the purview of the FDA have led to “snake oil” sales pitches and exaggerated claims. Unfortunately, in the past there has been limited evidence that they actually work, making false claims easier than they should be.
But in recent years the regulatory environment has strengthened and improved. Giving way for more products with a stronger likelihood of success the opportunity to move forward. And what this means for patients like Sharon Thomas and the stem cell industry as a whole, is that MultiStem just might be the breakthrough that will change stroke treatment and outcomes – and do so with scientific rigor.
Stroke (also known as an attack on the brain, cutting off blood and oxygen) is the leading cause of disability and the fifth leading cause of death in the U.S. In fact, stroke is a leading cause of death in many countries around the world. But what makes stroke such a social burden is the ability of the event to interfere with brain activity in so many different ways – many of which lead to the need for long-term care. Unlike degeneration in the brain, a stroke is instant. There is no time to prepare or understand the progression of disease.
Further, the costs of care are significant for families. Long-term institutionalized care costs $100K per year on average. And that doesn’t include treatments. Worst of all for families, because Medicare only covers short amounts of time and rehabilitation services, many are forced into bankruptcy following a stroke. When it’s estimated that only 10% of stroke patients completely recover, the personal costs can mount quickly.
But this is where MultiStem also provides hope to many. Athersys has entered Phase 3 of a multi-site clinical trial to see if MultiStem could extend the treatment window for stroke from three hours – the current standard with clot-buster tPA (tissue plasminogen activator) – to 36 hours. What this means is that the tiny window for stroke treatment could be extended from mere hours to entire days. It is also simple to prepare and administer, a true “off the shelf” approach.
According to Dr. Gil Van Bokkelen, CEO of Athersys, “Our stroke program represents our most advanced clinical trial, in Phase 3, with Fast Track and other important regulatory designations, and is a key area of strategic focus for us. There is substantial unmet need in stroke treatment, and based on our prior results we think there's the potential for our technology to have a major impact on improving stroke patient recovery and quality of life, which would be a major accomplishment.”
Athersys is currently conducting a 300 patient Phase 3 clinical trial that has received Fast Track designation and will include over 50 leading stroke centers across the U.S. and Europe. That will assure the FDA that this potential best proven treatment has the statistical power to support the Phase 2 results. Dr. David Chiu, medical director at Houston Methodist Eddy Scurlock Stroke Center is a lead investigator for the MultiStem studies, and was the PI for phase 2. With more than 50 stroke trials in his 20+ year career, Dr. Chiu claims that, “This rigorous, multi-center randomized clinical trial is essential because the current standard of care is grossly inadequate.” According to him, “Stroke is the most important of the neurological diseases because of the damage it does – to patients, families, productivity and sheer costs”
But the U.S. isn’t the only trial taking place for MultiStem. In tandem with the domestic Phase 3 work is a parallel study in Japan. “Our study is progressing, and throughout the course of the year, we will be focused on bringing on additional sites and driving enrollment,” says Van Bokkelen. And that includes a notable collaboration with Healios, a partner of Athersys since 2016. They too believe that infusion of stem cells will become the standard of care for stroke patient treatment. They plan to complete their trial in Japan and potentially extend their research to China, in addition to increasing U.S. MultiStem trials. If successful, both Athersys and the growing number of stroke survivors like Sharon Thomas could soon have the Wild West of stem cells partially tamed.
Nicole Fisher
https://www.forbes.com/sites/nicolefisher/2019/06/03/arestemcellsthefutureofstroketreatment/#4ff450532eb2
In 2016, a 45-year-old road construction crew manager and former athlete named Sharon Thomas suffered an ischemic stroke so debilitating that her husband was told to seek long-term care for her in a nursing home. Sharon was unable to move or communicate. Her husband, John, was informed she would never talk, walk or care for herself again.
But as Sharon remained in the ICU in Portland, Oregon, one of her doctors told John about a clinical trial for MultiStem – a stem cell therapy from Athersys. Together, they agreed to enroll her in the clinical trial. Because it was in Phase 2, there was a chance Sharon would be given a placebo in lieu of the therapy, but it was a risk the family was willing to take. However, very shortly after IV treatments began, it was clear she was receiving a treatment that radically improved her condition. By addressing inflammation and other mechanisms in her body, her brain began to heal.
While stem cell research, medical practices and “treatments” have made headlines for years, the truth is that historically the stem cell world closely resembled the Wild West. Unsanctioned clinics and those who have tried to operate outside the purview of the FDA have led to “snake oil” sales pitches and exaggerated claims. Unfortunately, in the past there has been limited evidence that they actually work, making false claims easier than they should be.
But in recent years the regulatory environment has strengthened and improved. Giving way for more products with a stronger likelihood of success the opportunity to move forward. And what this means for patients like Sharon Thomas and the stem cell industry as a whole, is that MultiStem just might be the breakthrough that will change stroke treatment and outcomes – and do so with scientific rigor.
Stroke (also known as an attack on the brain, cutting off blood and oxygen) is the leading cause of disability and the fifth leading cause of death in the U.S. In fact, stroke is a leading cause of death in many countries around the world. But what makes stroke such a social burden is the ability of the event to interfere with brain activity in so many different ways – many of which lead to the need for long-term care. Unlike degeneration in the brain, a stroke is instant. There is no time to prepare or understand the progression of disease.
Further, the costs of care are significant for families. Long-term institutionalized care costs $100K per year on average. And that doesn’t include treatments. Worst of all for families, because Medicare only covers short amounts of time and rehabilitation services, many are forced into bankruptcy following a stroke. When it’s estimated that only 10% of stroke patients completely recover, the personal costs can mount quickly.
But this is where MultiStem also provides hope to many. Athersys has entered Phase 3 of a multi-site clinical trial to see if MultiStem could extend the treatment window for stroke from three hours – the current standard with clot-buster tPA (tissue plasminogen activator) – to 36 hours. What this means is that the tiny window for stroke treatment could be extended from mere hours to entire days. It is also simple to prepare and administer, a true “off the shelf” approach.
According to Dr. Gil Van Bokkelen, CEO of Athersys, “Our stroke program represents our most advanced clinical trial, in Phase 3, with Fast Track and other important regulatory designations, and is a key area of strategic focus for us. There is substantial unmet need in stroke treatment, and based on our prior results we think there's the potential for our technology to have a major impact on improving stroke patient recovery and quality of life, which would be a major accomplishment.”
Athersys is currently conducting a 300 patient Phase 3 clinical trial that has received Fast Track designation and will include over 50 leading stroke centers across the U.S. and Europe. That will assure the FDA that this potential best proven treatment has the statistical power to support the Phase 2 results. Dr. David Chiu, medical director at Houston Methodist Eddy Scurlock Stroke Center is a lead investigator for the MultiStem studies, and was the PI for phase 2. With more than 50 stroke trials in his 20+ year career, Dr. Chiu claims that, “This rigorous, multi-center randomized clinical trial is essential because the current standard of care is grossly inadequate.” According to him, “Stroke is the most important of the neurological diseases because of the damage it does – to patients, families, productivity and sheer costs”
But the U.S. isn’t the only trial taking place for MultiStem. In tandem with the domestic Phase 3 work is a parallel study in Japan. “Our study is progressing, and throughout the course of the year, we will be focused on bringing on additional sites and driving enrollment,” says Van Bokkelen. And that includes a notable collaboration with Healios, a partner of Athersys since 2016. They too believe that infusion of stem cells will become the standard of care for stroke patient treatment. They plan to complete their trial in Japan and potentially extend their research to China, in addition to increasing U.S. MultiStem trials. If successful, both Athersys and the growing number of stroke survivors like Sharon Thomas could soon have the Wild West of stem cells partially tamed.