Researchers identify stem cell stroke therapy that significantly improves stroke survivor mobility. Read about the clinical trial from Stanford University.Innovative New Stem Cell Stroke Therapy

Stem cell researchers have demonstrated a number of innovative treatment prospects. Few of those prospects may be as bold as the work being conducted by the team at Stanford University Medical School. The team at Stanford has published their extraordinary results following a study that evaluated a new form of stem cell stroke therapy.

In brief, Stanford researchers conducted a clinical trial where they used genetically modified adult stem cells and injected them into the damaged region of the brain in stroke patients.

What is a Stroke?

A stroke takes place when the blood flow to some region of the brain is halted. The result of lost blood flow is the affected portion of the brain cells begins to die. According to the National Stroke Association, the catalyst for a stroke can vary slightly; however most begin as the result of ruptured blood vessel in the brain, a blood clot in the brain, or by way of transient ischemic attack (TIA) which mimics the effects of a stroke. Other factors such as a traumatic head injury have the potential to cause a stroke.

People suffering the effects of a stroke can experience a wide range of impacts. Those impacts can be as simple as reduced motor function. A more significant stroke has the ability to completely debilitate the person impacted through partial paralysis, lost speech function, and lost neural function. These impacts become much greater when you consider that approximately 800,000 people experience a stroke every year. That’s the equivalent to the population of Boston – every year!

Further, the road to recovery from a stroke is typically a long one. Physical therapy for stroke survivors will often extend years and even then does not ensure complete recovery. If a patient is going to make progress, it is typically going to take place in the first 6-months of therapy. Many of the people make progress to recover motor function; but not all. In all cases, therapy will be paired with lifestyle changes that help reduce the risk of a future stroke.

In summary, existing treatments are focused on preventing future recurrences and on regaining some level of motor capacity.

A New Approach to Treatments

Stanford University medical researchers have been evaluating a number of medical innovations when it comes to stroke treatment. The program is studying the benefits of induced hypothermia and brain recovery as well as gene therapy; however it is their stem cell transplant research that has provided remarkable results.

During their stem cell stroke clinical trial, 18 patients were selected that had suffered a stroke within the past six months to three year. All patients selected also had significant motor loss. For the procedure, patients were lightly sedated; but remained awake while a small hole was made in the skull. A needle was inserted through the hole where the team injected 2.5, 5, or 10 million adult stem cells into the affected region of stroke patients’ brains. The stem cells used were genetically engineered by a company, SanBio, to include the same trigger that begins brain development in infants. The cells survive between one and two months in the patient; but secrete growth factors while in place further enabling the healing to take place.

It is remarkable that the patients were able to leave the hospital the day following the procedure. What’s even more remarkable is what followed.

Stem Cell Stroke Treatment Results

Patients undergoing the procedure reported a measurable recovery of motor function in as little as a few weeks. Additionally, no lingering side effects have been reported. One patient in fact reported that prior to the procedure she was unable to right arm and her right leg worked but not well. Following the procedure, she described her experience as follows:

“After my surgery, they woke up.” – A patient describes her experience following the innovative stem cell stroke therapy.

Gary Steinberg, MD, PhD a professor and chair of neurosurgery at Stanford University Medical School and led the research team in this clinical trial. He cautions that patients demonstrated improvements; however a larger study is needed to build upon those observations. This treatment is not necessarily ready for mainstream implementation. It has however opened the door to conducting a larger scale clinic trail that the university has already launched.

Steinberg said of the results:

“patients improved by several standard measures, and their improvement was not only statistically significant, but clinically meaningful. Their ability to move around has recovered visibly. That’s unprecedented. At six months out from a stroke, you don’t expect to see any further recovery.”

In another example, the team observed the progress of a 71-year old woman. Her total mobility was limited to one of her thumbs prior to the procedure. That same patient has the mobility to move her arm above her head and can now walk.

Motor Function Recovery Results

Researchers used the Fugl-Meyer Assessment (FMA) to evaluate patient progress. The FMA is a tool used specific to evaluating motor function impairment in stroke victims. It measures a range of physical activity including balance, sensation, and joint function just to name a few key areas. Using the FMA allowed the researchers to make quantitative observations and measure patient progress over time.

Patients in the Stanford Stroke Stem Cell Clinical Trail experienced an average improvement of 11.4 points in the FMA score. From the standpoint of stroke treatment, this is game changing. No therapy exists that will yield meaningful results for a patient six-months after experiencing a stroke. These patients experienced significant improvement up to three years after their stroke.

Doctors were able to observe the first signs of improvement within weeks of the injections. What surprised them is that improvement was still continuing 6-12 months afterwards.

Steinberg elaborated on the team’s observations:

“Older people tend not to respond to treatment as well, but here we see 70-year-olds recovering substantially,” Steinberg said. “This could revolutionize our concept of what happens after not only stroke, but traumatic brain injury and even neurodegenerative disorders.”

Next Steps for Stem Cell Research

The parameters for a next-stage double-blind clinical trial have been defined and candidates are being evaluated for inclusion in the program. Additionally, Stanford has given indications that this work may provide a future avenue of research for Alzheimer’s disease, Parkinson’s, and Lou Gehrig’s disease.

Keep an eye open for future research updates!

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References:

Stanford Medicine Newsletter: http://med.stanford.edu/news/all-news/2016/06/stem-cells-shown-safe-beneficial-for-chronic-stroke-patients.html; Accessed 07/09/16