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What is a stroke?
A stroke occurs when the brain is temporarily deprived of oxygen due to an interruption of blood flow.
Strokes affect nearly 795,000 people in the United States alone every year and can strike at any age. Until recently, only very little could be done to prevent brain damage as a result of the stroke if not caught early and given treatment within hours of its occurrence. However, recent studies and clinical trials with stem cells conducted on real stroke victims have shown amazing results.
What causes a Stroke?
A stoke can be caused by a loss of blood supply to the brain (ischemic) or a hemorrhage (bleeding within the brain).
What is an Ischemic Stroke?
Other types of strokes, called ischemic strokes, are caused by small obstructions in the blood vessel. These can often be pieces of plaque or blood clots. Ischemic strokes account for nearly 87 percent of all strokes annually. In either case, the interruption of blood flow to the brain causes brain cells to start dying within minutes, possibly leading to lasting brain injury and neurological issues. Until now, standard treatments, such as tissue plasminogen activators (tPA), were used to dissolve the blood clot. If not administered within hours of the stroke, they are mostly ineffective at preventing lasting disability.
How does stem cell therapy work?
Stem cell therapy is a non-invasive treatment that aims to replace damaged cells within the body. Mesenchymal stem cells can be deployed systemically via IV or injected locally to target specific sites, depending on patient needs.
Stem cells may have the capacity to help stroke patients through their anti-inflammatory and immunoregulatory capabilities. Stem cell therapy is a safe treatment for stroke. Stem cell treatment may also aid in stroke recovery if administered early. (1)
Can stem cells help stroke victims?
Stem cells have a naturally regenerative and anti-inflammatory effect, seeking out damaged tissue in the body. For this reason, Stanford University School of Medicine turned to stem cells for clinical trials in healing stroke victims of different ages, anywhere from 6 months to 3 years after their stroke had occurred. The trial included 18 individuals, an average age of 61, and used stem cell transplant therapy directly to the brain.
The stem cells in the study are derived from donor bone marrow. Within months, all participants showed signs of improved motor function. The patients showed an average increase in 11.4 points on the Fugl-Meyer Assessment, a stroke-specific impairment test, and the results held for years after treatment as monitored by the university. This trial made tremendous strides in proving that stem cells could effectively treat stroke symptoms years after a patient’s stroke occurrence, and could also be effective at any age.
Stem cell therapy for stroke study
A new study conducted by Michael Levy and colleagues has found the intravenous injection of allogeneic mesenchymal stem cells to be both a safe and effective treatment option for post-stroke long term recovery.
The randomized, placebo-controlled study, published by the University of California, enrolled 36 subjects who had experienced an Ischemic stroke >6 months before the date of study enrollment. The study criteria also required that patients have no substantial improvement in neurological or functional status for two months before study enrollment.
The safety portion of the study was split into two parts, each increasing the cell dosage upon completion of previous findings. The maximum dosage was 150 million mesenchymal stem cells, as per the studies part 1 results of established safety with 1.5 million cells/kg of body weight. The parent cell bank had been tested for quality control, including; cell count, viability (are the cells alive), appearance and viruses.
According to Michael Levy and colleagues:
“The primary study endpoint was safety and tolerability, evaluated in all subjects who received any portion of an infusion, and determined by the incidence/severity of adverse events, clinically significant changes on laboratory and imaging tests, vital signs, and physical plus neurological examinations. Four secondary endpoints were scored serially to derive preliminary estimates of efficacy: National Institutes of Health Stroke Scale, Barthel Index (BI), Mini-Mental Status Exam, and Geriatric Depression Scale. For each, the change from baseline was evaluated using Wilcoxon signed-rank test, with primary analysis of preliminary efficacy being change from baseline to 6 months post-infusion, and analysis including all subjects who received an infusion except for one subject who failed to return after the day ten visit for all visits (except for month nine follow-up).” (1)
Protocol for stroke patients at DVC Stem
DVC Stem uses cord tissue-derived mesenchymal stem cells ethically sourced from AATB certified, US-donated, full-term human umbilical cords. We administer over 300 million cells that are all thoroughly tested for viability before treatment. These cells are NOT a blood product; therefore, it is extremely safe and does not require HLA or phenotypic matching.
All patients undergo therapy in our VIP treatment room located within our advanced clinic. Patients are under constant supervision from both our medical director and the supporting medical team.
We typically recommend patients stay a minimum of 4 days in Grand Cayman for treatment.
Treatment at DVC Stem spans two days.
Day 1: Arrival in Grand Cayman.
Day 2: Physical assessments & supporting therapies.
Day 3: Cell transplant & activation therapies.
Day 4: Follow-up physical & departure.
Our cell therapy protocol is safe & non-invasive. Patients will be able to travel the following day.
DVC Stem is partnered with Vitro Biopharma, an award-winning medical laboratory located in Golden, Colorado, which is fully FDA registered, cGMP compliant, ISO 9001, and ISO 13485 certified. Cells are only sourced from the American Association of Tissue Bank (AATB) certified suppliers of full-term, ethically US donated human umbilical cords. The selection of these donated tissues is exceptionally regulated and strict per AATB standards.
Find out if you are a candidate for treatment here.
References:
- David C Hess, Lawrence R Wechsler, Wayne M Clark, Sean I Savitz, Gary A Ford, David Chiu, Dileep R Yavagal, Ken Uchino, David S Liebeskind, Alexander P Auchus, Souvik Sen, Cathy A Sila, Jeffrey D Vest, Robert W Mays. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomized, double-blind, placebo-controlled, phase 2 trial. The Lancet Neurology, 2017; DOI: 10.1016/S1474-4422(17)30046-7
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Note: This post is intended to provide general information about regenerative medicine, and related areas. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.
About the author
Louis A. Cona, MD
Medical Director | DVC Stem
Dr. Cona has been performing stem cell therapy for over 12 years. He is a member of the World Academy of Anti-Aging Medicine (WAAAM). He is also a recognized member of the British Medical Association, the General Medical Council (UK), the Caribbean College of Family Physicians, and the American Academy of Family Physicians. He is the Medical Director for DVC Stem a world-renowned stem cell therapy clinic located in Grand Cayman.
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