What is Ischemic Stroke?

Ischemic stroke is the most common type of strokes, accounting for about 87% of all strokes. It occurs when the blood supply to part of your brain is interrupted or reduced, depriving brain tissue of oxygen and nutrients. Within minutes, brain cells begin to die, potentially resulting in devastating changes to muscles and nerves of the body with either isolated or complex impairments.

According to the US Centers for Disease Control and Prevention (CDC), stroke is the leading cause of death in the United States, killing nearly 140,000 Americans each year. On average, one American dies from stroke every 4 minutes. The majority of those surviving a stroke will have some form of long-term functional and/or cognitive disability. Stroke costs the United States an estimated $34 billion each year including the cost of healthcare services, missed days of work, and medicines to treat stroke.

Many people with ischemic strokes are older (60 or more years old), and the risk of stroke increases with age. However, strokes can – and do – occur at any age. Many people with stroke have other problems or conditions which put them at higher risk for strokes, such as high blood pressure (hypertension), high cholesterol, heart disease, smoking, or diabetes. (1,2)

References:

1. Feigin VL, Forouzanfar MH, Krishnamurthi R et al. Global and regional burden of stroke during 1990–2010: Findings from the Global Burden of Disease Study 2010. Lancet 2014;383:245–25.

2. Benjamin EJ, Blaha MJ, Chiuve SE, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135:e229-e445.

What Parts of the Body are Affected by a Stroke?

The effects on the body depend on which part of the brain is damaged and how long the blockage remains. Strokes may affect movement, speech, or thought processes and memories.

In more advanced cases, strokes can cause paralysis in one or more parts of the body or loss of control of bodily functions. About 40% of people affected by a stroke will have permanent symptoms that may require special care.

What are the Common Symptoms of a Stroke?

Sudden severe headache, face drooping, arm weakness, numbness, double or blurred vision in one eye, confusion, trouble walking or talking and dizziness are all common signs of a stroke.

The F.A.S.T. Test:

Face: Smile – Does one side of the face droop?

Arms: Raise both arms – Does one arm drop down?

Speech: Say a short phrase – Check for slurred speech or speech difficulty.

Time: If the answer to any of these is yes, call 911 right away and write down the time when symptoms started.

What Increases Your Chances for a Stroke?

What is Cord Blood?

Cord blood is the blood that remains in the placenta and umbilical cord after birth. Umbilical cord blood has several unique capabilities, such as being able to create all types of blood cells, stimulate regenerative processes in a brain damaged by an ischemic stroke, and serve as the core building blocks for dozens of regenerative therapies that are reshaping medicine today.

Donated cord blood has been successfully used for 25 years to restore blood production in patients after chemotherapy. In the past decade, cord blood infusions have shown beneficial therapeutic effects for children diagnosed with cerebral palsy, and for children with cerebral strokes. (3) In a recent clinical trial studying cerebral strokes in adults, patients registered significant therapeutic improvements if infused in the first ten days after the stroke event. (4)

Cord blood can be collected, cryopreserved, and stored for decades. Cord blood is tested for pathogens using modern blood screening methods. The cord blood stem cells contained in CBC Health’s infusions are allogeneic. CBC Health’s parent company, Cord Blood Center Group, is a pioneer in cord blood banking. It has more than 20 years of cord blood experience and has successfully processed and stored stem cells for over 160,000 children for later use.

References:

  1. Feng M, Lu A, Gao H, Qian C, Zhang J, Lin T, Zhao Y. Safety of Allogeneic Umbilical Cord Blood Stem Cells Therapy in Patients with Severe Cerebral Palsy: A Retrospective Study. Stem Cells Int. 2015;2015:325652.
  2. Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, Shpall E, Wilson JM, Troy J, Kurtzberg J. Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase 1 Safety Study. Stem Cells Transl Med. 2018 May 12.

Why Use Umbilical Based Cord Blood For The Treatment of Ischemic Stroke?

The only currently available FDA–approved drug for acute ischemic stroke is intravenous tissue plasminogen activator (tPA). While tPA has markedly improved stroke care, it must be administered within a narrow time frame of no more than 4.5 hours, limiting its clinical utility. Less than 10% of stroke patients can benefit from such treatments due, in large part, to late referral to the hospital and an inability to meet other eligibility criteria including bleeding risk. (5,6)

Consequently, most of the patients are left with physical therapy and antiplatelet drugs such as aspirin in parallel with long-term nursing. All in all, the burden of stroke is felt by patients and their families across the globe.

Thus, while acute therapy exists, there is a distinct need for improved stroke recovery therapy. Numerous clinical trials conducted during the past two decades have tested a variety of pharmacological interventions to reduce tissue injury and improve functional outcomes following acute stroke, but their outcomes have not been as promising as desired. (7-9)

In the past few years, promising research has been completed indicating the potential for therapeutic benefits from stem cell-based treatments for stroke victims. So far, more than 100 studies that have been listed by the National Institute of Health (NIH) show that there is a significant improvement in the recovery and rehabilitation processes for stroke victims. Clinical researchers suggest that stem cells can migrate to the injured area of the brain and help to repair and reduce neuronal damage – a major breakthrough in the medical treatment of stroke patients.

In comparison to other stem cell sources, umbilical based cord blood stem cells offer improved plasticity and faster growth rates, are more immunologically tolerant, and are readily available without the need for invasive procedures in compromised patients. Moreover, umbilical based cord blood also contains other therapeutic cells and proteins that support the formation of new neural connections.

In June 2014, Duke Medicine was awarded $15 million to explore the use of umbilical based cord blood to treat stroke and other brain disorders like cerebral palsy and autism. In May 2018, this group published their latest breakthrough findings in a clinical trial showing that the intravenous infusion of non‐HLA matched allogeneic, unrelated donor umbilical based cord blood administered in adults after acute ischemic stroke is safe, well‐tolerated, and feasible. Also, improvements in functional outcomes were observed in all participants by three months post-infusion. (10)

References:

  1. Allen NB, Kaltenbach L, Goldstein LB, Olson DM, Smith EE, Peterson ED, Schwamm L, Lichtman JH. Regional variation in recommended treatments for ischemic stroke and TIA: Get with the Guidelines-Stroke 2003-2010. Stroke. 2012 Jul; 43(7):1858-64.
  2. Demaerschalk BM. Alteplase treatment in acute stroke: Incorporating food and drug administration prescribing information into existing acute stroke management guide. Curr Atheroscler Rep 2016;18:53.
  3. Heather Pagram, Andrew Bivard, Lisa F Lincz, Christopher Levi. Immunity and stroke, the hurdles of stroke research translation. International Journal of Stroke. 2017 Feb; Volume: 12 issue: 2: 123-131.
  4. Veltkamp R, Gill D. Clinical trials of immunomodulation in ischemic stroke. Neurotherapeutics 2016;13:791–800.
  5. Kidwell CS, Liebeskind DS, Starkman S et al. Trends in acute ischemic stroke trials through the 20th century. Stroke 2001;32:1349–1359.
  6. Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, Shpall E, Wilson JM, Troy J, Kurtzberg J. Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med. 2018 Jul; 7(7): 521–529.

How Do Umbilical Based Cord Blood Stem Cells Differ From Other Sources of Stem Cells?

Worldwide, allogeneic umbilical based cord blood is being increasingly used as an alternative source of stem cells for cell based therapy for malignant and non-malignant diseases. Especially in the past few years, it has proven great potential in regenerative medicine because it possesses many advantages in contrast to other sources of human stem cells like bone marrow and adipose fat.

Umbilical based cord blood is readily available with low potential for graft-versus-host disease and tumorigenicity as well as infectious complications. Therefore, only blood type must be matched in normal blood transfusions, and no immunosuppression is required.

Moreover, umbilical based cord blood is rich in diverse types of stem cells, mainly blood-forming stem cells, also known as “hematopoietic” stem cells or (HSC), as well as mesenchymal stem cells (MSC). Cord blood cells release high amounts of regenerative proteins that signal the body to heal itself (paracrine effect).

Over the past few years, infusions of umbilical based cord blood have been intensively used around the world as therapy for infants with cerebral palsy. Published studies have shown that umbilical based cord blood stem cells benefit young children with neurologic injury and with almost no adverse effects.

In the United States, umbilical based cord blood cells have been used in clinical trials for adults with stroke, and more trials are planned for demyelinating diseases like multiple sclerosis, as well as autism and metabolic diseases like diabetes. In China, cord blood stem cells are being administered in a trial for spinal cord injury.(11-14)

References:

  1. Kurtzberg J. 2014. Presentation at ISCT meeting. https://parentsguidecordblood.org/en/faqs/how-are-cordblood-stem-cells-different-other-sources-stem-cells.Link.
  2. Reddi AS1, Kuppasani K, Ende N. Human umbilical cord blood as an emerging stem cell therapy for diabetes mellitus. Curr Stem Cell Res Ther. 2010 Dec;5(4):356-61.
  3. Sun JM, Grant GA, McLaughlin C, Allison J, Fitzgerald A, Waters-Pick B, Kurtzberg J. Repeated autologous umbilical cord blood infusions are feasible and had no acute safety issues in young babies with congenital hydrocephalus. Pediatr Res. 2015 Dec;78(6):712-6.
  4. Park SJ, et al. Tumorigenicity Evaluation of Umbilical Cord Blood-derived Mesenchymal Stem Cells. Toxicol Res. 2016 Jul;32(3):251-8.

Do Patients Need to Provide Their Own Blood?

One of the primary benefits of CBC Health’s process is that the patient doesn’t need to provide autologous (self-derived) stem cells. Instead, patients have access to cord blood sourced from one of Europe’s most reputable cord blood providers, Cord Blood Center Group.

Perhaps Joanne Kurtzberg, MD of Duke University says it best: “I predict that the use of cord blood cells, in both autologous and allogeneic settings, as cellular therapies in the emerging field of regenerative medicine…will emerge as one of the major great advances in novel therapeutics in medicine over the next decade.” (15)

Reference:

15. “A History of Cord Blood Banking and Transplantation.” Stem Cells Translational Medicine, 3/29/17.

What Type of Experience Does CBC Health Have in Regenerative Health?

For more than twenty years, our founding company, Cord Blood Center Group (CBCG) has recorded many firsts in regenerative health. In 1997, CBCG was among the first in Europe to process and prepare cord blood for regenerative transplants. CBCG was one of the first companies in Europe to collect, process and store cord blood, cord tissue and placenta tissue with over 160,000 clients. These individuals may benefit from the regenerative effect of their cord blood in the future. Eurocord-Slovakia, a CBCG company, was among the first in Europe to establish a registry and repository for storing personal cord blood and a repository for donated cord blood which can be used for regenerative treatments for the general population.

CBC Health directly benefits from CBCG’s knowledge base. CBCG is leading the way as a regenerative health company with a solid foundation of licensed laboratories and storage facilities. The company has active branches in Switzerland, Austria, Slovakia, Italy, Romania, Hungary, Czech Republic and is expanding into new markets. Eurocord-Slovakia is a member of the international bone marrow and cord blood donors database. It is connected to the EMDIS, the international exchange network, and it is an associate member of other prestigious international organizations that set quality standards for cord blood products, such as The World Marrow Donor Association (WMDA).

CBC Health will always be at the forefront of regenerative health science. Our founding partner CBCG is directly involved in pushing the envelope for regenerative health by supporting regenerative clinical research. It has managed clinical regenerative health studies in the European Union that focus on the use of a child’s own cord blood to treat cerebral palsy. View studies here.

Since 2012, CBCG has conducted or participated in research projects and clinical trials aimed to help people find therapies for diseases that have no cure today, like the treatment of cerebral palsy and ischemic stroke. CBCG has also participated in clinical studies at leading medical institutions like Duke University Hospital in the USA. CBCG is building a better future for all as it strives to be a best-in-class company for regenerative health. CBC Health plans to follow in CBCG’s footsteps, one satisfied patient at a time.

Is CBC Health’s Cord Blood Treatment for Ischemic Stroke Covered by Insurance?

So far, for most insurance plans, umbilical based cord blood treatment or stem cell treatment aren’t covered services for the treatment of stroke patients.

The future intention of CBC Health is to make umbilical based cord blood treatment accessible for all U.S. based health insurance plans.

How is CBC Health’s Cord Blood Treatment for Ischemic Stroke Administered?

From the first phone call with the person needing treatment or their family member, a purposeful and professional but also rapid evaluation process is initiated since time is a valuable element in the treatment of stroke.

CBC Health physicians will carefully review and assess all pertinent patient data including past medical history, risk factors, date and extent of ischemic stroke, present condition, medications and transportability, etc.

How Long Will it Take For Stroke Symptoms to Improve?

In most cases, it can take up to three months before symptoms improve. As with any medical procedure, there is also the risk that a patient will not experience any improvement in his or her symptoms.

Clinical trials with children have shown that therapeutic effects are not achieved in all children, and those therapeutic improvements are achieved only with a high dose of cells. CBC Health is noted for providing high-quality therapeutic components with above-average quantities of nucleated cells.

In a recent clinical trial on stroke conducted at Duke University, all patients showed improvement when treated within ten days of the cerebral event and with a high dose of cord blood cells. (16)

Reference:

16. Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, Shpall E, Wilson JM, Troy J, Kurtzberg J: Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med. 2018 Jul; 7(7): 521–529.

How Soon After an Ischemic Stroke Can a Patient Receive CBC Health’s Cord Blood Treatment?

Clinical trials indicate that the sooner cord blood treatments are administered the better. In a 2018 clinical trial at Duke University Hospital, cord blood treatments were administered within 3-10 days following an acute ischemic stroke without any adverse effects. (17)

So how long after an ischemic stroke can a cord blood infusion be effective? More research is needed, but there is the case of a girl whose brain was injured at birth. She had a stroke and presented symptoms of cerebral palsy. At the age of five, her parents requested that she be administered an autologous stem cell infusion. After three months, her cognitive and physical condition had improved dramatically. By age eleven, she had become an excellent student, pianist, equestrian, and swimmer. She displayed only minor neurological symptoms on her right side. (18)

References:

17. Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, Shpall E, Wilson JM, Troy J, Kurtzberg J: Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med. 2018 Jul; 7(7): 521–529.

18. A. Jensen and E. Hamelmann, “First Autologous Cord Blood Therapy for Pediatric Ischemic Stroke and Cerebral Palsy Caused by Cephalic Molding during Birth: Individual Treatment with Mononuclear Cells,” Case Reports in Transplantation, vol. 2016, Article ID 1717426, 9 pages, 2016.

Can An Ischemic Stroke Patient Undergo CBC Health’s Cord Blood Treatment Multiple Times?

The safety and efficacy of umbilical based cord blood infusions were studied in children diagnosed with cerebral palsy and associated neurological complications. Patients received up to 6 intravenous infusions. Multiple intravenous infusions of allogeneic cord blood may be a safe and effective intervention in most cases.

Cord blood treatments for ischemic stroke will not interfere with your current cognitive or physical rehabilitation therapies. As more treatment data becomes available, some researchers feel that cord blood treatment could become a complementary procedure. It is the only treatment that provides a structured defense against the injury mechanisms of an ischemic stroke: