Last week, the Governor of Virginia, Bob McDonnell, signed the state’s Cord Blood Education Bill (HB85) into law requiring the State Department of Health to publish information on its website about cord blood stem cells and parents’ options of preserving them.  The new law also requires prenatal care physicians to educate expectant parents about their options early enough in pregnancy so that they can make an informed decision about whether to privately bank their child’s newborn stem cells or donate them to a public bank.

With the passage of the Virginia law, 18 states -- representing two-thirds of the U.S. population -- now benefit from state-endorsed education on cord blood stem cells and the private and public cord blood banking options available to parents. 

The increasing number of states to enact cord blood education legislation stems from recommendations that were first issued by the Institute of Medicine (IOM) in 2004.  In a comprehensive report to Congress analyzing the issues involved with creating a national banking program, the IOM included two key recommendations highlighting the need to help all expectant parents make an informed choice about the storage or disposal of their newborn's cord blood stem cells and to provide education on all cord blood banking options prior to labor and delivery:

According to Dr. George Bronsky, OB-GYN and Maternal Fetal Medicine Specialist at Fairfax Hospital, parents have the right to informed choice:

“Because expectant parents have only one opportunity to preserve their child’s cord blood, they have the right to be educated about their options,” he said.  “There are many current therapeutic uses for these cells, and research is already underway that may soon lead to treatments using a child’s own cord blood for conditions such as juvenile diabetes and cerebral palsy. Despite the value of these cells, published data shows that three out of every four pregnant women consider themselves only ‘minimally informed’.”

CBR today announced the launch of two industry-leading innovations rolled into one: a new stem cell collection system that preserves a greater number and broader diversity of newborn stem cells -- from cord blood as well as the umbilical cord tissue itself – for potential use in a wider range of medical uses.  The new collection system includes: 1) an improved cord blood collection device that collects 30 percent more cord blood, and 2) a new supplementary option to preserve a section of umbilical cord tissue, which is a rich source of mesenchymal cells (MSCs). 

As reported in some of our previous blog posts, MSCs are a type of stem cell that are the building blocks of bone, cartilage, and connective tissue, and mediate the body’s inflammatory response to damaged or injured cells.  With more than 80 clinical trials currently underway in the U.S., researchers are becoming increasingly interested in the potential of MSCs to treat many different conditions, such as heart disease; stroke; bone disease and injury; and autoimmune diseases like type 1 diabetes and multiple sclerosis.  Researchers are also investigating the potential of MSCs to heal common joint and sports injuries.*  Because umbilical cord tissue has significantly more MSCs than the cord blood, CBR’s new collection system preserves a section of umbilical cord tissue, so that the newborn MSCs contained in the tissue can be later processed for medical application. 

In terms of cord blood, having more stem cells stored and available for treatment can result in better clinical outcomes and may facilitate multiple uses in regenerative medicine applications.  Although CBR’s 99 percent cell recovery rate is already the highest in the industry, the company’s philosophy of pursuing continuous improvement led CBR to look for ways to increase the amount of cord blood initially collected, thus leading to higher overall stem cell recovery.  CBR’s new cord blood collection device helps the physician to better visualize the collection as well as assist in dislodging a clot or tissue plug, which may lead to higher volume collections.  Increasing the collection volume of cord blood ultimately will yield more stem cells preserved for future use. 

Click here to see video animation of the diversity of stem cells in the umbilical cord blood and cord tissue.

Major news outlets recently reported research demonstrating that mesenchymal stem cells (MSCs), a specific type of stem cell with unique properties, restored transparency to the cloudy corneas of laboratory mice.  The data, presented by researchers during the American Society for Cell Biology Annual Meeting in December 2009, suggests that transplantation of umbilical MSCs could be a potential treatment regimen for corneal disease – whether present at birth or acquired.  This study provides further evidence supporting the potential of umbilical MSCs for a variety of diseases.

Based on a U.S. News and World Report article about the study, those with corneal diseases may stand to benefit most if/when such a therapy were to become clinically available.  They wouldn’t need to wait for a donated cornea, which, as the article states, are in short supply, so the prospect of an alternative therapy would be helpful.

More than 80 clinical trials are already underway using MSCs, and doctors are enthusiastic about the results reported for therapies addressing several conditions, including stroke, heart attack, bone injuries and autoimmune diseases like type 1 diabetes and multiple sclerosis. In addition, because MSCs serve as the foundation of connective tissue, applications in treating common joint and sports injuries may be another potential application with widespread use.  MSCs are found in bone marrow, fat tissue, and the umbilical cord.

Read more about other studies recently reported in The Stem Cell Source showing the reparative abilities of mesenchymal stem cells (MSCs):

Can Newborn Stem Cells from the Umbilical Cord Help Tiny Lungs Breathe?

More Heartening News for Cardiac Patients: Specific Type of Stem Cell Helps Repair Heart Damage

A recent story filed by Agence France-Presse (AFP), a Paris-based news service, offered a very misleading perspective on the current state of cord blood banking as well as the legitimate medical use of cord blood stem cells. 

In essence, the reporter failed to recognize the difference between overseas “stem cell clinics” offering “unproven cures” and accredited cord blood banks in the U.S. that are facilitating FDA-approved research using a child’s own cord blood stem cells for new medical uses.

The story focused on comments made by one stem cell researcher, Dr. Irving Weissman, at the annual meeting of the American Association for the Advancement of Science (AAAS).  Dr. Weissman appropriately denounces the practices of non-accredited “stem cell clinics,” which are often based in foreign countries with poor medical regulations, that offer infusions of stem cells as definitive treatments for a wide range of conditions.  Several medical bodies and institutions have raised concerns about the inability of these clinics to substantiate their medical claims as well as the risk they pose to patient safety.

This is very different from the scientifically-valid and regulatory-approved research occurring in countries like the U.S. where pioneering physicians are studying the use of a child’s own cord blood stem cells as treatments for type 1 diabetes(1) and cerebral palsy(2).   In fact, just last week Medical College of Georgia announced a new FDA-approved clinical trial to evaluate the use of a child’s own cord blood stem cells to treat cerebral palsy.  It’s important to know that participants in these clinical trials were eligible because they had access to their own, genetically-unique cord blood stem cells because their parents made the decision to privately bank them at birth.

The protocols for these clinical trials require participants to have access to their own cord blood stem cells because they provide a guaranteed biological tissue match, do not require preparatory therapies like chemotherapy, do not pose the immune complications of donor cell infusions, and eliminate the need for anti-rejection drugs which can create complications.  In other words, using a child’s own cord blood stem cells allows researchers to explore the potential of these cells in a way that is safe for patients. 

It’s also important to note, that cord blood stem cells have been used for more than two decades to treat nearly 80 conditions, including certain cancers, blood disorders and immune diseases.  Furthermore, stem cell researchers and leading medical organizations recognize that cord blood stem cells have unique characteristics.  In fact, the American College of Obstetricians and Gynecologists states that cord blood stem cells “offers several distinct advantages” over other sources of stem cells when used in treatments for these types of conditions(3). 
 
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(1)Clincialtrials.gov. Umbilical Cord Blood Infusion to Treat Type 1 Diabetes. University of Florida. http://clinicaltrials.gov/ct2/show/NCT00305344?term=cord+blood+and+diabetes&rank=1. Accessed February 2010.
(2)Clinicaltrials.gov. Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children. Medical College of Georgia. http://www.clinicaltrials.gov/ct2/show/NCT01072370?term=cerebral+palsy+and+cord+blood&rank=1. Accessed February 2010.
(3)ACOG Committee Opinion. Umbilical Cord Blood Banking. Obstetrics and Gynecology. 2008;111(2):475-477.

In our last post, we introduced the Newborn Possibilities Program, a first-of-its-kind initiative launched in-part by CBR to ensure that children born at-risk for neurological damage and disability – conditions like cerebral palsy – are given every opportunity to participate in new medical research using their own newborn stem cells.  CBR collects the cord blood of the infants in this program at no charge.
 
Today we are pleased to introduce the Newborn Possibilities Fund which is being established to provide financial assistance to families who may have difficulty participating in this new medical research due to significant expenses, like travel costs or lost days at work.  One of the first trials being supported by the fund is the first FDA-approved clinical trial studying the use of cord blood stem cells to treat cerebral palsy. 

On February 26-27, a team of 12 employees at CBR will be running a 200-mile race from Prescott to Mesa, Arizona (called the Ragnar Relay Del Sol) to raise money for the Newborn Possibilities Fund. 

You can help with your generous support.  We’ve set up a website to accept pledges and will collect funds after the race is complete. We invite you to support this worthy cause — and ask your friends and family to participate as well.  And, CBR will match the total amount raised by the Ragnar running team dollar for dollar!

Whether you pledge $20 (a dime a mile) or $200 (a dollar a mile), every pledge will go to helping to better understand the role cord blood stem cells may play in helping children with cerebral palsy. 

Go to NewbornPossibilites.com to learn more.

CBR is launching a new program in collaboration with a select group of leading U.S. medical institutions that will enable children born at risk for brain injuries to participate in new medical research using their own cord blood stem cells. The program, called Newborn Possibilities, will ensure that the cord blood of children born at-risk for developing cerebral palsy is preserved, so that if the child is later diagnosed with the condition, he or she may be eligible to receive a new treatment (being researched under approval from the FDA) using the child’s own cord blood stem cells.

The program is being jointly launched in Tucson by CBR, Tucson Medical Center and two prominent advocacy organizations based in Tucson, Save the Cord Foundation and Watching Over Mothers and Babies Foundation (WOMB).  CBR plans to expand the program to other medical centers across the country in order to connect patients who may be at risk for neurological disabilities (and who have access to their cord blood stem cells) to FDA-approved clinical trials.

CBR will be providing cord blood banking collection and storage at no cost to the families who qualify, and the program is expected to enroll nearly 700 children in its first year. Because these children will have access to their own cord blood, they may be eligible for the first FDA-approved human clinical trial evaluating the safety and efficacy of using a child’s own newborn blood stem cells to treat cerebral palsy.

A recent report by the March of Dimes estimates that 1 out of every 10 pregnancies in the U.S. results in a premature birth.  Infants who survive premature birth face a higher risk of developing neurological complications such as cerebral palsy. 

In addition, nearly 1.4 million individuals suffer a traumatic brain injury each year.  One of the highest risk groups are infants ages 0-4.  To date, there has been no cure for treating brain injuries.

Earlier today the Medical College of Georgia, the state's health sciences university, announced it will be initiating the first FDA-approved clinical trial evaluating the use of a child’s own cord blood stem cells as a medical intervention for cerebral palsy. 

CBR is the only cord blood bank participating in this study.  Investigators designed the protocol with this requirement to ensure that all cord blood stem cells included in the study have been processed and stored consistently and with the same high level of quality.

The study will include 40 children, ages 2 to 12, whose cord blood has been stored with Cord Blood Registry. Children will begin the study with a neurological exam. Then, half of the study participants will receive an infusion of their own cord blood while the other half receives a placebo. Three months later, the children will be evaluated without physicians knowing which group received the stem cell infusion. Afterward, children who didn’t get the cord blood initially will receive an infusion. Children in the study will return three and six months later for evaluation, where researchers will assess their motor skills and neurological development.

The framework for this study is supported by a body of research which has shown that cord blood stem cells have the ability to migrate to injured areas in the brain and stimulate repair.  Researchers believe that the cord blood stem cells may help initiate a healing process in the brain that may not have occurred without intervention.  Early investigational work studying children with various forms of brain injury was pioneered at Duke University.  To date, 70 children whose cord blood was stored at CBR have been treated at Duke.  (See our blog on Chloe Levine’s progress)

For more information about this study, please call the MCG Section of Pediatric Neurology at 706-721-3371.  Based on these criteria, CBR clients who believe their child may be eligible for the study should contact the CBR Transplant Center at 888-536-8517.

In a recent blog post, we discussed mesenchymal stem cells (MSCs), a particular type of stem cell with several unique characteristics that make them of particular interest to researchers who are exploring their potential in a wide variety of therapeutic applications – including preclinical research on a chronic lung disease that impacts newborns.

According to study results published in Cell Transplantation, MSCs derived from human umbilical cord blood reduced injury and inflammation in animal models of neonatal lung damage caused by bronchopulmonary dysplasia (BPD).

BPD affects babies born prematurely or those who experience respiratory problems shortly after birth who require high levels of oxygen from a ventilator for long periods of time.  Although mechanical ventilation is critical to survival, the pressure from the ventilation and excess oxygen can injure a newborn's delicate lungs over time. The lung damage of BPD can lead to long-term respiratory health problems and has few effective treatments today.

The researchers found that newborn MSCs from the umbilical cord significantly reduced structural growth impairments, cell death and signs of inflammation associated with BPD. The protective effects of MSC therapy against lung injury appeared to be a result of the anti-inflammatory activity of the stem cells.  The researchers also noted that a small number of the newborn MSCs may have developed into lung epithelial cells as well.

The study gives strong preclinical evidence to support further research for using newborn mesenchymal stem cells to treat BPD – an important step forward for some of the world’s tiniest and most vulnerable patients.

Along with asthma and cystic fibrosis, BPD is one of the most common chronic lung diseases in children. According to the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), between 5,000 and 10,000 cases of BPD occur every year in the United States.

Click here to view the study.

On the path from birth to maturity, reaching one’s 18th birthday is a very significant milestone. It’s an important achievement that validates, among many things, the training, development and experience necessary to take on life’s challenges. 

This year, CBR officially marks our 18th anniversary.  Not only were we the first family bank to store newborn stem cells for future use, but we continue to be the global leader and innovator in cord blood banking.

Our success is driven by a philosophy of continuous improvement built on a foundation of unparalleled industry experience.  And experience matters, especially in an industry like ours that represents a rapidly evolving area of science and technology. 

Today, the operations in CBR’s state-of-the-art, 80,000 square foot laboratory facility – the largest in the world – are governed by hundreds of written standard operating procedures (SOPs).  As the industry pioneer, we didn’t have a roadmap or a manual we could copy.  We wrote the book – literally.

Over time, other banks have followed us.  Some are still in business, but others are not.  Some are just beginning to learn the complexity of running their own laboratory.  The process of preserving newborn stem cells from cord blood is delicate and complex.  It takes experience to do it well, and at CBR we do it very well.  In fact, CBR’s proprietary collection and processing technologies enable us to have the highest cell recovery rate in the industry, so we are able to preserve more stem cells for medical use than any other family bank.  And, after 18 years, we’ve successfully processed the cord blood of more than 300,000 newborns. 

In this blog, we talk a lot about why newborn stem cells from the umbilical cord are unique.  It’s also important to understand what makes CBR unique.  Experience matters.

Researchers at the Fred Hutchinson Cancer Research Center in Seattle have made a significant scientific breakthrough by expanding the number of newborn stem cells from a unit of cord blood in the laboratory and then successfully using them to treat patients with leukemia.  The study, which appeared in the Jan.17th issue of Nature Medicine, is the first published report showing success using expanded cord blood stem cells in patients.

The researchers were able to achieve an average 164-fold increase of stem cells and concluded that treating patients with the expanded stem cells restored the blood and immune system more quickly that than those who received only the non-expanded stem cells.

In a Science Daily article, study author Colleen Delaney explains, "The real ground-breaking aspect of this research is that we have shown that you can manipulate stem/progenitor cells in the lab with the goal of increasing their numbers. When given to a person, these cells can rapidly give rise to white blood cells and other components of the blood system."

According to a BBC News report, scientists have been looking for ways to expand the number of cord blood stem cells in the laboratory so that there are enough cells from a single cord to meet the needs of an adult patient.
 
Click here to read the Fred Hutchinson Cancer Center press release

Imagine if stem cell therapy could be widely used not only to manage the insult caused by a heart attack, but to reverse the damage and repair the heart.  That day might not be too far off in the future according to a recent human clinical study of 53 heart attack patients published in the Journal of the American College of Cardiology.
 
In the study, researchers used mesenchymal stem cells (MSC), a particular type of stem cell with several unique characteristics which make them of particular interest to investigators.  In a CNN story about the study Jeffrey Karp, a researcher at Brigham and Women's Hospital in Boston, Massachusetts and head of a stem cell lab at Harvard University, explains that MSCs have a “natural homing ability,” and the site of injury acts as a “homing beacon” for them.  Not all stem cells have the same characteristics or capabilities. MSCs have an excellent ability to proliferate, or increase rapidly, and give rise to many types of specialized cells that are the building blocks of connective tissue, bone, cartilage, and the circulatory and lymphatic systems. 

More than 70 clinical trials are already underway using MSCs, and doctors are enthusiastic about the results reported for therapies addressing several conditions, including stroke, heart attack, bone injuries and autoimmune diseases like type 1 diabetes and multiple sclerosis. In addition, because MSCs serve as the foundation of connective tissue, applications in treating common joint and sports injuries may be another potential application with widespread use. MSCs are found in bone marrow, fat tissue, and the umbilical cord.

According to Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami's Miller School of Medicine and lead author of the Journal of the American College of Cardiology study, the future looks bright for cardiac patients:

“Mesenchymal stem cells are poised to really be the next major success in cell therapy…” he said.

Click here to read about another study recently reported in the Stem Cell Source showing the reparative ability of stem cells in cardiac disorders.

The newly released book, YOU: Having a Baby, is the latest of the popular “YOU” series of books which focus on the science of the body in a clear, compelling, and easy-to-understand manner (YOU: On a Diet, YOU: Staying Young, etc.).  Here’s what Dr. Oz and Dr. Roizen have to say about cord blood: 

Save the Blood

Well before delivery, you’ll be asked whether you would like to bank some of your baby’s cord blood for stem cells. If you are not asked, ask your doc yourself. We recommend that you save the blood. That’s because cord blood can be used to help treat nearly fifty different conditions. In fact, there’s a 1-in-2,700 chance that your child will need that blood by age twenty-one and an even greater chance that somebody in the family will be able to use it. You’ll need to prepare ahead of time if this is something you want done during the delivery. Private cord blood banking costs up to $2,000 to process the specimen, then about $100 a year for maintenance. The public option is free, but as with a regular blood bank, your specimen can be used to help someone else; if your child needs the specimen, you cannot get your sample back.

To learn more about the new pregnancy book, please visit Dr. Oz’s website

Based on data recently published in Cell Transplantation, researchers demonstrated that in a study with sheep, self-donated – also called autologous – cord blood stem cells played an important role in heart repair following surgery.

Human patients undergoing surgical repair for a common congenital heart disease called tetrology of fallot (TOF) often experience blood leakage into the right ventricle of the heart.  This leakage can cause the ventricle to malfunction, resulting in complications that could potentially lead to death.  In this controlled study, 20 sheep underwent heart surgery to simulate the post-surgical condition following repair of TOF.  The researchers of the study wanted to determine if injecting a sheep’s own stem cells from umbilical cord blood was safe and could help protect the right ventricle of the heart from this common side effect of congenital heart surgery. 

Three months following the surgery, ten of the sheep received an injection of their own umbilical cord blood into the right ventricle of the heart, and ten received a placebo injection.  Ninety days following treatment, when physical exertion was simulated in a stress test the speed of contraction and relaxation of the right ventricle was significantly higher (an indication of improved function) in those that received the stem cells compared to those that received the placebo.  In addition, the treated animals showed substantially higher capillary density than the untreated group, leading the researchers to conclude that the cord blood stem cell treatment is safe and may positively influence the function of the heart.

These study results contribute to the growing body of research suggesting that using a child’s own cord blood stem cells may play a therapeutic role in cardiovascular repair, particularly in congenital heart defects.

Click here to view the study

Brandyn Orr was only two years old when he was first diagnosed with leukemia. Determined to do whatever it took to save his life, Brandyn’s family embarked on what would turn out to be an agonizing, three-year course of chemotherapy. Brandyn’s leukemia eventually went into remission, but just six months after completing chemotherapy, he relapsed. At age 6, Brandyn needed a cord blood stem cell transplant as soon as possible in order to survive.  

Fast forward 10 years, and today Brandyn is a healthy 16-year-old, thanks in large part to a transplant of his younger brother Devyn’s cord blood stem cells.  While doctors are exploring new uses of a child’s own stem cells to treat conditions such as traumatic brain injury, cord blood stem cells have already been used for more than 20 years to treat a number of conditions, including leukemia. In fact, one of the first uses of stem cells in medicine was to regenerate healthy blood and immune cells in cancer patients after they received chemotherapy. To date, several medical therapies using cord blood stem cells within the family have benefited nearly all biological siblings of the newborn, like Brandyn and Devyn.

Knowing that cord blood may be able to help Brandyn, his mother Susan had banked Devyn’s cord blood when he was born. Brandyn received his cord blood transplant 10 years ago this month and has been cancer-free ever since.

Susan and Brandyn recently told their story on Phoenix, Arizona’s Channel 3 News.  “I highly recommend saving cord blood,” Brandyn says. “Just like it saved my life, it could save your child’s life.”

CBR recently processed and stored the newborn stem cells from the cord blood of its 300,000th client.  This is a milestone that’s important not just because of its sheer size, but, more importantly, because of what it means for CBR’s leadership role in advancing regenerative medicine.

A population of 300,000 people is equivalent to a mid-sized U.S. city like New Orleans, Pittsburgh or Tampa.   What happens to the children in cities of this size can also happen to the children whose parents made the decision to entrust the preservation of their child’s newborn stem cells with CBR.

Based on U.S. government data on the incidence of disease, this means that of the children who have newborn stem cells safely stored at CBR, by the age of six:

• 1,832 may suffer a traumatic brain injury;
• 925 may suffer from cerebral palsy;
• 718 may have suffered acquired hearing loss; and
• 189 may suffer a stroke – either before birth or after.

These are all neurological conditions that have no cure today.  However, a growing body of research suggests that the newborn stem cells from a child’s own cord blood may play a role in changing the course of these conditions by helping the body to regenerate damaged tissue and restore lost function.

To help advance this research, CBR’s Center for Regenerative Medicine is playing the critical role of matching the researchers who are focused on evaluating the use of cord blood in the treatment of these conditions . . . with the children who have these conditions . . . AND who have access to their own newborn stem cells.

As CBR assists more researchers in initiating human clinical trials, individuals who have access to their own newborn stem cells may be among the first to benefit from these emerging new therapies. 

However, in order for researchers to be able to know what’s possible with newborn stem cells, they must be saved.  We salute the parents and families of the 300,000+ children whose cells are stored with us for their foresight and confidence in the potential of regenerative medicine.  We, too, look to the future with great optimism and are committed to leading the advancement of regenerative stem cell medicine.