SCIENTIFIC PUBLICATIONS

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05/Jun/2020

If you’re considering storing stem cells from your newborn’s cord blood, you only have one opportunity to do so – immediately after your child is born. You may be asking how to choose the right cord blood bank to entrust your valuable stem cells to for the next 20 years.  But it can be confusing, with competing cord blood banks making conflicting claims.  That’s why it pays to do your research on how to choose a cord blood bank.

As you make this important decision, we’re here to provide expert advice about things to consider.  Above all else, when choosing a cord blood bank, your top priority should be to ensure your child’s cord blood is safe and effective in the event of a transplant.  In general, this means extracting as many stem cells as possible, while removing most of the red blood cells. Getting this right is all about the process and procedures for extracting and storing your child’s stems cells.

Focus on the processing method

Since there are only a certain number of stem cells in each collection, it’s important to choose the cord blood bank with the most effective processing method. But how do you do this? Different cord blood banks use different processing methods. Deciding which method will yield the best result can make your head spin, very quickly. Many banks make claims about their stem cell yields and more than one claim to get the most stem cells. So how do you sort through the conflicting messages?

We are here to provide unbiased advice to help you understand the differences in cord blood processing methods and what really matters.  We have rounded up some important studies from impartial researchers to help sort through the claims and understand the facts. One of the main differences is the method use to separate the stem cells from the other blood components.  Most cord blood banks use either Hetastarch, next generation method known as PrepaCyte-CB.

What the experts say about processing methods

The Newcastle Centre for Cord Blood, Institute of Human Genetics, conducted a study to determine which processing method was best.  They published their findings in the International Journal of Stem Cells, concluding that our method outperformed hetastarch, a first generation technology used by many cord blood banks.

We know there is a lot to think about during your pregnancy.  If you are thinking about any product claim made about stem cells in the cord blood industry, always ask for published research in peer-reviewed journals, like the International Journal of Stem Cells, to back-up marketing claims about stem cell yields!


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21/Apr/2020

Umbilical cord blood has been shown to have many health benefits to your newborn, your family, and to future patients in need of a stem cell transplant. Therefore it’s important to understand your options for taking advantage of this once-in-a-lifetime decision of what to do with your newborn’s cord blood.

As you begin think about your birth plan, delayed cord clamping will be something on your radar screen as part of your third stage of labor.  So will cord blood banking. Both take advantage of the health benefits of cord blood. Therefore, the questions many expectant mothers ask is “Can I delay cord clamping and still bank my child’s cord blood?

The answer is…it’s complicated. Research is still being conducted on the risks and benefits of delayed cord clamping and its impact on cord blood banking. As always, it’s best to talk to your physician about what’s right for you.  Here we share some background information that may be helpful in thinking about your choices.

What is delayed cord clamping?

Delayed cord clamping is a short wait between the delivery of your newborn and the clamping of their umbilical cord. As a result, more of the residual blood in the umbilical cord transfers to your newborn.

What are the benefits?

The World Health Organization (WHO) recommends delaying cord clamping to reduce the risk of postpartum hemorrhage. There is also evidence that delaying cord clamping in healthy newborns increases the iron available for healthy brain development later in life.

Delayed cord clamping may have significant benefits for premature and underweight babies.  For example, it can result in better blood pressure immediately after birth and less medication needed to maintain blood pressure. With delayed cord clamping, premature babies need fewer blood transfusions and are at a lower risk for serious health conditions, such as bleeding into the brain and necrotizing enterocolitis, a critical bowel injury.

Are there any risks?

With delayed cord clamping, there is a small increase in the incidence of jaundice, a potentially serious condition resulting from the breakdown of extra blood cells. Another concern is that delayed clamping could result in an excess of red blood cells, which might slow circulation.

In addition, the World Health Organization does not endorse delaying cord clamping for newborns and premature infants who require assistance with breathing using positive-pressure ventilation.

How long to delay cord clamping?

For healthy newborns, the American College of Obstetricians and Gynecologists recommends a delay of at least 30–60 seconds after birth.  The World Health Organization recommends a delay in cord clamping of at least one minute.  These times could be significantly longer for preterm infants with low to very low birth weight. Depending on the circumstances, recommended delays can be as much as five minutes.

Can I store my child’s cord blood if I delay cord clamping?

There is definitely a trade-off between delaying cord clamping and storing your child’s cord blood.  Here’s why.  As more cord blood transfers to your newborn during childbirth, less is available to store or donate for future use.

Successful cord blood collections rely on having enough blood volume to extract an adequate number of stem cells (known as total nucleated cells or TNCs) for a successful future transfusion.  In fact, studies indicate that a delay in cord clamping of 30 to 60 seconds has a small negative impact on collection of high-TNC-count cord blood units.  Importantly, delaying cord clamping beyond 60 seconds drastically reduces the chances of obtaining clinically useful cord blood units.

For a cord blood unit to have an effective potential use as a transplant product, the collected number of nucleated cells must be very high, typically over 1 billion cells.  The higher the collection volume of cord blood, the more cells are available for banking for future use.  The longer the delay before clamping the cord, the less cord blood volume available for collection (and therefore banking).  Importantly, once you decide to delay cord clamping, you should also consider how to maximize the cord blood collection volume.  With proper training and planning, a short delay in clamping can yield an adequate collection volume with sufficient cells for banking.

Should you wish to delay cord clamping, Cord for Life® is available to discuss your best options for private banking and public donation.  Our goal is to support the best outcomes for your family and other in need of a cord blood transplant.


Sources

  1. NIH Impact of delayed umbilical cord clamping on public cord blood donations: can we help future patients and benefit infant donors?
  2. NIH: Science Update: Delayed Cord clamping may benefit infant brain development, NIH-funded study finds.
  3. NCBI: Delayed Cord Clamping in Very Preterm Infants Reduces the Incidence of Intraventricular Hemorrhage and Late-Onset Sepsis: A Randomized, Controlled Trial.
  4. NCBI: Transfusion. 2018 Jun;58(6):1427-1433. doi: 10.1111/trf.14574. Epub 2018 Mar 25.
  5. American College of Obstetricians and Gynecologists. Delayed Umbilical Cord Clamping After Birth.
  6. American Pregnancy Association. Delayed Cord Clamping: The Benefits and Risks.
  7. WHO Optimal timing of cord clamping for the prevention of iron deficiency anemia in infants
  8. Guideline: Delayed umbilical cord clamping for improved maternal and infant health and nutrition outcomes. Geneva, World Health Organization; 2014.
  9. Guidelines on basic newborn resuscitation. Geneva, World Health Organization; 2012.
  10. WHO recommendations for the prevention and treatment of postpartum hemorrhage; 2012.

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06/Apr/2020

Traditionally used to treat blood disorders and help restore the immune system following chemotherapy or radiation, stem cells from umbilical cord blood are now being explored for advanced cell therapy.  According to Parent’s Guide To Cord Blood Foundation, there are now at least 60 clinical trials exploring the potential for hematopoietic stems cells (HSCs) from umbilical cord blood to treat neurological conditionsinfections, wounds, diabetes, and stroke.  These and other potential new uses for cord blood could significantly broaden their role in medicine beyond the current 80+ FDA approved treatments. 

 

FDA Oversight

During these exciting times in the evolution of advanced cell therapy, the FDA is taking a leadership role.  They are working diligently to ensure the safety, purity, and potency of these complex new biological products. In the case of stem cells derived from umbilical cord blood, the FDA classifies certain uses as drugs.  This classification applies to treatments of non-related individuals where stem cells perform different basic function(s) in the recipient than in the donor.  The FDA regulates all drugs under strict manufacturing standards for the pharmaceutical industry, known as current good manufacturing practices (cGMP).  These standards apply to advanced cell therapy that are regulated as drugs.

 

Biological products are more complex than traditional drug products made from chemical substances.  The active component(s) in a biological product are more difficult to define than the chemical ingredients in a traditional drug.  As a result, biological products are often defined by their manufacturing processes. As a result, the FDA monitors production from the early stages to ensure the final product turns out as expected. The FDA requires manufactures to thoroughly test, validate, and research any proposed changes to the manufacturing process, equipment, or facilities that could result in changes to the biological product itself. 

 

Transitioning to New Manufacturing Standards

As companies like Cord for Life® prepare to support the commercialization of new advanced cell therapies derived from umbilical cord blood, we are transitioning to these FDA standards. The FDA thoroughly inspects facilities like Cord for Life® to ensure we are strictly following the cGMP requirements.  Should there be any shortcomings in the manufacturing process, the FDA issues a Warning Letter advising the company to make necessary improvements to ensure full compliance.  The FDA gives companies the opportunity to take corrective actions to fully address any deficiencies in the FDA Warning Letter.  This oversight through facility inspections and FDA Warning Letters is critical to the safety and health of patients.   

 

Preparing for the Future of Medicine

Companies can apply for an an Investigational New Drug (IND) or Biological License once they meet the FDA’s cGMP standards.  Companies can ship product across state lines to support important clinical trials and approved therapies once the FDA grants approval.  Cord for Life® is committed to helping advance medicine through stem cell therapy and has worked hard on complying with the standards to ensure the safety, efficacy, and purity required.  As we transition from the FDA standards for cord blood processing to their standards for drug manufacturing, we rely on their guidance and support.

 

References: 

  1. Recruiting Clinical Trials of Cord Blood or Umbilical Cord Tissue, Parent’s Guide to Cord Blood Foundation. 
  1. Frequently Asked Questions About Therapeutic Biological Products, FDA 

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02/Apr/2020

Birth Planning 101

When you are expecting a baby, there is a lot to do!  From staying healthy during your pregnancy to preparing to take your newborn home.  Of course, there is also the delivery itself, which is where your birth plan comes in.  A birth plan is the best way to plan and organize your labor and delivery.  It will help you be fully prepared for the decisions you will need to make during this exciting time.  Your birth plan is a checklist of preferences for personal comfort, medical procedures, and bonding with your baby. It guides the conversation with your OB-GYN, midwife, doula and hospital so they understand your ideal birth experience.

Keep in mind that a birth plan is just that – a plan.  Since you cannot predict everything with certainty once labor begins, you or your doctors may need to make changes to the plan along the way. For example, the COVID19 pandemic has changed the delivery game plan for many expectant mothers when it comes to people that can be present for labor and delivery.  This added stress makes it even more important to discuss some important medical decisions with your partner and physician prior to giving birth.

Packing Your Hospital Go-Bag

Your birth plan is a great first step in deciding what to pack in your hospital go-bag.  It’s a good idea to think about the things you would like to bring with you to relax and enjoy the experience and start setting them aside.  This way, when the moment arrives you won’t be scrambling for all the things you would like to have with you during labor and delivery.  Since the hospital or birthing center may not have everything you need, it’s good to start thinking about the things to pack in your hospital bag.  Some things to consider are what you would like to wear, music or photos you would like to bring, and any birthing assistance you may want.

It’s also a good time to think about what you plan to do with your child’s cord blood, which contains potentially lifesaving stem cells.  You have three options to consider – donate, privately bank, or discard your child’s cord blood.  It’s important to know your options so you can be prepared with a free collection kit should you choose to save your child’s stem cells for future use.

Recruiting Your Support Team

In planning for the delivery of your child, it’s important for the medical team to understand who you would like in the room to be sure they can accommodate your loved ones.  Some hospitals limit the number of people to two or three, so you may have to prioritize. You’ll also want to be sure you have the right people on speed dial when it is time to head to the hospital or birthing center. Unforeseen events can change this plan, but it is important to have a starting point so your loved ones know what to expect.

Planning Your Labor

With labor comes pain and discomfort, so researching relaxation techniques and pain management options in advance will make your decisions easier when the times comes.  Options for pain medications vary in terms of how quickly they work, whether they enter your baby’s bloodstream, and how they affect your ability to push.  You also have several natural techniques that may require some practice to get them right such as acupuncture, acupressure, and breathing exercises.

Delivery Room Decisions

After you deliver your child, you’ll also need to deliver your placenta. You have the option of delivering it naturally or with assistance. Your doctor or midwife may suggest a shot of pitocin to facilitate delivering the placenta and to minimize hemorrhaging after the baby is born. They can also use controlled traction, pulling on the umbilical cord while contracting the uterus. It is a good idea to discuss your options with your OB-GYN or midwife to understand your options.

Delivering Your Placenta

Though not nearly as exciting as your newborn, your placenta is a pretty spectacular thing. Weighing in at about one-fifth the size of your newborn, your placenta provided nourishment and oxygen to your growing child for 40 weeks.  Once routinely disposed of by hospitals, these days a growing number of women are consuming their placentas believing it has health benefits, such as boosting energy levels, stabilizing postpartum hormonal ups and downs, and helping with milk production.  You have the choice of taking your placenta home for spiritual or health reasons, encapsulating your placenta, or discarding it.

What To Do With The Umbilical Cord

There are also decisions to make about your child’s umbilical cord!  For nine months, your placenta has been delivering everything your child needs through that incredible cord, packed full of stem cells, red and white blood cells, even disease-fighting T-cells. It is important to take time to think about what to do with the blood that is left in your child’s umbilical cord to be sure it is put to the best use.  You have the option of delaying cord clamping to push more of those stem cells into your newborn and the option of saving their stem cells for future use through cord blood banking.  In preparing your birth plan for these important decisions it’s best to review your options with your OB-GYN or midwife.

Bonding with Your Baby

Labor and delivery are both exhilarating and exhausting. Once your newborn arrives, you’ll want to consider several firsts – the first time you hold your baby, their first bath, the first time you feed your child.  You will want to be sure to do what feels right for you, rather than relying on what others think. You will also have to consider how much time to spend with your newborn balancing bonding time with your need for rest and recovery after childbirth.

Newborn Medical Procedures

It is a good idea to be prepared for the routine medical procedures that come with childbirth, including vaccines, hearing screenings, antibiotic eye medications, immunizations, and circumcision.  These decisions may feel overwhelming, unless you have spent time to understand your options.

Digital Birth Plan

To make the process easier, Cord for Life has created a digital birth plan with all the things you will need to consider in planning for the birth of your child.  It is easier to fill out online or offline and simple to print and share with your doctor and family.


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07/Jun/2018

So much research is going on with stem cells from cord blood as scientists work to unlock the secrets of stem cells.  Much of the research centers on the anti-inflammatory properties of stem cells from umbilical cord blood.

Medical research into stem cells is ongoing, offering the potential to treat diseases or injuries that have traditionally been difficult to manage. Clinical trials exploring the potential for umbilical cord blood as a treatment include:

Some of the many intriguing studies hope to find cures for many disorders that effect children and adults include: 

Repairing Brain Functions

Progress is being made in understanding how stem cells from umbilical cord blood can improve the lives of children suffering with Cerebral Palsy and Autism.

Stem Cells and Cerebral Palsy

In fact, a recently published study by researchers at Duke University of children with spastic cerebral palsy found that an infusion of their own cord blood improved both their brain connectivity and motor function.

Stem Cells and Autism

Research into treating Autism with stem cells from cord blood has shown potential for improving socialization.  Based on these promising results, research continues to decipher the connections.

Keeping Memories Alive

Researchers are also exploring stem cells from umbilical cord blood as a cure for Alzheimer’s disease.  Exploratory studies in mice have shown that stem cells from umbilical cord blood reduce behavioral impairments associated with Alzheimer’s disease.  These initial findings have justified further exploration of how stem cells from umbilical cord blood could play a role in a cure for Alzheimer’s disease.


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07/Jun/2018

Stem cells perform three important functions:  1.  They renew themselves; 2. Differentiate into other cells; and 3. Renew other cells. Hematopoietic stem cells (HSCs) can restore the immune system following  chemotherapy or radiation for leukemia, lymphoma, and other life-threatening diseases.

Historically, HSCs have only been available from bone marrow and peripheral blood transplants.  As cord blood processing and storage technology has advanced over the last thirty years, it is now superior to both bone marrow and peripheral blood as a source of HSCs.

Stem cells from umbilical cord blood are now widely used in clinical research and are a leading source of stem cells for cellular therapy.    In addition, stem cells from umbilical cord blood are increasingly available as transplant units stored in public and private cord blood banks steadily increase every year.

Stem cells from umbilical cord blood have some important benefits that stems cells from bone marrow and peripheral blood lack.    In considering private cord blood banking for your growing family, here are some highlights on the benefits of banking your child’s cord blood:

Cord Blood Offers More Than Bone Marrow

Should your child or another family member need a stem cell transplant, you’ll want to know there is a readily available genetic match.  The National Bone Marrow Registry and public cord blood banks won’t provide the same certainty as privately banked cord blood.

  • Your child’s stem cells are a perfect genetic match to them and a potential genetic match for siblings and other family members.  Finding a matching unrelated donor is less certain, particularly for minorities or mixed-race families.
  • Cord blood is collected in advance, tested, and stored frozen, ready for use.  Bone marrow donation requires finding a match, scheduling surgery, collection under general anesthesia, and recovery.
  • A small volume of cord blood can be used in transplants.  Bone marrow transplants require a quart of more of bone marrow and blood.

Cord Blood Has a Lower Risk of Complications

In thinking about the options for a stem cell transplant, safety and efficacy are critical to a full recovery.  Cord blood stem cells are superior to bone marrow stem cells in terms of risks of rejection, contamination, and infection.  They also outperform bone marrow in their ability to replace cells damaged or deceased from chemotherapy or radiation treatments.

  • Cord blood has a lower risk of graft-vs-host disease (GVHD). Approximately 10% of patients experience complications from chronic graft-versus-host disease from cord blood transplants versus 60% for bone marrow recipients.  Graft-versus-host disease occurs when immune cells from the donor (the graft) attack the recipient’s cells (the host).
  • Cord blood transplants have a low risk of tumor growth, low risk of viral contamination, and high cell proliferation capacity.
  • Latent viral infection is rare in cord blood donors.  Cytomegalovirus (CMV) infection is present in <1% of U.S. cord blood donors, but >50% of U.S. adult bone marrow donors.  Cytomegalovirus (CMV) is a common virus that can infect almost anyone.  While it rarely causes problems for healthy individuals, it is a leading cause of death in bone marrow transplants as a result of their weakened immune systems.

Source:  Bioinformant Worldwide, LLC: Complete 2015 – 2016 Global Cord Blood Banking Industry Report


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07/Jun/2018

In addition to potentially life-saving stem cells, your newborn’s umbilical cord blood also contains their DNA.   Storing your child’s cord blood ensures that their baseline genetic information will be available if ever needed.

What Can Genes Tell Us?

The sum total of all the information coded into your child’s individual genes is their genome.  Simply put, it’s what makes your child unique.  Your newborn’s genome determines whether they’ll grow up to be right or left handed, have brown or blue eyes, if they’ll need glasses, and how well they’ll sleep at night.

The information locked away in your newborn’s genome can be decoded to help anticipate potentially serious health risks, both now and as they grow older.  Hospitals routinely conduct genetic screening tests on newborns using a heel prick test.  Using a small amount of a newborn’s blood they screen for a number of harmful or potentially fatal genetic disorders.  These tests help identify potential risks for biotinidase deficiency, congenital adrenal hyperplasia, congenital hypothyroidism, cystic fibrosis, galactosemia, maple syrup urine disease, MCAD deficiency, phenylketonuria, severe combined immunodeficiency, sickle cell disease, tyrosinemia, and toxoplasmosis.

With decades of research into mapping the human genome, researchers have also identified many of the genes associated with worries that keep parents up at night as their children grow – whether they have any allergies to foods, vaccines, medicines; questions about their physical development; and risks for inherited diseases later in life, such as Autism Spectrum Disorder, Heart Disorders, Breast & Colon Cancer, or to any other diseases.

Genetic Insights from Cord Blood

Scientists working to map the entire human genome don’t yet know all the associations between genes, childhood health, and personal development.  However, what they’ve already discovered can be an early warning system for topics to discuss with your pediatrician.

Genetic testing of your child’s cord blood can identify potential food intolerances, like peanut allergies, lactose intolerance, and egg allergies.  It also can identify potential immunities to vaccines, including measles-mumps-rubella, and smallpox; lethal reactions to medications like codeine; and difficulties metabolizing vitamins, such as D, B12, and E.  Armed with this knowledge, your pediatrician can do further testing to confirm whether there is cause for concern.

You doctor can use only a small portion of the stem cells you stored with us for genetic analysis.  They would simply contact us to request a small sample of your child’s stem cells for DNA analysis.  Our team will have it processed and shipped to them.

Banking Cord Blood Archives DNA!

Newborn DNA is unlike that of older children and adults.  In addition to the information about risks for inherited genetic diseases, it holds important baseline genetic information.

Doctors can compare this baseline genetic information later in life to find possible changes caused by environmental factors. Differences in the genome can provide insights into how food, drugs, stress, or exposure to toxins effect how genes function.  Understanding environmental versus inherited factors can help determine available treatment options.

Banking your child’s cord blood also stores a record of their baseline DNA if ever needed.


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Our purpose is to provide the expectant mothers with information necessary to discover the lifesaving potential of umbilical cord blood.

Copyright Cord for Life 2019. All rights reserved.

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