What is a 5-compartment cord blood freezer bag?

Historically, cord blood was stored in a cryo-bag with only one or two chambers. Using a one chamber bag requires all of the stored product to be used at one time. A two-chamber bag typically has 80% in one section and 20% in the other section and allows for each section to be used independently or in tandem with the other section. Prior to the advent of regenerative medicine and cellular expansion, cord blood treatments typically required the entire unit to help rebuild the blood and immune system. A small portion was used for testing and the bulk of the unit was administered to the patient.

Cord blood is now being used in clinical trials to potentially regenerate or facilitate repair by stimulating the body’s self-healing’s abilities. Regenerative medicine treatments are typically targeted, localized injections using lower dosing volumes. With this shift toward lower volumes, cord blood units could soon be used multiple times, if stored appropriately.

In support of this emerging potential for utilization of stem cells in regenerative medicine, Cord for Life^® now offers the option of storing cord blood in a 5-compartment cryo-bag. Storing the cord blood unit in five smaller volumes makes it possible to use a portion of the stem cells and save the rest for future use. The 5 compartments total the same total volume (25mL) as the one- or two-chamber freezer bags, so the added flexibility does not change the ability to use the entire unit in the typical cord blood treatments of today, while increasing user options for new treatments of tomorrow.

Which cord blood storage bag is best for me?

Although we offer the option to store cord blood in a two-chamber cryo-bag, we recommend the five-chamber bag to anyone who wants to keep their options open for using cord blood in regenerative medicine applications as they become available. Cord for Life^®’s 5-chamber cryo-bag offers maximum flexibility for storing cord blood stem cells – whether you need the entire unit for one of the 80+ FDA treatments or a portion of the unit for regenerative medicine.

What are some potential future uses for cord blood?

It is estimated that up to 128 million individuals might benefit from regenerative medicine therapy, or almost 1 in 3 individuals in the US¹. Research has shown that umbilical cord blood is a trustworthy source of multipotent stem cells for regenerative medicine². The human umbilical cord is being increasingly recognized by the medical community for its potential in regenerative medicine and cellular therapies. Previously discarded as medical waste, these valuable stem cells are now at the forefront of medical research.

According to Save the Cord Foundation, landmark trials are currently underway in regenerative medicine that are investigating treatments for brain injuries, juvenile diabetes, heart disease, and corneal regeneration³.

Cord for Life^® is committed to advancing research into the potential for cord blood in regenerative medicine, beginning with clinical trials in the treatment of lower back pain arising from the Sacroiliac Joint (SIJ) using a biological therapeutic derived from umbilical cord blood. We are actively evaluating other research avenues that improve the lives of our clients and their families.

How does cord blood banking work?

Cord for Life^® collects umbilical cord blood, from which we extract and cryogenically store stem cells for potential future use.  The process is non-invasive and results in high yields of stem cells and other related cell types. Only available immediately after childbirth, these stem cells are a 100% genetic match to the baby and immunologically naïve, making them potentially suitable for other family members and unrelated recipients.  As a result, they can be stored privately for well over 25 years for a family’s exclusive use or donated to the national inventory to be used for research or transplants for someone in need.

Sources:

1. The potential of cord blood stem cells for use in regenerative medicine: Expert Opinion on Biological Therapy: Vol 7, No 9 (tandfonline.com)
2. Umbilical Cord Blood: A Trustworthy Source of Multipotent Stem Cells for Regenerative Medicine – Tang-Her Jaing, 2014 (sagepub.com)
3. The role of cord blood in regenerative medicine – Cord Blood Education for Parents, Health Professionals and Students – Save the Cord Foundation

The human umbilical cord is being increasingly recognized by the medical community for its potential in regenerative medicine and cellular therapies. Once discarded as medical waste, the umbilical cord contains valuable stem cells that are now at the forefront of medical research.  Cord blood derived Hematopoietic  Stem Cells (HSCS) are currently approved by the FDA and being used to treat over 80 diseases and cord tissue derived therapies have been approved in the European Union, Australia, and Canada. 

What are Cord Blood Cells ​?

Hematopoietic stem cells (HSCs) from cord blood are the precursors to all other types of blood cells and cellular components, with the potential to become red blood cells, white blood cells, platelets, etc. These multipotent cells are a source of treatment and renewal for many blood disorders, immune system deficiencies, cancers, and tumors.  Historically, HSCs have only been available from bone marrow and peripheral blood transplants.  Today, HSCs from baby’s umbilical cord blood are considered to be far superior both medically and financially.

What Are Cord Tissue Cells​?

Mesenchymal stem cells (MSCs) from cord tissue are also multi-potent and can become many different types of cells, including cartilage, bone, fat, skin, and connective tissue.  MSCs show promise in treating serious wounds, burns, diabetes, Autism, Alzheimer’s, heart disease, liver disease, stroke, and spinal cord injuries, to name a few. ​ MSCs are especially unique because they can regenerate, allowing for multiple treatments. ​ In addition, MSCs can give signals to other cells to start healing chronic wounds or to prevent harmful inflammation caused by autoimmune, immune-related, and neurodegenerative conditions such as Crohn’s disease, Parkinson’s disease, and ALS. These versatile properties have the potential to make MSCs help us overcome some of the most difficult-to-treat medical conditions. 

What Are Placental Tissue Cells​?

The placenta also contains mesenchymal stem cells (MSCs), but unlike cord tissue, these cells are a 100% genetic match to the mother.  This stem cell source is currently used to treat burns, surgical wounds, eye conditions, and diabetic ulcers. Placental tissue is also showing promise in clinical trials for treating cerebral palsy, prostate cancer, throat cancer, heart conditions, neurological dysfunction, and kidney failure.  

In addition to these stem cells, there are other medically valuable components in the cord blood, cord tissue, and placental tissue.  These can also be extracted and used as raw materials to manufacture products for medical treatments and cosmetic uses. 

What Are Exosomes?

The umbilical cord also contains exosomes, nanometer sized vesicles released by every cell in the body. Exosomes are thought to be a medium for cell communication and intercellular transport. They play an important role in the transmission of proteins, lipids, mRNAs, , and DNA. They play an important role in the treatment of diseases and are being studied as a targeted drug delivery system, carrying a specific drug to a specific cell or tissues².  The exosomes released by regenerative cells such as stem cells, are potent drivers of healing and repair. Umbilical cord derived exosomes have been found to activate several signaling pathways conducive in wound healing, cell growth, and collagen synthesis. Studies have also shown that these exosomes also contain growth factors associated with skin rejuvenation1.  

What is Wharton’s Jelly?

Wharton’s jelly is the mucous connective tissue within the umbilical cord. It contains an abundance of precursor MSCs that ideally suited for use in cartilage repair. They have been shown to have the desired capacity for proliferation, differentiation, and release of trophic factors to provide cell-based cartilage restoration. Although allogeneic in nature, these cells stimulate little or no host immune response and can be stored for long periods while maintaining viability.  Off-the-shelf treatment are in development to utilize these MSCs for cartilage repair in knees. 

About Cord for Life® 

Since 1993, Cord for Life^® has been the expert in cord blood collection, processing, and storage. We were the first cord blood bank to accept both private storage and publicly donated cord blood collections from anywhere in the continental United States. Our team of scientists and cord blood banking professionals are leaders in the cord blood collection community who have helped clients around the world successfully launch and grow their organization’s cord blood collections. Our team members are passionate about our mission to Save Lives. Cord for Life^® has released more units for transplant, research, and clinical trials than any other private bank and are unique in offering both private and public banking options. 

Sources 

1. https://pubmed.ncbi.nlm.nih.gov/28919421/ 

1. https://www.labclinics.com/en/what-are-exosomes-and-why-are-they-important/ 

1. https://exopharm.com/what-are-exosomes-and-why-are-exosomes-important/ 

1. https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.16-0492 

1. https://www.sciencedirect.com/science/article/pii/S2212628717303237 

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!

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.

Given the low volume of cord blood available, Cord for Life^® cannot accept donations from cord clamping delays in excess of 60 seconds.

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.

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 conditions, infections, 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 

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.

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:

• Neurological conditions: Parkinson’s disease, multiple sclerosis and spinal cord injuries.
• Immune and inflammatory diseases: Psoriatic arthritis, autoimmune disorders and graft versus host disease in transplant patients.
• To act as a substitute for blood transfusions
• Other chronic diseases: Diabetes and heart disease.

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.