Resources: Frequently Asked Questions About Cord Blood Banking

Frequently Asked Questions About Cord Blood Banking

How long should we store our cord blood?

Cord Blood should be stored until it is needed! Most doctors and researchers believe that cord blood can be stored indefinitely, allowing it to be used for multiple generations. With the average age of stem cell transplants being 40 years old, the longer you store your cord blood and cord tissue, the higher the probability of use, making your stored sample more valuable over time.

Will Core23 talk with my OB/GYN about the cord blood banking process?

Absolutely! We will contact your OB/GYN to let them know of your decision, as well as send information and techniques on how to best maximize your collection. It is still in your best interest to also discuss this with your physician prior to delivery.

Can cord blood be collected if I have a C-section?

Yes, cord blood can be collected if you have a C-Section delivery. In fact, research has shown that cord blood collections for C-section patients have higher volumes and cell counts than traditional birth collections. Additionally, our collection kit contains a sterile cord blood collection bag so that it can be safely used by the physician during the C-section.

Can you still cord blood bank with delayed cord clamping?

While it is possible to still collect the cord blood sample with delayed cord clamping, typically the volume and cell counts are lower than regular collections, potentially making your cord blood unit non-therapeutic due to lack of enough stem cells to heal the body or treat a disease.

Who regulates cord blood banking facilities?

Cord blood banks are regulated by the United States Food and Drug Administration (FDA). All cord blood banks must register with the FDA and be subjected to periodic inspections as well as comply with all the regulations outlined in 21 CFR 1271 (Human Cells, Tissues, and Cellular and Tissue Based Products). Additionally many cord blood banks, including Core23 BioBank, voluntarily subject themselves to additional regulation under accrediting bodies like AABB and FACT. Core23 BioBank is in the process and working towards achieving accreditation with these organizations which can take up to 2-3 years to complete.

Why should I choose to collect and store my baby’s cord blood?

Cord Blood contains many types of potent and valuable stem cells that can be used to heal the body, treat diseases, and save lives. A stem cell is basically a cell that has not decided what it wants to become, which allows the cells to change into whatever is needed to treat the disease or injury. The umbilical cord blood has an incredibly high number of young, fresh, powerful cells that will otherwise be thrown away if not banked. Once the stem cells are discarded at birth you can never go back and save them later; it is literally a once in a lifetime opportunity.

What are my options for saving my baby’s cord blood?

There are two options to save the cord blood. First, a family can elect to donate the cord blood to a Public cord blood bank similarly to donating blood to the American Red Cross. The family is neither charged or paid for donating the cord blood and the family relinquishes all rights, current and future, to the use or application of the cord blood. Parents need to realize that as much as 80% of donated cord blood units may never be made available for transplant and that only the highest volume and highest cell counts are saved at a public bank due to the large cost of testing and processing.

Second, families can choose to save their child’s cord blood, tissue, and plasma simply by enrolling with a Private cord blood bank. The Private bank will send a collection kit for the doctor to use in saving the cord blood and, in Core23’s case, we will send a medical courier right to the labor and delivery unit at your hospital and retrieve the specimen for processing and storage at our BioBank.

Who can use my baby’s cord blood stem cells?

Cord blood can be used not only for the child who donated it but also first and second degree relatives, such as that child’s siblings, parents, or grandparents, assuming they are an HLA match. The matching process is much like matching for an organ or bone marrow transplant. For example one out of four siblings will be a perfect HLA match with a donor sibling therefore eliminating rejection complications with that cord blood unit.

How likely is it that my family will need the stem cells?

While our hope is that no family ever needs a stem cell therapy to treat a life threatening disease, the reality is that many of us will experience one or more of these conditions. Research has projected that as many as 1 in 217 people could use a cord blood cell therapy in their lifetime, and with the amazing progress researchers are making on conditions such as autism, Alzheimer’s, heart disease, and diabetes, this number could substantially change in the foreseeable future.

Does Core23 have its own laboratory?

Yes, Core23 BioBank has our very own state-of-the-art laboratory located in Springfield, Missouri, right in the middle of the United States.  We have our own class 10,000 clean room, an advanced processing center with cutting edge analysis software, as well as our own cryopreservation & storage facility onsite, allowing us to monitor and protect your sample in-house.

What makes Core23 different than other cord blood banks?

There are three main areas that make Core23 different from other private banks: how we collect the cord blood, how it is processed in our lab, and how we store the collection long-term. All of these areas are aimed at providing our families with the best opportunity for successful retrieval and therapeutic use of their stem cells.

Proper cord blood banking can’t happen without a successful collection during delivery. How we are different during the collection is through the use of our specialized Pall Sterile Cord Blood Collection bag, which allows the physician to collect cord blood from both vaginal and C-section deliveries. Also, our collection bag contains Citrate Phosphate Dextrose, a safe anticoagulant used to keep the cord blood in its proper form until it reaches our lab. This is a key difference for Core23, as many other collection bags use Heparin, a potentially dangerous compound that we feel has no place in the cord blood collection process.

Second, every cord blood bank has to process the collection, which involves separating and testing the collection for viability. Core23 utilizes a proprietary method to process the samples that does not involve using synthetic chemicals like Prepacyte and Hetastarch, both of which can induce artificial cell separation, causing a lower volume collection and reduces the number of HPC’s and MSC’s. Our goal is to keep as many stem cells as we can for our families, and we want to make sure our process doesn’t take these precious cells away for any reason.

Lastly, the long term value of cord blood is protected by the storage method of each cord blood bank. Core23 chooses to store your collection in multiple “aliquots”, or simply put, multiple containers rather than as a single (and less expensive!) container that other facilities use. Our reasoning for this is that if you were to request your sample for use to treat a loved one, once the sample is thawed, it CANNOT be re-frozen. This means that if you are at a single container storage facility, all of your cord blood will be used for that individual therapy, even if not all of the stored collection is required. Since Core23 separates your collection into individual containers, we can thaw and send to your physician only what is required for the particular therapy, allowing you to keep, and more importantly USE what you still have in the bank for another therapy.

How does Core23 ensure confidentiality of your personal information?

Each of our families is assigned a unique patient identification number that becomes their identity inside our processing and storage systems. This allows our staff to properly label collections and testing results without knowing which individual the collection came from. Furthermore, we utilize a state-of-the-art software program which provides our families with the highest security of patient information, encrypted file storage and backups, while still maintaining exceptional ease-of-use for our families during the initial setup and medical history documentation.

What is cord tissue and how can it help my family?

Cord tissue, or “Whartons Jelly” as it is sometimes called, is the long skinny part of the umbilical cord that facilitates the passage of blood and nutrients to and from the mother and baby. As with any organ or tissue, it is made up of billions of cells, one type of which is called Messencymal Stem Cells (MSC’s). While MSC’s are not currently used to treat a disease, they have been identified as having tremendous future potential in regenerative medicine, with numerous studies and trials currently underway in areas such as traumatic brain injury, stroke, breast and lung cancer, among others.

What is cord plasma and how can it help my family?

Cord plasma is part of the cord blood when it is extracted from the umbilical cord vein just after delivery of your child. The plasma is separated from the cord blood during the Core23 Biobank proprietary processing procedures in our state of the art laboratory. You should save this precious biological product because it contains cytokines, growth factors, proteins, platelets, and cell products that could be useful for future medical treatments .

Why is Core23 not accredited?

Core23 Biobank is diligently working on achieving accreditation and anticipates receiving accreditation in the near future. We currently operate our facility under the standard operating procedures and guidelines set forth by the accrediting bodies to ensure our families receive the highest level of service and protection for their collections. The process of attaining accreditation can take several years and requires hundreds of cord blood units to be banked in the facility. As we work towards these goals, rest assured that your collections are safe and secure.

What tests does Core23 perform on each cord blood sample?

Core23 Biobank performs many tests on the cord blood and maternal blood specimens. First, the cord blood is tested for a complete blood count, which involves testing the number and types of cells, sterility testing for bacterial and fungal contamination, and flow Cytometry that shows the viability and number of stem cells. Core23 Biobank also does pre and post processing samples for additional testing when the specimen is requested for transplant, which usually includes post thaw cell viability analysis and stem cell enumeration as well as HLA typing and confirmatory HLA typing. No samples will be released for transplant without a thorough screening process that includes these tests at a minimum.

The maternal blood samples go through a rigorous and thorough infectious disease testing from the American Red Cross National Testing Laboratory for donor screening of blood products. The reason we use the maternal blood and not the cord blood is because there is no FDA approved methodology of testing cord blood for all of the different infectious diseases and the limited volumes of cord blood make it impractical to sacrifice those precious stem cells to testing that can otherwise be completed with maternal samples.

What happens if my cord blood has a problem and cannot be stored?

If a cord blood unit does not meet our laboratory standards for automatic processing and storage, a Laboratory Manager from Core23 Biobank will contact your family to discuss the cord blood analysis data. A low volume collection or potential problem does not necessarily mean that the sample cannot be used in the future, but we want to ensure you understand the limitations of the sample prior to your decision. Ultimately, families get the final say as to if they want to save the cord blood, tissue, and plasma. A family that chooses not to store the cord blood due to falling outside of the laboratory standards will be refunded a pro-rated portion of the cord blood banking costs minus expenses already incurred by Core23 Biobank such as collection, transportation, testing, and pre-processing fees.

Who owns my baby’s stored cord blood cells?

Your family always maintains ownership of your cord blood, tissue, and plasma. Core23 Biobank’s role is to facilitate the collection, testing, processing, and storage of those precious stem cells and to keep them safe and protected in our long term storage facility, ensuring that they are always available for your family should the need arise.

Is the first year of storage included in the processing fee?

Yes, the first year of storage is included in the initial fee for cord blood, tissue, and plasma banking. For each subsequent year, your family has the option of paying the storage fee annually or you can take advantage of special discounting for prepaying your storage fees. See our pricing page for more information.

Is there a charge to release the cord blood from storage if needed?

There is no charge to release your cord blood, tissue, or plasma unit from our long-term storage. Prior to release, any collection that is to be used for clinical transplant must go through post-thaw testing and analysis, which will be required by the FDA and the directing transplant physician. Costs for testing, transportation, or subsequent analysis are typically paid or reimbursed by your insurance company, but we recommend contacting your insurance provider to discuss their coverage.

What is the Core23 Gift Registry?

The Core23 Gift Registry is a program designed to help expecting parents leverage the goodwill of their friends and family by creating a way to financially contribute to the cord blood, tissue, and plasma banking services. Making a contribution is as easy as picking up the phone and connecting with Core23 BioBank to make a contribution or using the online platform GoFundMe.com to create a campaign, promote it to your friends and family, and lower the cost of cord blood banking services for the expecting parents.

What is the process for cord blood to get from our delivery room back to Core23?

After the cord blood is collected, either the doctor, nurse, or family member will contact Core23 BioBank and let us know the specimen is ready for pickup. Core23 will send a medical courier right to the labor and delivery unit to retrieve the cord blood collection and bring it straight to our laboratory. We want this process to be as easy as possible for our families, while also not placing additional burden on you to deliver or mail the collection kit back to us. We use only professional, licensed medical couriers to provide the faster possible delivery of your collection to our lab.

Why does Core23 use a medical courier instead of having patients ship the collection back?

We chose to use professional, licensed medical courier services to retrieve and transport the precious cord blood stem cells in order to get it to our lab in the fastest manner possible without the risks of other mail-back or transportation option. Every second matters with these precious stem cells, and the sooner it gets to our lab, the higher volume of your collection we can preserve.

How soon after delivery does Core23 need to receive the cord blood collection to remain viable?

The sooner the better! Every second that the cord blood unit is not in our storage facility, you are losing precious stem cells that could be used to save a life. The Foundation for Accreditation for Cellular Therapy standard specifies that 72 hours is the maximum amount of time a laboratory should set for transportation to a private bank in order to qualify for automatic processing and storage. A long delay could result in losing all of the therapeutic potential of a cord blood unit, which is why we recommend parents call us immediately after delivery so that a medical courier can be dispatched to your hospital room to pick up the cord blood as soon as possible. The standard mobilization time of a specialized medical courier requires 2-3 hours from phone call after delivery to specimen pickup at the labor and delivery suite; so long delays in contacting us post-delivery should be avoided.

How will I know my cord blood collection was received by Core23?

Once your child’s cord blood unit is received at our facility, you will be notified that your collection(s) has been transported safely to our processing and storage facility. This is when we begin the processing and testing of your collection, which can take between 30-45 days.

When will I know that my cord blood collection was successful?

We will send you a storage certificate and testing report card after your cord blood, tissue, and plasma has been processed, tested, and stored. The storage certificate is sent out after receiving 48 hour sterility results and the testing report card is send out six weeks after delivery when final testing results have been received.

Do we operate our own storage facility?

Yes, we not only have our very own state-of-the-art processing and testing laboratory, but we also own and operate our very own secure long-term cord blood storage facility. Less than half of private cord blood banks operate their own facilities, but we felt it was important to have your families’ collections on-site to ensure its safety.

What type of backup systems does facility have in case of power failure? Disasters?

We have a full disaster preparedness plan, including preparation for bad weather, inconsistent power supply, and environmental changes by having battery backup systems which makes electricity available within a fraction of a second. These backup systems are also on the most critical key equipment in our processing facility, such as the liquid nitrogen monitoring systems, security & safety monitoring systems, and computer & testing equipment so that nothing will interfere with the safe and secure long term storage of your family’s precious stem cells. Even our building was specially chosen due to our laboratory area being built into the side of a large hill, minimizing the risk of from inclement weather.

What happens to my cord blood storage if Core23 shuts down?

In the unlikely event of cessation of business practices, Core23 BioBank has established a preparedness and contingency plan to quickly and safely transfer any banked units to another accredited laboratory facility for continued safe, secured, and constantly monitored long term storage facility for the future protection of your family’s precious stem cells. In this event, you will be immediately notified by both Core23 BioBank and the new long term storage facility of this change as well as be provided with current and future contact information for both institutions for future annual storage fee payments.

How much cord blood is needed for a transplant?

It takes hundreds of millions, even billions of cells to be clinically therapeutic. This is why it is extremely important for each expecting parent who decides to cord blood bank to emphasize the desire for three cord vein punctures while maintaining sterility to the collecting physician which may be different than your office OB/GYN. We feel very strongly that the third puncture of the umbilical cord vein is by far most important; the closer the collection is to the placenta the better! We make sure to include specific physician instructions with your collection kits, as well as sending information to your OB/GYN prior to delivery. However, your OB/GYN is not always the physician that delivers the baby, so it is important to remind the physician and staff about the 3 punctures.

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