Frequently Asked Questions Answered

If you don’t see the answer to your particular question below please don’t hesitate to reach out to our very friendly Core23 Biobank staff it would be our pleasure to visit with you and answer all your questions!

Image

Core23 Biobank FAQs

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.
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.
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.
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.
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.

Science and Banking FAQs

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.
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. 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.
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.
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.
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.

FAQs About the Process

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.
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.
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.
If a situation arises that the stored stem cells could be used in treatment all you need to do is contact us, or let your doctor know and they can contact us. A couple more tests will be performed once we get the collection out and if everything still looks good we can ship it to any hospital or clinic for use.
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.
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.
 

Core23 Biobank is Fully Compliant with all FDA Regulations and Industry Best Practices


Why does the FDA exist?

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

What is the most important regulation that applies to human stem cells?

The single most important regulation that applies to all human stem cell products, like cord blood, is Title 21 Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products.

How do we not only meet, but exceed all of the FDA regulations?

Below are some of the many FDA regulations that govern all cord blood banks and how Core23 Biobank satisfies those regulations above and beyond!

During the enrollment process, the expecting parents will complete questionnaires about family medical history and travel to known areas of increased disease transmission risk. Additionally, your health care provider will fill out a form about the health of both mother and baby at the time of delivery. See the regulation.
Maternal blood is tested in a clinical laboratory for communicable diseases. Maternal blood is tested for hepatitis B, hepatitis C, human immunodeficiency virus, human T-lymphotropic virus, red blood cell antibody, cytomegalovirus, Treponema pallidum, West Nile virus and Trypanosoma cruzi. See the regulation.
A maternal blood sample is typically collected on the day of the baby’s delivery and sent with the collection kit for the required tests to be performed. In the unlikely event there is a problem with the maternal blood collection, we coordinate with families to ensure the collection is obtained within the specified time limit of 7 days before or after the umbilical cord collection. See the regulation.
Core23 Biobank has specific employees that are tasked with monitoring and evaluating the processes and procedures (some outlined below) governing the operations of the facility via internal audits to ensure FDA compliance. See the regulation.
All laboratory staff members are evaluated on the basis of their education and experience prior to hiring and documented in their résumés or curriculum vitae. Staff undergo a training program after hiring which is refreshed on an annual basis and monitored through tracking software that ensures personnel are current on all policies and procedures. See the regulation.
All procedures are designed to prevent the risk of communicable disease transmission. Examples of this include the use of a closed system during processing and cryopreservation, unique identification labels and barcodes, double barrier layers around freezer bags and single-use reagents. Every procedure is validated through the quality program system before implementation. See the regulation.
In addition to design aspects of the Core23 Biobank facility, like the workflow layout, airflow, and security access control, the facility is rigorously cleaned before and after each processed umbilical cord unit. Documentation logs of cleanings and filter changes ensure that the processing facility is maintained to the highest order. See the regulation.
The Core23 Biobank processing facility, refrigerators, and cryogenic storage tanks are continuously monitored by wireless sensor nodes distributed throughout the facility which would alert staff of any area outside of specified temperature or humidity range. Additionally, the processing facility undergoes periodic testing for air particle levels and microorganisms. See the regulation.
All processing equipment is cleaned and sanitized before and after every umbilical cord unit. All equipment is calibrated also inspected and certified by a third-party (non-Core23) service professional. Documentation of all activities are maintained through our online tracking software. See the regulation.
All supplies, reagents, and their manufacturers are vetted before purchasing any item. All supplies and reagents must pass a documented quality check before they can be put into our tracking system for use. Our system allows us to know the lot number and manufacturer of every item used in the processing of each individual umbilical cord unit. See the regulation.
Each umbilical cord unit is assigned its own unique Core23 identification number and barcode. That unique identifier is used to identify each specific cord blood product on everything from the collection kit to the final freezer bag that goes into the storage tank. In this way, Core23 biobank prevents any possible risk of mix-ups. The unique identifier also provides a way to link the umbilical cord product with all the relevant information obtained throughout the donor screening and testing processes as well as in-process product testing. Additionally, the final label put on the cord blood freezer bag also contains information, like cryoprotectant concentration and storage conditions, that will be useful to transplant physicians. See the regulation.
All samples are tested for microbial contamination as well as before and after processing to determine stem cell enrichment. All our processing procedures have been validated and verified at our facility using our equipment. Because we are committed to producing a quality product, Core23 Biobank has never pooled anything from separate collections ever. See the regulation.
Our storage tank resides in a secure, access-restricted room. Freezer bags are enclosed in two layers of protective material to prevent any possibility of cross-contamination. Each product is labeled with a unique identification number and barcode to prevent any possible mix-ups. The freezer bag label also includes information about the method of preservation which will be important for any potential therapeutic use. The storage tank temperature is monitored and recorded continuously using wireless sensor nodes. See the regulation.
Every umbilical cord unit is evaluated upon arrival for any potential sign of damage or contamination. All units are quarantined until all test results have been evaluated. In the event that a unit is needed, our medical director works with the transplant physician to ensure the transplant physician and facility know every detail about the unit and are prepared for its timely arrival at the transplant facility. All stem cell shipments are continuously temperature monitored and will follow a strict chain of custody procedure during their entire trip between Core23 Biobank and the transplant facility. See the regulation.
Core23 Biobank operates a sophisticated document tracking and record management system. All aspects of our operations, including procedures, test results, questionnaires, and product information, are stored in a secure cloud-based system in addition to our physical records. This system ensures that all of our records will be maintained well beyond the minimum set by the FDA. See the regulation.
Our tracking software and Core23 unique identification number allows us to track every aspect of the product, from initial collection to storage and distribution for use. See the regulation

Learn About Cord Blood Banking Services



Explore these informational resources below to learn more about Core23 Biobank Cord Blood Banking services.



Testimonials

“I banked my daughter’s cord blood and chose Core23 because my doctor recommended them.” – Gibson Family

Testimonials

About Core23

Core23 Biobank was founded by a group of experts in the field of cord blood banking and regenerative medicine.

About Core23

For Families

Related stem cell products are very important when evaluating the genetic compatibility of a therapy.

For Families

Private Banking

There are three options for umbilical cord stem cell banking here you can explore and pick the plan that is right for you.

Private Banking