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Processing and Banking of Cord Blood
1. Where are my baby’s cord blood stem cells stored?
Our laboratory and storage facilities are located in Chicago, Illinois and Paramus, New Jersey. We have chosen these storage sites for many reasons including safety from environmental disasters, such as hurricanes, floods and other natural disasters, as well as the state-of-the-art laboratories in which the stem cells will be stored.
2. How do I know my baby’s stem cells are stored safely?
Our Chicago, Illinois laboratory is overseen by Scientific Director, Anver Kuliev, M.D., PhD, one of the world’s foremost experts on cord blood stem cell banking, genetics and reproductive medicine. Dr. Kuliev is also former head of the World Health Organization Genetics Program and also currently operates the World Health Organization Collaborating Center for Prevention of Genetic Disorders. Our Paramus, New Jersey laboratory operation is overseen by Medical Director Eric Senaldi, M.D., a nationally known figure in the field of blood collection, blood banking and cord blood collection, processing and preservation. Our laboratories feature back-up generators and card access security monitoring systems that limit entry to the sequestered and secured cryogenic storage area strictly to authorized personnel. Paging, computer, and faxing systems are employed to maintain constant contact with our technicians, while monitoring the laboratory and storage areas. The facility and systems are monitored twenty-four hours a day, 365 days a year, to ensure the long-term security of your family’s stem cells. In short, we have not only secured a safe location, but our laboratories have been rigorously designed to ensure the security and safety of your baby’s stem cells.
3. How is my baby’s blood processed?
- Upon receipt at our laboratory, the container holding the maternal and cord blood specimens will be checked, verified and computer entered.
- The maternal blood will be tested for communicable diseases.
- The cord blood is centrifuged, fractionated (i.e. blood fractions separated) and will undergo a series of blood and cell marker tests to establish cell counts and ensure cell viability for cryopreservation and documentation
- If acceptable for cryopreservation and storage, the stem cells will be cryopreserved in a cryogenic storage unit at -1960 C
- After successful cryopreservation storage, NeoCells will send you specific results of the blood cell testing
4. What is the difference between automated processing and manual processing?
Currently, there are two types of processing in the cord blood market. Some companies choose to use manual processing systems while others have moved to automated processing systems.
Manual processing involves allowing the blood to sit for a period of time and then manually extracting cells from the middle of what has “settled” out from the cord blood. This method was the only method available for a long period of time and is very capable of collecting and harvesting necessary cells for transplant purposes. There are two basic problems with manual now that automated processing has become available. Manual methods only recover 40%-80% of cells necessary for transplant purposes and it is subjecting the cord blood to potential air borne contaminants. (learn more)
5. Why does NeoCells use automated processing vs. manual processing methods and why is this better?
NeoCells does not use manual methods employing Hespan or Hetastarch and Ficoll primarily because the critical cell counts retrieved for transplants are much higher with automated processing systems like the AXP and the Sepax Systems. Average cell recovery rates using automated processing systems such as the AXP are as high as 99%. Manual methods range between 40% and 80%. In addition, automation has eliminated the risk of airborne contamination and human error.
6. What testing is performed by NeoCells?
Upon receipt of the collected cord blood and maternal blood specimens, the cord blood and maternal blood will undergo a battery of laboratory tests and assays. The cord blood will be checked for blood volume and tested for blood type, bacterial or fungal contamination, CD34 marker nucleated cell counts and cell viability verification, and the maternal blood will undergo virology testing to screen for the presence of infectious diseases. Once determined that the cord blood stem cells are acceptable for cryopreservation and storage, we cryopreserve and store the specimen and provide you with a clinical report of the volume collected and the nucleated counts for the cells most critical to use in any future transplant procedure.
7. How long can cord blood stem cells be stored in liquid nitrogen?
“There is no evidence at present that [cord blood stem] cells stored at minus 196 degrees Celsius (in liquid nitrogen) in an undisturbed manner lose either in vitro-determined viability or biological activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen.”1
Stem cells can be cryogenically stored indefinitely. The longest time period in which cells have been cryogenically stored and subsequently transplanted is 15 years. Because the process of cord blood stem cell transplants is relatively new, data is limited to verify any time period longer than 15 years.
(1) Guidelines for Collection, Processing and Storage of Cord blood stem cells; New York State Department of Health.
8. Does NeoCells perform HLA typing on the cord blood samples?
NeoCells does not do HLA typing prior to specimen storage because HLA typing is not necessary until the sample is retrieved for transplant use. HLA typing prior to cryopreservation and storage of the specimen places an unnecessary additional financial burden on you. At the point in time the specimen is retrieved for transplant use, your insurance provider would cover the costs of this test for both the donor and the recipient, which will then determine if the sample is a match for the patient. The testing, assays and other quality assurance services we do on your behalf are performed to ensure specimen quantity, appropriateness for processing, cell counts and specimen viability.
9. Will I receive confirmation that my baby’s cord blood has been stored successfully?
Yes. Your baby’s Certificate of Specimen Deposit will arrive once your specimen has successfully been cryopreserved and stored with our lab.
10. How do I know that my sample will not be confused with someone else’s?
Your sample ID is ensured through an identification system:
- When you enroll with NeoCells, your baby’s collection kit is assigned a unique identifier number, and this same identifier always remains with your baby’s cord blood kit, paperwork, and sample.
- A second identifier is a unique I.D. imprinted on each vial.
- Third is the storage location of your baby’s imprinted unique sample. This information is stored in our computer system, which is backed up daily, via optical disk and a hardcopy system.
11. What AABB, federal or state guidelines or regulations do you follow?
The Federal Food and Drug Administration (FDA) have issued guidelines, and the States of New York, New Jersey and California have mandatory licensing and strict regulations on cord blood banking. The stringent laboratory processes, record keeping, quality control and quality assurance of NeoCells are designed to meet federal (FDA) guidelines and regulations. NeoCells is FDA registered licensed in the states of CA, NJ, and NY, our laboratories are CLIA and CAP certified and our NJ laboratory is AABB accredited.
12. If my family ever needs the sample, how do we retrieve it?
Should the need arise, NeoCells’ client services department and your physician would make arrangement for confirmatory testing, release, and transportations of your baby’s stem cells to a designated hospital.
13. Is there a cost to retrieve my baby’s stem cells?
You will not be charged a retrieval fee by NeoCells. You will, however, be charged for all cryopackaging preparation and shipment expenses. In most cases, however, given there is a need for the stem cells for transplant use, assuming your insurance carrier approves transplant coverage, the expenses are billable to your insurance company. NeoCells arranges for the preparation and shipment of the cord blood unit according to industry standards.
14.Does insurance cover the service of cord blood banking?
An increasing number of private health care insurers as well as state Medicaid programs have been or are considering covering cord blood banking. Cord blood banking coverage is often considered by these insurance programs when a close family member is in need of a transplant, or if there has been a documented family history of prior family member needs for a stem cell transplant for cancer, or an immune or genetic disorder. Like so many other new or relatively new medical technologies, insurance coverage for this type of service is evolving.
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