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Processing and Banking of Cord Blood
1. Where will my baby’s cord blood stem cells stored?
Our laboratory and storage facility is located in Las Vegas, Nevada. This newly constructed 17,000 sq. ft. state-of-the-art facility’s location was chosen for many reasons including safety from environmental disasters, such as hurricanes, floods, earth quakes, snow storms and other natural disasters, as well as being located just minutes from the city’s major airport.
2. How do I know my baby’s stem cells are stored safely?
NeoCells’ Medical Director Eric Senaldi, M.D., is a nationally known figure in the field of blood collection, blood banking and cord blood collection, processing and preservation. The laboratory is overseen by Dr. Geoffrey O’Neil. Dr. O’Neil has 25 years experience in the industry, processed more than 50,000 specimens and has published 78 papers. The laboratory features 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 the laboratory 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. Is NeoCells heparin free?
NeoCells is proud to be heparin free. Our UmbiliCord™ collection kit does not contain heparin as an anti-coagulant. Instead, NeoCells uses a gentler anti-coagulant called CPD, which is approved for cord blood collection, acts as a cell preservative and is free of animal by-products. Heparin does not meet these same standards.
5. What makes NeoCells’ processing system different?
NeoCells’ processing system encompasses the best of all processing methods. It is a functionally closed bag system that prevents potential air contamination. It has the highest red blood cell depletion rate in the industry allowing for a purer concentration of critical cells. It also has some of the highest recovery rate averages of critical cells. Last and most important, our method allows for smaller samples to be processed which is not possible with many competitor’s systems.
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 and licensed in the states of CA, NJ, and NY, and our laboratory is also CLIA and CAP certified.
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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