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Processing and Banking of Adult Peripheral Blood Stem Cells
1. Where are my stem cells stored?
Our laboratory and storage facility is located in Chicago, Illinois. We have chosen this storage site for many reasons including safety from environmental disasters, such as hurricanes, floods, earthquakes and other natural disasters, as well as the state-of-the-art laboratory in which the stem cells will be stored.
2. How do I know my stem cells are stored safely?
Our laboratory is overseen by Cord Blood America, Inc. 1.888.882.2673.
3. How is my blood processed?
- Upon receipt at our laboratory, the container holding the adult peripheral blood specimens will be checked, verified and computer entered.
- The blood will be tested for communicable diseases.
- The blood is centrifuged, fractionated (i.e. blood fractions separated) and will undergo a series of blood and cell marker tests to 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, AdultCells will send you specific results of the blood cell testing
4. What testing is performed by Adult Cells?
Upon receipt of the collected adult peripheral blood specimens, the collected blood will undergo a battery of laboratory tests and assays. The specimen 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 virology testing to screen for the presence of any infectious diseases. Once determined that the adult 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.
5. How long can blood stem cells be stored in liquid nitrogen?
Scientific studies indicate that stem cells can be cryogenically stored indefinitely. Information reported by the New York State Department of Health and others show that when stored at minus 196 degrees Celsius (i.e. cryopreserved in liquid nitrogen) in an undisturbed manner, stem cells do not lose their viability or biological activity. Transplants have been conducted with stem cells that have been cryopreserved for 15 years.
6. Does Adult Cells perform HLA typing on my blood samples?
AdultCells 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.
7. Will I receive confirmation that my blood has been stored successfully?
Yes. Your Certificate of Specimen Deposit will arrive once your specimen has successfully been cryopreserved and stored with our lab.
8. 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 AdultCells, your collection kit is assigned a unique identifier, and this same identifier always remains with your blood kit, paperwork, and sample.
- A second identifier is a unique I.D. imprinted on each vial.
- Third is the storage location of your unique sample. This information is stored in our computer system, which is backed up daily, via optical disk and a hardcopy system.
9. What 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 and New Jersey have mandatory licensing and strict regulations on cell blood banking. The stringent laboratory processes, record keeping, quality control and quality assurance of AdultCells are designed to meet federal (FDA) guidelines and regulations. AdultCells is an FDA registered laboratory and is also in a process of accreditation by the American Association of Blood Banks (AABB) and is a CLIA and CAP certified laboratory by the College of American Pathologists.
10. If my family ever needs the sample, how do we retrieve it?
Should the need arise, AdultCells’ client services department and your physician would make arrangement for confirmatory testing, release, and transportations of your stem cells to a designated hospital.
11. Is there a cost to retrieve my stem cells?
You will not be charged a retrieval fee by AdultCells. 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. AdultCells arranges for the preparation and shipment of the adult peripheral blood stem cell unit according to industry standards.
12. Does insurance cover the service of adult peripheral blood banking?
An increasing number of private health care insurers as well as state Medicaid programs have been or are considering covering stem cell blood banking. Stem cell 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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