Our Operating Process
Cord blood is collected at each one of our collection sites by trained in-house staff. Minutes after childbirth and after the umbilical cord is cut, the placenta and its attached portion of the cord are delivered. With previously established maternal consent to collect the cord blood, our staff moves the placenta to a dedicated adjacent laboratory room, where they collect the cord blood into a sterile plastic bag, much like those used for blood transfusion.
Because we collect cord blood from the delivered placenta, there is no risk to mother or newborn. Well after delivery is complete, one of our nurses then explains all the detailed aspects of our program to the mother and requests her consent to donate the cord blood. A full informed consent is required by our program in order for us to store donated cord blood. The cord blood collected from a single placenta becomes a unique cord blood unit.
Once each day, cord blood units are transported from our collection sites to our cGMP manufacturing facility. Several small samples are removed for typing and testing and the unit is processed for freezing and storage. We remove excess red blood cells and plasma using the AutoXPress (AXP) system we developed with ThermoGenesis, to reduce the volume of each cord blood unit to exactly 20ml. That volume contains nearly all of the mononuclear blood cells present in the original collection, including the hematopoietic (blood-forming) stem cells. We combine this cell suspension with a preservative (DMSO) that protects the cells from damage during freezing. The “cryoprotected” cells are then transferred to a specially designed freezer bag and sealed into an overwrap bag for individual quarantine in a BioArchive™ (ThermoGenesis) freezer.
Freezing & Storage
Cord blood units are frozen and stored at -196°C in liquid nitrogen freezers designed especially for cord blood. The BioArchive is a robotic freezer that controls and monitors the rate of freezing, then stores the unit submerged in liquid nitrogen and provides quick access to stored units whenever needed, all under computer control and with complete documentation of every action and unit status throughout its storage lifetime.
When a transplant center requests a matched cord blood unit for a patient, our available inventory of cord blood units is “searched” for matches to the patient. The best matching unit (or units) can be selected, reported, confirmed and delivered rapidly upon request.
Teams at most major transplant centers submit “Search Requests” directly to our program on behalf of their patients. In addition to using our proprietary online search platform called Web Search, transplant centers have two other means for searching NCBP's inventory:
- The National Marrow Donor Program (NMDP) operates the Be the Match™ Registry which serves as the single point of access for the National Cord Blood Inventory (as described under the federally-sponsored C.W. Bill Young Cell Transplantation Program). Out entire clinical inventory, including those designated for the National Cord Blood Inventory, is represented in the Be the Match™ search database.
- The World Marrow Donor Association (WMDA) maintains an international catalogue of bone marrow donors and cord blood units, and its search engine finds matches and provides requesting transplant centers the IDs and banks (or registries) of the matched bone marrow or cord blood donors.
Like our program, these international registries are also able to coordinate the identification and transport of cord blood units between local, national and international cord blood banks and transplant centers.
When a matched unit list is forwarded and the patient's transplant physician decides to proceed to transplant, our program then confirms the HLA typing of both the cord blood unit (at no extra charge to the patient). Confirmatory typing of the cord blood is performed on a sample of the unit’s contents using sealed tubing segments, integral to the freezing bag. This confirmation ensures that no mistakes were made in the labeling or HLA typing of the unit. Once the unit’s information is demonstrated to be correct and the unit is ordered for the patient, it is shipped in a liquid-nitrogen-cooled container (dry-shipper) which is equipped for continuous monitoring of the internal temperature. The transplant center receives the unit before the patient begins the preparatory treatment for the transplant. Thus, the transplant center can be assured that the unit arrived in good condition without putting the patient at any risk.