Cord Blood Collection Kits
After the delivery, the standard procedure is to clamp and cut the umbilical cord. If the family decided to bank the umbilical cord blood, a needle is used to draw the blood from the umbilical vein to the collection bag. The collection kit is used to safely transport the umbilical cord blood from the collection site to the processing laboratory, where the samples are prepared for the cryopreservation.
Regulatory View on Collection Kits
se of the FDA approved collection kits increases and guarantees the safety and viability of the collected cord blood. Below are listed some of the very important characteristics of a cord blood collection system that FDA considers to be essential in order to establish a safe and effective cord blood collection.
Materials used in the design and construction of a collection system need to be tested for biocompatibility. These materials must not produce any toxicity when in direct or indirect contact with the patient. Within the scope of testing, the manufacturer has to provide evidence that the materials used for a production of a collection kit do not produce any unreasonable local reactions, are not carcinogenic and do not cause any reproductive or developmental defects.
- Device Performance
The performance of the collection system refers to the quality of the product prepared for a purpose to collect umbilical cord blood. Note that the umbilical cord and placental tissue are still not entirely regulated by the FDA, therefore, these collection systems may not be a subject of control of their safety and effectiveness. This also refers to a product functionality including the robustness of materials and the durability of the system. The manufacturer must ensure that the collection system will not allow leakage of the collected umbilical cord blood following collection. It is also very important that the collection system does not sustain any damage when exposed to a high range of temperatures.
- Other Important Issues
Not limited to a collection kit, but also quite important for the process of collection is how a consent is obtained and which critical procedures have to be performed to ensure the proper collection process. Obtaining a proper maternal risk and family medical history, performing maternal blood screening for infectious diseases, obtaining the consent of the mother, evaluation of the donor eligibility are the key component of a properly functioning collection system for each stem cell banking facility.
Families may choose to store the umbilical cord blood for personal use within the private banking facilities or may decide to donate the baby’s cord blood to one of the public banking systems. Some of the public cord blood banks have developed collection systems that are sent to the mother several weeks prior to the expected delivery date. Private cord blood banks use these collection systems in 100% of cases. Mothers who choose to donate their baby’s cord blood must contact their obstetrician or midwife regarding the umbilical cord blood collection. Obstetrician or midwife have to be trained on umbilical cord sampling prior to collection of the cord blood. Mothers also need to pass health history screening procedure as well as the blood test to exclude the transmission of an infectious agent.
Kit sent to the expectant mothers must contain relevant supplies for the collection of cord blood from the baby, devices for the collection of mother’s blood, detailed instructions for the healthcare professional on how to adequately perform the collection of cord blood, temperature logger, instructions on how to store the collection kit prior to collection and instructions on how to ensure a safe shipment of the sample to the processing laboratory.
Various private banking systems offer specific design of the collection kits that protect the viability of stem cells within the sample or increase the number of potential uses of the same sample.
stability is affected by temperature, which directly reduces the efficacy of anticoagulation. Development of clots has been reported with the use of heparin for anticoagulation, which directly reduced the number of viable stem cells.
The important feature of each collection kit is its’ readiness for use in both the vaginal and cesarean section delivery. Some banking systems also developed kits designed for the collection of the cord blood immediately after the baby is born, or after the delivery of the placenta. The package of the collection kit should ensure temperature stability during the kit transportation. Temperature fluctuations may affect the viability of the sample and decrease the number of transplantable stem cells.
Other institutions that monitor the quality of collection kits
Other highly respectable organizations provide guidance on how to collect and transport cord blood units. For example, AABB has rigorous operational guidance on how to perform the collection of the umbilical cord blood. AABB supports the innovative approach to design and production of cord blood collection kits. One of the key characteristics that each collection kit should contain is a sterile environment. Each step in the collection of umbilical cord blood must ensure an adequate prevention of transmission of an infectious agent. If an institution receives an accreditation from AABB, this means that the collection of samples complies with the procedures recommended by this organization. AABB also conducts regular audits and inspections of the accredited banking facility, in order to ensure that quality standards are continuously implemented.
Cord blood banks possessing the accreditation from the above-mentioned institutions may be considered as referent banks where the cord blood collection and transport are performed according to the highest standards, meaning that the quality of the sample, viability of stem cells, as well as the safety of the collection process, are ensured.
There are two steps involved in storing cord blood, step one, collection, and step two, processing. First is collection, which can be carried out in two ways, both considered safe to an equal degree. The first collection method is ex utero, a method involving the placing of the placenta within a support structure that is sterile, where the umbilical cord, already cut off and clamped, is injected using a syringe, draining the blood into a bag. The second method is in utero, meaning before the delivering of the placenta. In this method, the collection of the cord blood takes place while the midwife or doctor waits for the delivery of the placenta or in a five to ten-minute period prior to the placenta’s delivery. The procedure is the same as in ex utero, excepting the time of the blood’s collection.
Both kinds of women, those with cesarean deliveries and those who deliver their babies vaginally can donate cord blood, the procedure being equally safe in both cases. But if complications arise during the final phase of pregnancy, doctors as well as cord blood banks can choose to abandon their plans for collecting cord blood.
Side by side with cord blood collection, the mother’s blood is also collected for the purpose of detecting the presence of infectious diseases. Somewhere between 40ml and 150ml of stem cells are obtained from umbilical cords. This range of amounts is considered sufficient for transplantation. Specialists make an effort to acquire as much cord blood as they possibly can. If the blood obtained is insufficient, it is preserved nonetheless to explore possibilities of stem cell expansion and, provided that the parents’ consent, for further scientific research.
Once collected, cord blood is taken to cord blood back facilities of the parents’ choosing. The blood banks analyze and test the blood, checking for infectious diseases or to typecast the tissues.
Once the cord blood has been banked, samples of it are taken to labs within 36 and 48 hours from collection. There are differing opinions advocating different ways for processing cord blood cells. Some laboratories test the mothers’ blood for various diseases, including CMV, malaria, HIV, HLTV, hepatitis and syphilis. The processing procedure ascertains two things, firstly the status of the blood in relation to infectious diseases, and secondly, ensuring that the blood cells are capable of being used to transplant on members of the family aside from autologous use. It is typical for mothers to undergo special testing during registry of cord blood, ensuring her eligibility for the donation of cord blood. The results are communicated to parents, preparing them for treatment when required.
Some processing methods deplete cord blood of red blood cells, while others don’t. After processing, the next step is preservation. During processing, a cyropreservant is added to the unit of cord blood, enabling the unit to survive the process of cryogenics. Once the temperature of the unit drops to -90 degrees Celsius, cord blood is stored using a tank of liquid nitrogen. Special bags are divided in two compartments to preserve units of the blood, one compartment for immediate use if need be, the other for stem cell expansion.
The child’s caregivers, whether guardians or parents, have the rights to the cord blood, which they can use for their own transplants in the future. Once the child comes of legal age, s/he becomes the owner of her or his own cord blood. In case donors are concerned about issues pertaining to privacy, the blood banks offer assurances of complete secrecy, not revealing the donor’s identity to the recipient at any stage, particularly if the recipient happens to be a stranger.