- Why is an AABB-accredited bank important to you?
- What is cord blood?
- What are Hematopoietic Stem Cells (HSCs)?
- Why transplant stem cells?
- What is the difference between cord blood and bone marrow transplants?
- What kinds of diseases can be treated with cord blood stem cells?
- Why save cord blood?
- What is the chance of using cord blood?
- Who else can use my baby's cord blood?
- Should I bank cord blood for each of my children?
- How much cord blood is needed for a transplant?
- Can a successful transplant of cord blood be guaranteed?
- How is cord blood collected?
- What should I do after the cord blood is collected?
- How do I know if the cord blood has been received by Progenics?
- How is cord blood processed?
- When should cord blood be processed after collection?
- How do I know if the cord blood has been successfully processed?
- How is cord blood cryopreserved?
- How is cord blood stored?
- How long can cord blood be stored?
- Does Progenics use my baby's cord blood for research?
- Should I transfer my baby's stored cord blood if I move?
- How do I retrieve the cord blood when I need it for treatment?
- How do I register with Progenics?
- What is the cost of cord blood banking?
- How soon should I register with Progenics?
- What should I do after registering with Progenics?
- What should I do after the cord blood is collected?
1. Why is an AABB-accredited bank important to you?
| AABB (American Association of Blood Banks) accreditation is important because it indicates that Progenics meets the standards set out by an international organization in terms of excellence, quality, and commitment to continuous improvement to achieve the highest possible standards in cord blood banking. There are only a few AABB accredited facilities in Canada! |
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Who is the AABB?
The American Association of Blood Banks (AABB) is an international association of blood banks, including hospital and community blood centers, transfusion and transplantation services, and individuals involved in activities related to transfusion and transplantation medicine. Since its inception in 1947, the AABB continues to support the highest standards of medical, technical and administrative performance, scientific investigation, clinical application and education. The association is dedicated to encouraging the voluntary donation of blood and other tissues and organs through education, public information and research. The AABB member facilities are responsible for collecting virtually all of the nation's blood supply and transfusing more than 80 percent. Nearly 2,000 institutions (community and hospital blood banks, hospital transfusion services, and laboratories) and about 8,000 individuals are members of the AABB, including physicians, scientists, administrators, medical technologists, blood donor recruiters and public relations personnel. Members are located in all 50 states and 80 countries. The AABB's active membership provides direction to the association through its board of directors and more than 30 committees of dedicated volunteer professionals.
What is the AABB Accreditation Program?
The AABB Accreditation Program promotes the highest standard of care for patients and donors in all aspects of blood banking, transfusion medicine, hematopoietic (blood stem cells like cord blood), cellular and gene therapies, and transplantation. This is accomplished by the administration of accreditation activities in a competent and reliable manner that fosters improvement in laboratory and transfusion medicine settings. It is the intent that the accreditation granted and the services covered by the accreditation be recognized at a national and international level.
How is a Cord Blood Bank Accredited by the AABB?
Accreditation follows an intensive on-site assessment by specially trained experts who have many years of education, experience, and research in these fields. The AABB accreditation personnel evaluate the policies and procedures to ensure that the level of medical, technical and administrative performance within the facility meets or exceeds the standards set by the AABB. The assessment includes the donor evaluation process, transportation of cord blood to the processing laboratory, cell processing, calibration and validation of processing and storage equipment/instrumentation, cryopreservation/storage records, document control, inspection and testing, training of laboratory technologists, sample identification and traceability, and verification of cord blood units when released from storage.
What Does it Mean to be AABB Accredited?
Having AABB accreditation means that a particular blood bank has achieved a high level of commitment, quality and efficiency in their procedures and practices. There is a guarantee that cord blood that is banked at a facility with AABB accreditation has been processed and stored properly and that quality is assured as meeting or exceeding the standards set out by the AABB. Because accreditation by the AABB is voluntary, any company that seeks endorsement by them is looking to continuously improve their procedures in order to attain the highest level of quality possible.
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2. What is cord blood?
After a baby is delivered, the umbilical cord
is clamped and cut, close to the baby's "belly-button". In the remaining umbilical cord that is still attached to the placenta, there is about 100mL of fetal blood, known as "cord blood". This "left-over" blood is traditionally discarded with the placenta as biological waste. However, scientists have discovered that cord blood is very rich in a special kind of cells called Hematopoietic Stem Cells(HSCs).
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3. What are Hematopoietic Stem Cells (HSCs)?
HSCs are pluripotent cells with an unlimited capacity for self-renewal. They continuously replicate and differentiate into all the components of the blood and immune systems. Every day, HSCs produce billions of red blood cells, white blood cells, and platelets that are essential for our health. The three sources of hematopoietic stem cells which are routinely used for medical treatments are:
- Bone marrow
- Peripheral (circulating) blood
- Cord blood
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4. Why transplant stem cells?
Sometimes, the HSCs in the bone marrow may become diseased (malignant or non-malignant), or may be destroyed by cancer chemotherapy and/or radiotherapy. When this occurs, stem cell therapy is essential.
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Traditionally, the source of HSCs is the bone marrow, hence the term "bone marrow transplant". However, umbilical cord blood is another very important source of these precious life saving stem cells. In fact, researchers have discovered that cord blood-derived stem cells have many advantages over bone marrow-derived stem cells and are preferred in transplants.
The concept of the stem cell transplant is very simple. Stem cells from one person are transplanted to another whose bone marrow has been damaged from disease or cancer treatment, like chemotherapy and/or radiation. Patients can also donate their own stem cells for use after chemotherapy.
Hematopoietic Stem Cells are capable of developing into all the specific types of cells in the blood and immune systems. For some diseases stem cell transplants are a standard treatment. For some diseases they are the only therapy, and in some other diseases they are only employed when front-line therapies have failed or when the disease is very aggressive.
When a patient requires a stem cell transplant, the attending physician will decide which source of stem cells to use. This will depend on several factors, including but not limited to: the degree of HLA match between donor and patient (sometimes the donor and patient are the same person), the expected speed of engraftment (number of available cells), and the amount of time available to search for a perfectly matching donor. Over 8000 cord blood transplants have been performed worldwide.
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5. What is the difference between cord blood and bone marrow transplants?
Transplantation using stem cells derived from cord blood rather than bone marrow has many advantages. These include immediate availability, a painless and non-invasive collection process, a lower risk of infectious complications, a much superior proliferative capacity, a greater tolerance for tissue mismatch and most importantly, a significantly reduced risk of fatal post-transplantation "graft-versus-host" disease. This is because cord blood stem cells are more immunologically immature and thus more tolerant than bone marrow stem cells.
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6. What kinds of diseases can be treated with cord blood stem cells?
More than 70 diseases have been successfully treated with stem cells. These include cancers (leukemias, lymphomas, myelomas), blood disorders (thalassemias, sickle cell anemia, Fanconi's anemia), and immune deficiency diseases.
Details of Stem Cell Treatable Diseases
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7. Why save cord blood?
Cord blood transplantation has saved the lives of thousands of patients worldwide since 1988, when a patient with Fanconi anemia received his sister's cord blood at age 6. Now the patient is currently healthy with a complete long-term hematologic and immunologic donor reconstitution.
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There are three good reasons why we should save the cord blood stem cells:
1. Autologous (self-derived) cord blood stem cell transplantation:
The cryopreserved stem cells may be used for the child from whom the cord blood was originally collected. Hence, banking the child's cord blood provides a "biological insurance" for the health of the child, in case he or she may one day need stem cell therapy. In this situation, a perfectly matching supply of stem cells will be immediately available.
2. Allogeneic (non self-derived) cord blood stem cell transplantation:
Since there is a high likelihood of a good tissue match, the cryopreserved stem cells collected from a child may also be used for other family members. Even with an imperfect match, there is a much higher chance of a successful transplant when using cord blood stem cells from a close relative rather than bone marrow stem cells. To date, many children with leukemia and other diseases have been saved by cord blood previously collected from their siblings.
3. Banking on the future of cord blood stem cells:
Umbilical cord blood stem cells have enormous potential for treating many diseases other than those of the blood and immune systems. Research has shown that umbilical cord blood stem cells may differentiate into many other types of tissue, such as nerve cells, heart muscle cells, and insulin-producing pancreatic cells. In the future, stem cell therapy may help to regenerate an injured spinal cord, repair a diseased heart, or cure diabetes. This is probably the most important reason to bank cord blood. Since cord blood stem cells can be cryopreserved indefinitely, saving a child's cord blood today may be an important investment in his or her future health. It is not an unrealistic expectation that such advanced stem cell technology may become a reality during the lifetime of the child whose cord blood has been stored.
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8. What is the chance of using cord blood?
The chance of a person using his or her own stem cells is 1 in 400 (0.25%) over the course of their lifetime and the chance of transplanting cord blood stem cells to siblings has been 17 out of 506 donors (3.4%) (Reed W. et al. Transfusion 2003; 101: 351-357). However, the chances of using cord blood stem cells will be increased significantly with advanced research in stem cell therapy.
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9. Who else can use my baby's cord blood?
Your baby's cord blood is stored for the use of your family only. A sibling has the best chance of being a perfect match (about 1 in 4) and the chance of a transplantable match is much higher. Parents and other family members have a chance of matching a cord blood unit as well.
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10. Should I bank cord blood for each of my children?
There is a 1 in 4 chance for a child to match a sibling perfectly. Therefore, it makes sense to save cord blood stem cells from each child to increase the probability of matching a family member who might develop a disease requiring stem cell therapy.
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11. How much cord blood is needed for a transplant?
A successful transplant is closely related to the number of cells in the cord blood being transplanted, not the volume of cord blood. The optimal amount of cord blood for a transplant is defined as 2 x 107 (Tse and Laughlin, Hematology (Am Soc Hematol Educ Program) 2005; 377-383) nucleated cells per kilogram of the recipient's body weight. Transplanted nucleated cells lower than 1 x 107 / kg delay engraftment and increases probability of failure.
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12. Can a successful transplant of cord blood be guaranteed?
Not really, because a successful transplant is determined not only by the quality of the cord blood cells but by the condition of the recipient as well.
However, a successful transplant does correlate with the cell dose of total nucleated cells (TNC) administered to the patient. Because a small volume and low cell count of cord blood limit its application, the yield of TNC (recovery (%) of nucleated cells) from processing (saving more cells) plays a role in determining the success of a transplant. When comparing results from different cord blood banks (Moroff G et al. Transplantation and Cellular Engineering (46) 507-515, 2006) the cell count of nucleated cells is the most reliable indicator because it is the least variable. Therefore, a successful transplant can be guaranteed by extracting a higher cell dose from processing if conditions of patients are similar.
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13. How is cord blood collected?
You will be provided with our special collection kit that makes the procedure safe and simple. After your baby is delivered and the umbilical cord is clamped and cut, your doctor or midwife will collect the cord blood from the umbilical cord in a collection bag. After collection, the cord blood will be couriered to our laboratory for processing. It is a painless process for both mother and child.
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What is the average collection volume without anticoagulant (mL)?
For a public bank, about 50% of collected cord blood samples are discarded and the average volume is dependent on a cut off volume. Normally the average volume is about 75 mL without an anticoagulant. However there is no report about collection volume available for a private bank. It is very important to have enough cells for a successful transplant. An investigation on banking sibling cord blood for transplantation shows an average collection volume of 68 mL with a transplantation rate of 3.4% (Reed W. et al. Transfusion 101: 351-357 (2003)).
Average volume received by Progenics is 78 mL without anticoagulant.
• What is the minimum cord blood volume accepted for storage?
There should not be a minimum volume for storage because any volume might be useful if cord blood could be expanded a few hundred fold in the future. However, a recommended minimum volume should be set since it is costly to store the cord blood, while chances of usage are few based on current standards. From a study of sibling cord blood banking, 20 mL or 300 x 106 nucleated cells should be an acceptable minimum for banking (Reed W. et al. Transfusion 101: 351-357 (2003)).
Minimum volume eligible for processing at Progenics is 40 mL without anticoagulant and the number of nucleated cells is 300 x 106. Over 93% of samples received by Progenics were over 40 mL. If the volume is below 40 mL, Progenics will provide information on the sample and the final decision will be made by the family.
• What is the discard rate if there is an acceptable minimum volume?
Nearly 50% of collected cord blood samples are discarded from public cord blood banks but no information is available from private banks. From a sibling cord blood banking study, 34/540 cord blood samples were discarded (Reed W. et al. Transfusion 101: 351-357 (2003)).
At Progenics less than 1% of samples below 40 mL have been discarded.
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14. What should I do after the cord blood is collected?
Follow the instructions given to you at the time of registration for transporting the collected cord blood to Progenics: Call and inform the Progenics office within 3 hours of your child's birth that your child's cord blood has been collected and is ready for pickup from the delivery hospital in the Greater Toronto Area (GTA).
If courier pickup is required from a delivery hospital other than North York General Hospital, call the designated courier service number to arrange for cord blood pickup as soon as possible. (Details regarding courier service would have been given to you at the time of registration).
Leave a message with the Progenics voice messaging system if it is off work hours or your call is not answered. Our staff will check for voice messages periodically, even when the office and front desk are closed.
Call the Progenics office under any emergency circumstances.
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15. How do I know if the cord blood has been received by Progenics?
You will be notified by our office as soon as the cord blood is received and/or processed.
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16. How is cord blood processed?
Cord blood is processed to make it usable for future transplantation. Most cord blood banks perform volume reduction in the processing procedure. Volume reduction is essentially the removal of most of the red blood cells and some plasma, leaving behind nucleated cells, which includes stem cells (approximately 0.37% of nucleated cells are stem cells). Since the number of nucleated cells in cord blood is the most predictive factor of a successful transplant, a good processing technique to save more stem cells is critical to contributing to that success. With Progenics' processing procedure, over 94% of the red blood cells are removed and the average yield of total nucleated cells from processing is 95%. The average time between collection and processing is 12 hours.
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What is an acceptable time frame between collection and processing?
Acceptable time frames between collection and processing are defined differently depending on the bank. Usually, 48 hours after collection is the limit for most cord blood banks but the shorter the storage time before processing, the better.
At Progenics the average time between collection and processing is 12 hours. If a sample of cord blood is received after 48 hours from collection the viability will be assessed to determine whether the cord blood is still eligible for processing and storage.
Is there a risk that the cord blood will become contaminated during the processing procedure?
Progenics uses a closed system during the processing procedure. A processing system is said to be closed when there is no chance for the cord blood to be exposed to air during processing. Closed system processing is the most efficient and effective procedure to prevent microbial contamination.
Progenics uses a closed system to process all cord blood samples.
What is the yield of nucleated cells after processing?
The number of total nucleated cells is the most important indicator of a successful transplant. The disadvantage of cord blood is a lower number of cells compared to bone marrow due to the smaller volume. The more cells that are lost during processing, the less chance there is for the transplant to be as successful in larger patients. During processing, 20-40% of total nucleated cells can be lost. The yield, in terms of percentage, is the number of nucleated cells left after processing, divided by the number of cells before processing, and then multiplied by 100.
With the superior double processing technique developed by Dr. H. Yang et al, the average yield of total nucleated cells at Progenics is over 95%.
What percentage of red blood cells is removed during processing?
The concentration of red blood cells left in the final product after processing is overlooked by less experienced cord blood banks. A study demonstrated that a high concentration of red blood cells (Hematocrit =0.36) can damage up to 1/3 of cord blood stem cells during cryopreservation. During optimal cryopreservation, ice only forms EXTRACELLULARLY and not intracellularly. Intracellular ice formation directly damages cord blood stem cells but extracellular ice only damages cells when the concentration of red blood cells is very high, causing what is known as "the packed effect."
With Progenics' processing procedure, 94% of the red blood cells are removed, and the average hematocrit is 0.08.
What is the average number of total nucleated cells after processing?
The yield is a critical factor for good processing of cord blood but it has to be verified by the number of total nucleated cells per unit.
Average total nucleated cells after processing at Progenics was 1,080 x 106/sample
Is the processing method published in a scientific journal?
If published, the processing procedure of a bank has already been systematically investigated; therefore, it should be safe and efficient to be used for processing cord blood.
The processing protocol was developed by Dr. H. Yang et al and is published in Bone Marrow Transplantation (2001) 27:457-461.
Does double processing injure more stem cells than the conventional processing technique?
No, the viability of stem cells after double processing was 97.1%.
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17. When should cord blood be processed after collection?
Within 48 hours. However, the shorter the period before processing begins, the higher the quality of the cord blood
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If the sample is over 48 hours old (from the time of collection), the viability of cord blood needs to be assessed to determine whether the cord blood is suitable for storage. Usually, Progenics cord blood samples are processed within 12 hours after collection.
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18. How do I know if the cord blood has been successfully processed?
You will be notified by Progenics.
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We will contact you and provide you with information about the cord blood if the volume is below our cut-off volume (40 mL) and cut-off cell count (300 x 106 total nucleated cells per cord blood sample.) If the cord blood sample is less than the cut-off volume AND cell count and you decide to bank your baby's cord blood, you will receive 50% off the processing fee and 50% off the storage fee for 5 years. After 5 years you will pay the regular storage fee. If the cord blood is above the cut-off values, you will receive a confirmation letter after Progenics has obtained all of the results for both the maternal viral marker blood tests and the cord blood microbiological tests. The letter will confirm the successful processing and storage of your child's cord blood. You should expect to receive this confirmation about 8-10 weeks after the birth of your child.
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19. How is cord blood cryopreserved?
Basically, the cryopreservation procedure includes the addition of a 5-10% Dimethyl Sulfoxide (DMSO) solution with freezing at a rate of around 1°C/min using a controlled rate freezer.
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Almost no cells can survive freezing without an optimal cryopreservation process. The cryopreservation of cord blood started out as a purely empirical approach that was initially successful in the cryopreservation of bone marrow. It was gradually adapted for the cryopreservation of cord blood. Basically, the cryopreservation procedure includes the addition of a 5-10% dimethyl sulfoxide (DMSO) solution with freezing at a rate of around 1°C/min using a controlled-rate freezer. The controlled-rate freezer is a proven and commonly used piece of equipment for cryopreserving cord blood. Most, if not all, transplanted cord blood samples are cryopreserved using this cryopreservation technique.
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20. How is cord blood stored?
At Progenics processed cord blood is stored in the vapor phase in a liquid nitrogen freezer, where the temperature is <=-180°C.
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Normally cord blood stem cells are cooled down slowly from above 0°C to -60°C, and then transferred to a liquid nitrogen freezer for long term storage. When cord blood is stored in a liquid nitrogen freezer, it is very stable in either the vapor phase or liquid phase. The critical temperature for storing cord blood is -130°C. If a sample reaches a temperature higher than -130°C during storage, the cord blood can be damaged by intracellular recrystallization. Therefore, it is critical that the temperature of the storage freezers be monitored 24 hours a day and the contents of malfunctioning storage freezers be easily transferable to a back-up freezer immediately. At Progenics, processed cord blood is cryopreserved using a controlled-rate freezer and then stored in a liquid nitrogen freezer, where the temperature is -180°C or lower. A backup liquid nitrogen freezer is available at all times in case of an emergency.
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21. How long can cord blood be stored?
Cord blood stem cells have demonstrated the ability to be stored for at least 15 years in liquid nitrogen without significant damage (Broxmeyer He et al. Proc Natl Acad Sci USA 2003; 100: 645-650). Theoretically the cells can be stored in liquid nitrogen for up to 2000-4000 years.
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The dose of ionizing radiation that kills 63% of representative cultured mammalian cells at room temperature is 200-400 rads (Elkind M and G. Whitmore: The radiobiology of cultured mammalian cells. New York : Gordon and Breach, 1967). Because terrestrial background radiation is approximately 0.1 rad/yr, it should require 2000-4000 years to kill that fraction of a population of typical mammalian cells at -196°C. Stability for centuries or millennia requires temperature below -130°C. TOP
22. Does Progenics use my baby's cord blood for research?
No, your baby's cord blood is stored for your family's use only. Any research is carried out with cord blood donated from voluntary donors with informed consent. All research is directly related to the improvement of banking cord blood.
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23. Should I transfer my baby's stored cord blood if I move?
No, it is best to keep your stored cord blood in the bank since transferring it from one location to another does hold a risk of losing the sample to a variety of potential accidents during transportation. Therefore it is better to keep the sample at the processing laboratory and it is transferred when the stored cord blood is needed for treatment of a disease. The transportation will be arranged by Progenics and the transplant facility. The stored cord blood can be shipped to nearly anywhere in the world.
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24. How do I retrieve the cord blood when I need it for treatment?
If a member in your family becomes ill with a disease that can be treated with stem cell transplantation, the attending transplant physician, with your authorization, will contact us for information about the stored cord blood. If the physician decides to proceed with a transplant using that cord blood unit, he or she will send us a request along with your consent for the shipment of the unit to the transplant center.
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25. How do I register with Progenics?
You have three options for registering with Progenics.
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26. What is the cost of cord blood banking?
Please see Schedule of fees
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27. How soon should I register with Progenics?
We highly recommend our clients to register at least TWO months before their expected due date. In certain circumstances you still can register with Progenics as long as there is enough time to deliver a collection kit to you before you give birth to your baby. Simply call the Progenics office for further details regarding the registration process.
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28. What should I do after registering with Progenics?
Keep the cord blood collection kit at room temperature. Remember to bring the cord blood collection kit to your delivery hospital and give it to your attending labour nurse when you are admitted to the Labour and Delivery Ward (or Birthing Unit).
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You will be provided with a cord blood collection kit once you register with us and the registration is approved. If you register online or by fax or mail we will send the collection kit to you via courier within 3 business days or two months prior to your delivery date. Keep the cord blood collection kit at room temperature. Do not leave it in your car for an extended period of time. Remember to bring the cord blood collection kit to your delivery hospital and give it to your attending labour nurse when you are admitted to the Labour and Delivery Ward (or Birthing Unit).
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29. What should I do after the cord blood is collected?
Follow the instructions given to you at the time of registration for transporting the collected cord blood to Progenics:
(1) Call Progenics at 416-221-1666 or 1-866-921-1666 to inform us of the following:
• The Progenics Client ID #
• The mother's name
• The delivery date/time
• The delivery hospital
• A phone number that we can reach you at all times
(2) Call courier to pick up cord blood
For births at North York General Hospital, no courier is necessary. The cord blood samples will be picked up by Progenics staff.
For all other hospitals in the GTA and surrounding areas, please call our 24-hour designated courier at 416-818-2111 to arrange for cord blood pick up.
For out-of-province deliveries, please call Air Logistics at 1-866-882-8865 to arrange for special courier service.
For other delivery facilities (hospitals) please follow the instructions given to you at registration or call Progenics at 416-221-1666 or Toll free number 1-866-921-1666 for transportation instructions.
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