There are basically 8 steps that all cord blood banks perform in order to bank cord blood stem cells, but only two of them are key responsibilities and are related to banking quality.
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| AABB (American Association of Blood Banks) accreditation is essential for a cord blood bank to have since an accredited cord blood bank has to meet standards set out by this international organization. It is important for cord blood samples to be stored at AABB accredited cord blood banks, which are recognized by the USA’s National Marrow Donor Program (NMDP); however, if a cord blood sample is stored at a bank that is accredited by AABB, or by any other organization that provides accreditation, it does not necessarily mean that the sample can be used for a transplant when needed. Suitability of a cord blood sample for transplant is determined by the number of cells stored. Therefore, a good bank should become accredited by the AABB and in addition, should save more cells by preventing cell loss during processing. Progenics has been AABB accredited since 2005, and became accredited after being in operation for one year. |  |
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 100 mL 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 (Blood-forming) Stem Cells(HSCs). It also contains unrestricted somatic stem cells (USSC), mesenchymal stem cells (MSC) and endothelial progenitor cells (EPC), which are important stem cells that can differentiate into almost all types of specialized mature cells.
HSCs are pluripotent cells that have a capacity for self-renewal. They continuously replicate and some of them 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 (blood-forming) stem cells which are routinely used for medical treatments are:
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 has been the bone marrow, hence the term "bone marrow transplant". However, umbilical cord blood is another very important source of these precious lifesaving stem cells. In fact, researchers have discovered that stem cells derived from cord blood 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 by disease or cancer treatment, such as chemotherapy and/or radiation. Patients can also store their own stem cells for use after chemotherapy. Hematopoietic (blood-forming) 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 20,000 cord blood transplants have been performed worldwide. It has been recommended that transplanting cord blood stem cells with a perfect HLA match should be the first choice over bone marrow to treat malignant diseases (Smith A. and Wagner J. BJH147, 246–261, 2009). |
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 superior capacity for proliferation and self-renewal, 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.
Nearly 80 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.
Recently cord blood stem cells have been used in clinical trials to repair damaged tissues and organs (regenerative medicine), and the outcomes have been promising.
Cord blood transplantation has saved the lives of tens of thousands of patients worldwide. For some patients with life-threatening diseases, cord blood could be the only source of stem cells that can save their lives.
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The chance of a child using his or her own stem cells over the course of his or her lifetime is 1/400 (0.25%) (Nietfeld J.J. and Verter F., 2008). 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). The opportunities for using cord blood are expected to increase with advances in research and improvements in transplantation
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 (25-30%) and the chance of a sibling being a transplantable match is much higher. Parents and other family members have a chance of matching a cord blood unit as well.
There is a 25-30% chance that a child will 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. In addition, there could be a chance that a patient may need a transplant of two cord blood samples at the same time.
The success of a 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 nucleated cells per kilogram of the recipient's body weight (Tse and Laughlin, Hematology (Am Soc Hematol Educ Program) 2005; 377-383); therefore, saving more cells by preventing cell loss during processing is critical to ensure that the cord blood will be suitable for transplantation as time passes and the child grows. Any volume of cord blood could be useful, however, since a small volume of cord blood could be used in regenerative medicine or could be expanded in the future.
Not really, because the success of a transplant is determined not only by the quality of the cord blood cells but by the condition of the recipient as well. More importantly, the cells banked should be enough for a transplant when needed.
The success of a transplant DOES correlate with the cell dose of total nucleated cells (TNC) infused to the patient. Because a small volume of cord blood and low cell count limit its application, obtaining a high yield (recovery rate) of TNC from processing (saving more cells by preventing cell loss during processing) 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 (2006) 46:507-515), the cell count of nucleated cells is the most reliable indicator because it is the least variable. Therefore, a successful transplant should be guaranteed by extracting a higher cell dose during processing if conditions of patients are similar.
You will be provided with our special collection kit that makes the procedure safe and simple. After your baby is born 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 public banks, 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 72 mL without anticoagulant; however, there are no reports available about collection volume for private banks. 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 (2003) 101: 351-357). What is the minimum cord blood volume accepted for storage? There should not be a minimum volume for storage, since a small volume of cord blood could be used in regenerative medicine, or 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. The minimum volume eligible for processing at Progenics is 10 mL (without anticoagulant). Since a small volume of cord blood could be used in regenerative medicine or could be expanded in the future, all cord blood is processed and stored when the volume is 10 mL or higher; however, if the volume is less than 20 mL before processing, parents will obtain a 50% discount on the cord blood storage fees. If the volume is less than 10 mL, then according to the mother’s request in the consent and agreement, Progenics will either process the cord blood, or will contact the mother to provide information on the sample. The final decision to process the cord blood will then be made by the mother. |
Follow the instructions given to you at the time of registration for transporting the collected cord blood to Progenics:
If your delivery hospital is located in the Greater Toronto Area (GTA), it is free to have your baby’s cord blood picked up at the bedside either by Progenics’ staff (North York General Hospital) or by Air Logistics (medical courier).
For locations outside the GTA, Progenics will pay a portion of the courier fees in order to make it more affordable for our clients to choose the highest level of courier service (next flight out) provided by Air Logistics.
Air Logistics provides three levels of courier service for clients to choose from. The highest level of service (next flight out) is strongly recommended in order to maintain the quality of the cord blood.
You will be notified by our office as soon as the cord blood is received and/or processed.
Cord blood should be processed within 48 hours after collection; however, the shorter the period before processing begins, the higher the quality of the cord blood. Since we assist our clients by making it affordable for them to choose the highest level of courier service, the average time between collection and processing of cord blood is 15.5 hours.
Note: 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 (≤24-36 hours).
At Progenics, the average time between collection and processing is 15.5 hours, which could be the shortest time frame in this field. To achieve this, Progenics offers FREE cord blood pick up in the Greater Toronto Area (GTA) and pays a PORTION of the fee for shipping cord blood from other areas, in order to make it more affordable for our clients to choose next flight out courier service provided by the medical courier. If a sample of cord blood is received later than 48 hours from the time of collection, then the viability will be assessed to determine whether the cord blood is still eligible for processing and storage.
Processing is a procedure involving extraction of nucleated cells by removing red blood cells and excess plasma in order to save nucleated cells. Ideally, all nucleated cells are extracted and all red blood cells are removed during processing, but this is impossible to achieve, so cord blood banks try to extract nucleated cells and remove as many red blood cells as possible. It is very challenging to extract more nucleated cells without compromising the quality by contaminating the total nucleated cells with a high concentration of red blood cells. Because of this, it is critical to use a superior processing technique. Results will differ significantly between cord blood banks due to differences in both the processing technique and the cord blood bank’s experience.
Note: Cord blood consists of mainly red blood cells, nucleated cells and plasma. At birth, cord blood is collected in a collection bag which usually contains 35 millilitres (mL) of anticoagulant to prevent clotting. At Progenics, the average volume of cord blood collected is 72 mL, so the total volume of cord blood with anticoagulant is over 100 mL. Volume reduction is performed to reduce both the amount of space required for storage and the required volume of DMSO (10%, v/v), which is a cryoprotectant that protects cells from injury during freezing, but which is toxic to patients. The standard volume of the cord blood after processing is approximately 22 mL. 10% DMSO is then added to make a final volume of 25 mL, which is saved for future transplantation.
The yield of total nucleated cells (TNC) is the number of TNC extracted from processing, expressed using the following formula:
Note: The number of total nucleated cells (TNC) is the most important indicator of a successful transplant. Since 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.
Based on information that has been published in scientific and medical journals, the average yield of TNC is less than 80%.
With the superior double stem cell extraction processing technique developed by Dr. H. Yang et al, the average yield of total nucleated cells at Progenics is over 97.7% based on ALL samples stored at Progenics (>10,000 samples).
The concentration of red blood cells is expressed by the hematocrit.
A study demonstrated that a high concentration of red blood cells can damage up to 1/3 of cord blood stem cells during cryopreservation (freezing). 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."
In addition, if there are too many red blood cells, then it could be necessary to wash the sample before transplantation, which can lead to a loss of 10-30% of cells during washing.
It has been proven by an important clinical study for the first time that red blood cell contamination in the final product impairs the efficacy of autologous bone marrow mononuclear cell therapy (Assmus B. et al. Journal of the American college of cardiology (2010) 55:1385-9).
With Progenics' processing procedure, the average hematocrit is 8.5% (for cord blood with a volume >20 mL), which is superior to other processing procedures that achieve a hematocrit of 24% (published).
Absolutely not. In fact, the viability after processing is slightly higher (Solves et al., Cytotherapy (2009) Vol. 11, No. 8, 1101-1107) and (Yang H et al. Factors affecting banking quality of umbilical cord blood for transplantation. Transfusion (2011) Vol.51, 284-292).
Note: Without proof that can be compared to our results, any statement made by other bank(s) about our double processing technique is non-professional and misleading.
Progenics will send you a “Certificate of Cryopreservation” which reports the processed date, volume collected, yield (recovery rate) of total nucleated cells (%) and percentage of contaminating red blood cells (hematocrit) in the banked cord blood component.
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If the cord blood volume is ≥ 10 mL (minimum processing volume), you will receive a Certificate of Cryopreservation after Progenics has obtained all of the results for both the maternal viral marker blood tests and the cord blood microbiological tests. We will contact you as per your request in the consent and agreement you completed at registration, and provide you with information about the cord blood if the volume is below 10 mL. If the volume of collected cord blood is < 20 mL, then you will receive a 50% discount on the annual storage fee for 20 years. The certificate with processing results and the quality guarantee confirms the successful processing and storage of your child's cord blood. You should expect to receive this certificate about 4-6 weeks after the birth of your child. |
Basically, the cryopreservation procedure includes the addition of a 10% Dimethyl Sulfoxide (DMSO) solution with an optimal cooling rate 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 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. |
At Progenics processed cord blood is stored in the vapor phase in a liquid nitrogen vapor phase 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 are 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 (gas) phase or liquid phase. The critical temperature for storing cord blood is -135°C. If a sample reaches a temperature higher than -135°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 that the power supply is equipped with a backup generator. At Progenics, processed cord blood is cryopreserved using a controlled-rate freezer and is then stored in a liquid nitrogen freezer (vapor phase), where the temperature is -180°C or lower and is monitored 24 hours. A backup liquid nitrogen freezer is available at all times in case of an emergency. |
Cord blood stem cells have demonstrated the ability to be stored for over 20 plus years in liquid nitrogen without significant damage (Broxmeyer He et al. Proc Natl Acad Sci USA 2003; 100: 645-650, Blood online March 10, 2011). 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 a temperature below -130°C. The temperature in the storage freezers is maintained simply by liquid nitrogen and not by electricity, so samples are reliably kept below the critical temperature. |
Banking quality = Number of TNC extracted from processing and expressed as a percentage (%)
Processing is a procedure for reducing volume by removing red blood cells and excess plasma to leave behind the nucleated cells in the component of cord blood that will be banked for future transplantation.
Note: The most important consideration for parents who have their babies’ cord blood banked is to have more cells saved by preventing cell loss during processing. Cord blood banks cannot bank more cells than the number of cells collected at birth from the baby by the physician, but cord blood banks CAN make a difference in terms of the number of cells extracted, expressed as a percentage (%). Cord blood banks can make a significant difference by preventing a loss of cells during processing.
Feasibility and Accuracy!
Almost no private cord blood banks (banks that store cord blood for families) are able to provide the recovery rate (yield) of CD34+ cells (CD34+ is a stem cell marker) to each family, since it is not practical to perform a CD34+ cell count both before and after processing due to the higher cost and the waste of valuable cells for the test (reduction in the number of cells available for transplantation). More importantly, the stem cell count (CD34+ cells) has not been standardized yet and results vary from 3-5 times between different laboratories, so it cannot be used as an indicator of banking quality. It is useful, however, to assess cells before and after cryopreservation, so nearly all cord blood banks perform the CD34+ count. Progenics performs a CD34+ count and viability assessment on all cord blood samples after they are processed.
Note: Total nucleated cells (TNC) are the most reliable indicator for a successful transplant (Moroff G et al. Transplantation and Cellular Engineering (46) 507-515, 2006). CD34+ cells are nucleated cells and both of them are significantly correlated.
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.
No, it is best to keep your stored cord blood in the bank since transferring it from one bank to another by air 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 cord blood bank’s storage facility and it will be 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 nearly anywhere in the world.
If a member of 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 centre.
You have four options for registering with Progenics.
For clients outside the Greater Toronto Area, please obtain shipping information before you begin your registration. Clients within the GTA will receive free cord blood pick up at their bedside.
Progenics has very flexible payment options to accommodate most clients who may have different financial situations. We do not normally offer an 18 year storage option, but storage fees are guaranteed not to increase for 20 years.
In order to provide you with the highest banking quality, we offer either free shipping of cord blood (in the GTA) or, we will assist you financially so that you can choose the highest level of courier service. The highest level of courier service should be selected so that your baby’s cord blood can be shipped to our processing lab in the shortest possible time in a temperature-controlled environment.
Please see Schedule of fees
We highly recommend that our clients register at least TWO months before their expected due date. In certain circumstances you can still 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.
Note: Progenics has banked cord blood from babies born THREE months before the expected due date, so try to register early to avoid missing this once-in-a-lifetime opportunity.
Note: In case you forget to bring your collection kit to the hospital, please ask your nurse or physician to use an emergency kit if your delivery hospital is North York General Hospital. For other hospitals, please call Air Logistics at 1-866-882-8865 to request that they deliver a collection kit to you if they can. On short notice, it is not guaranteed that they will be able to ship a collection kit to you in time before you give birth and a fee could be charged.
Suitability of a cord blood donor (so that the cord blood can be banked at either a public bank or for the family) is assessed based on the standards of AABB and the criteria of Health Canada. Meeting the standards of the AABB has been verified through inspection by the AABB. Suitability of cord blood donors is strictly screened by our designated registered nurse. Testing for infectious disease markers in maternal blood strictly adheres to AABB standards, so the cord blood stored at Progenics is safe and can be used anywhere in the world. The tests include:
Yes, visit our secure website and simply click on “My Account” and follow the instructions to make your payments or update your information.
