01. How soon should I register with Progenics?
We 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 Progenics’ office for further details regarding the registration process.
Progenics has banked cord blood from babies born THREE months before the expected due date. Early registration will ensure taking advantage of this once-in-a-lifetime opportunity.
02. What should I do after registering with Progenics?
- Pick up a collection kit at Progenics or, if you prefer, a collection kit will be shipped to your home or work once your online registration, over the phone, emailed, mailed or faxed registration is approved. It takes 1-2 business days to courier the kit to you. Normally there is no charge for shipping a kit.
- If a kit is shipped to you, open the outer brown cardboard box and take out either the white collection kit or blue collection kit. The type of kit you receive depends on how the kit will be shipped back to Progenics after the cord blood is collected.
- After you open the brown cardboard box, take out the envelope and read the "Instructions for Parents". Keep the cord blood collection kit (either the white box or blue case) at room temperature and do not freeze or overheat the kit.
- 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). Remember to take the kit out of your luggage if you have placed it inside.
- Except for clients at North York General Hospital, call the designated medical courrier when you are admitted to the hospital so that they can have a courier on standby to pick up the cord blood.
If you forget to bring your collection kit to the hospital, please ask your nurse or physician to use an emergency kit (only if your delivery hospital is North York General Hospital or hospitals which have our emergency supplies). For other hospitals in where emergency supplies are not available, please call the designated medical courrier 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.
CORD BLOOD SHIPPING
03. How will the cord blood be shipped to Progenics and how much will it cost for shipping?
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 the designated medical courrier (specialized cord blood transportation 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 the designated medical courrier.
04. 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 processed.
CORD BLOOD COLLECTION
05. What is cord blood?
After a baby is delivered, the umbilical cord is clamped and cut close to the baby's "belly-button". Fetal blood, known as "cord blood", is left in the remaining umbilical cord that is still attached to the placenta. This "left over" blood is traditionally discarded with the placenta as biological waste. However, scientists have discovered that cord blood is very rich in special kinds 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.
06. What are Hematopoietic Stem Cells (HSC)?
HSCs are pluripotent cells that have a capacity for self-renewal. They continuously replicate and some of them differentiate into the components of the blood and immune system. 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 that are routinely used for medical treatments are:
- Bone marrow
- Peripheral (circulating) blood
- Cord blood
07. What tests will be performed to assess the suitability of my baby’s cord blood for banking?
Suitability of a cord blood donor 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:
CORD BLOOD PROCESSING
10. When should cord blood be processed after collection?
Cord blood should be processed within 48 hours after collection. However, the faster 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 17 hours.
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 a shorter storage time of ≤ 24 – 36 hours before processing is preferred.
At Progenics, the average time between collection and processing is 17 hours, which could be the shortest time frame in this field. If a sample of cord blood is received after 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.
11. How is cord blood processed?
Volume reduction is often used as the routine processing approach for cord blood. The cord blood volume is reduced by removing red blood cells and excess plasma in order to obtain a final product that contains the remaining nucleated cells which are then cryopreserved and stored.
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 since this is impossible to achieve, cord blood banks will attempt to extract nucleated cells by removing as many red blood cells and excess plasma as possible to yield a final component with a standardized volume of about 22 millilitres(mL). It is very challenging to extract more nucleated cells without compromising the quality and at the same time avoiding the contamination of the nucleated cells due to 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.
It is important for you to know-how many of those cells the cord blood bank is able to harvest for every 100 cells collected by your doctor.
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 is toxic to patients. The standard volume of cord blood after processing is approximately 22 mL. 10% DMSO is then added to make a final volume of 25 mL.
12. What is the yield of total nucleated cells?
The yield of total nucleated cells (TNC) is the percentage of nucleated cells which were extracted from the original cord blood sample (i.e. the number of cells extracted from every 100 cells that was available for extraction). It is expressed using the following formula:
The number of total nucleated cells (TNC) is the most important indicator of a successful transplant. The disadvantage of cord blood, when compared with bone marrow, is its lower number of cells due to its smaller volume. Thus if more cells are lost during processing, then it decreases the potential of success in larger patients.
Based on information that was published in scientific and medical journals, the average yield of TNC is about 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 98% based on ALL samples stored at Progenics (≈18,000 samples).
13. Why is the yield of total nucleated cells from processing important, but not the yield of stem cells?
Feasibility and Accuracy!
Almost no private cord blood bank (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 significantly 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: The number of total nucleated cells (TNC) is 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 are significantly correlated.
14. Does double stem cell extraction processing injure more cells than the conventional processing technique?
Absolutely not. In fact, the viability of nucleated cells after processing is slightly higher (5% higher) (Solves et al., Cytotherapy (2009) Vol. 11, No. 8, 1101-1107), (Yang H et al. Factors affecting banking quality of umbilical cord blood for transplantation. Transfusion (2011) Vol.51, 284-292) and (Pope B. et al Transfusion (2012)). Nearly all Stem cells (CD34+ cells) survive processing (99.43%).
Without proof that can be compared to our results, any statement made by other banks about our double processing technique is unprofessional and misleading.
15. How do I know if the cord blood has been successfully processed?
At Progenics, the success of processing is based on the yield of TNC at 85% or higher. Our standard of successful processing cannot be matched by any other banks since their average yield of TNC was about 80%. Moreover, about 50% cord blood samples processed by other banks could not meet our successful processing standard.
Progenics will send you a “Certificate of Cryopreservation” which reports the processed date, volume collected, yield (recovery rate) of total nucleated cells (%) and the number of total nucleated cells in the banked cord blood component. If the yield of TNC from processing of your baby’s cord blood is lower than 85%, you will receive free banking including 20 years of free storage (over $3,000 in value).
If the cord blood volume is ≥ 10 mL (minimum processing volume), you will receive the 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. If the cord blood volume is below 10 mL, as per your request in the consent and agreement you completed at registration, we will either proceed with processing regardless of the volume or contact you and provide you with information about the cord blood prior to processing it. A 50% discount on annual storage fee for 20 years is honored for all cord blood samples that is < 20 mL.
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.
16. How is cord blood cryopreserved?
Basically, the cryopreservation procedure includes the addition of a 10% Dimethyl Sulfoxide(DMSO) solution with an optimal cooling rate using a controlled-rate freezer.
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.
STORAGE OF CORD BLOOD
17. How is cord blood stored?
At Progenics, processed cord blood is stored in the vapor phase in a liquid nitrogen vapor phase freezer, where the temperature is ≤-180°C.
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 -150°C. If a sample reaches a temperature higher than -150°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 be 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.
18. How long can cord blood be stored?
Cord blood stem cells have demonstrated the ability to be stored for over 20 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.
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.
19. How do I retrieve the cord blood when I need it for treatment?
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.
20. Should I transfer my baby's stored cord blood if I move?
No, it is best to keep your stored cord blood in the same storage facility since transferring it from one bank to another by air poses the risk of losing the sample to a variety of potential accidents during transportation. Therefore, it is better to keep the cord blood unit at its initial storage facility and then have it transferred directly to the transplant facility 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.
21. 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 focused on improvement of banking cord blood.
CORD BLOOD TRANSPLANT
22. 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.
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 treatments, 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 of the specific types of cells in the blood and immune system. For some diseases, stem cell transplant is the standard treatment. For some diseases they are the only therapy, and in some cases 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 40,000 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).
23. 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 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 are more tolerant than bone marrow stem cells.
24. What kinds of diseases can be treated with cord blood stem cells?
Numerous types of diseases have been successfully treated with stem cells. These include cancers (leukemia, 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.
25. What is the chance of using cord blood?
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 opportunities for using cord blood are expected to increase with advances in research and improvements in transplantation. With reference to the information published by Center For International Blood & Marrow Transplant Research (CIBMTR), the number of patients using their own stem cells (autologous treatment) for adult bone marrow or peripheral blood stem cell transplants, is about 3 times higher than those who received donated stem cells (allogeneic treatment). This suggests that there is a higher probability for individuals to use their own cord blood stem cells when they are older.
26. How much cord blood is needed for a transplant?
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); so 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.
27. Should I bank cord blood for each of my children?
Since there is a 25-30% chance that a child will match a sibling perfectly, it makes sense to save cord blood stem cells from each child to increase the probability of matching a family member who may develop a disease requiring stem cell therapy. Moreover, the additional cord blood samples can be used for patients whose treatments require two cord blood samples.
28. Can a successful transplant of cord blood be guaranteed?
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, is whether the number of cells banked is sufficient for the transplant when needed. Thus if there are not enough cells for a transplant, then how can the transplant be successful?
The success of a transplant DOES correlate with the cell dose of total nucleated cells (TNC) infused into 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, extracting a higher cell dose during processing should increase the success of a transplant, given that the conditions of patients are similar.
29. What does a cord blood bank do?
There are basically 8 steps that all cord blood banks perform in order to bank cord blood stem cells, but only one of these steps are key to determining final banking quality. It is this particular step in processing which makes each cord blood bank different. For other steps, cord blood banks generally employ very similar techniques.
Screen Mothers To Ensure They Meet The Criteria For Cord Blood Banking
All banks screen expectant mothers according to standards set by Health Canada and FDA. If the bank is accredited by the AABB (American Association of Blood Banks) or FACT (Foundation for the Accreditation of Cellular Therapy), then the bank will also screen mothers according to AABB or FACT Standards, which are based on FDA regulations. There is no significant difference between AABB and/or FACT accredited cord blood banks in regards to screening.
Obtaining accreditation is a basic requirement for all cord blood banks. However, obtaining accreditation from more than one organization does not necessarily contribute to banking quality. This is because the banking quality of a cord blood unit is dependent upon the processing techiniques and technology of the cord blood bank.
Provide A Collection Kit
A cord blood collection kit is provided to the attending physician for collection of cord blood at birth. The difference between cord blood banks is that they provide different cord blood collection bags in their kits. Some banks provide collection bags that are sterile both inside and outside (critical for C-sections) while other banks provide collection bags that are only sterile on the inside. In addition, some banks charge a fee to deliver the collection kit to their clients and some do not.
To prevent contamination, especially during C-sections, it is crucial to use a collection bag that is sterile both inside and outside.
Provide Information On Transportation Of Cord Blood
The cost for transportation of cord blood varies significantly depending on the nature of the courier (temperature controlled medical vs regular) and the level of courier service (next flight out vs next day for cities located far from the cord blood bank). Both these factors of time between collection and processing, and temperature during shipping, hugely influence the final quality of the banked sample. To optimize shipping conditions, the cord blood bank will provide information to clients on shipping and assist clients financially so that they can choose the highest level of courier service.
A good cord blood bank should process cord blood within the shortest possible time after collection.
Provide A Collection Procedure To Attending Physician
Cord blood is collected at birth by the attending physician. The cord blood bank should provide explicit instructions for physicians unfamiliar with the collection procedure.
The cord blood bank cannot control the collection of cord blood by the physician.
Processing is the most important factor that affects banking quality, since superior processing quality can increase the suitability of the cord blood for a transplant and can increase the chance of having a successful transplant. The most important quality indicator is the yield of total nucleated cells (TNC) since stem cells are not significantly damaged during cryopreservation (freezing).
A good cord blood bank should provide results for quality indicators in writing and should not make statements about quality without showing results. Ask the cord blood bank to show you their numbers!
There is no significant difference between cord blood banks today, since nearly all cord blood banks store cord blood stem cells in freezing bags instead of in freezing vials. There is, however, a significant difference between freezing bags. Freezing bags that have two compartments are preferred so that the cord blood can be used for up to two transplants in the future. Freezing bags should also have overwrap in order to prevent cross contamination.
Freezing bags with two compartments and overwrap are preferred. However, storage of two freezing bags is not preferred, as two bags contain twice the volume of cryoprotectant (cryoprotectant is necessary for the cryopreservation of cells but is toxic to the patient).
Arrange Transportation Of Cryopreserved (Frozen) Cord Blood
Cord blood stem cells will be transported by the cord blood bank to the transplant centre. Transportation should be the same for all cord blood banks, except some charge a fee and some do not.
The cost for shipping cord blood to the transplant centre is a factor to consider, but it is not related to the quality of banking.
Follow Up After Transplantation
Transplantation will be performed at transplant centres (hospitals) by transplant physicians, NOT by cord blood banks.The important information is not the number of cord blood samples that the bank has released for transplantation, but the engraftment (the process of transplanted stem cells reproducing new cells) of neutrophils (white blood cells) and platelets (indicators of a successful transplant), as well as how long the engraftment lasts and how long the patient survives after transplant.
The number of samples released from a cord blood bank for transplantation is related to the cord blood bank’s history and the number of samples banked, and is not related to banking quality (unless more important information is provided from publications in scientific and medical journals).
30. Why is AABB accreditation important?
It is essential for a cord blood bank to be accredited by the AABB (American Association of Blood Banks) or FACT (Foundation for the Accreditation of Cellular Therapy), since an accredited cord blood bank has to meet standards set out by the accreditation organization. However, in terms of quality, it is redundant for a bank to have accreditations by both since they are very similar and the additional accreditation does not necessarily indicate a higher quality of banking. The cord blood bank should focus on the quality of banking instead of spending time and resources on obtaining additional accreditation.
The AABB accreditation program is accredited by the International Society for Quality in Health Care (ISQua). 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 be accredited by the AABB or FACT and in addition, should save more cells by preventing cell loss during processing. Progenics has been AABB accredited since 2005, just one year after being in operation.
31. Can I make payments and change my information online?
Yes, visit our secure website and simply click on “My Account” and follow the instructions to make your payments or update your information.