In order to understand quality better, ask yourself the following questions and read the answers provided.

1.	Why should I have my baby’s cord blood saved? It is stored for future use to treat life-threatening diseases for my baby or a family member.
2.	Why is the quality of banking important? The suitability of cord blood for transplantation and the success of a transplant are mainly determined by the quality of the banked cord blood.
3.	Who will determine if the banked cord blood is good enough for transplantation to my baby or a family member? When a patient needs a cord blood stem cell transplant, the transplant physician (specialist) will decide whether to use the banked cord blood.
4.	What are the most critical questions that a physician will ask the cord blood bank in order to make his or her decision? The physician will ask the cord blood bank for the cell dose of total nucleated cells (TNC) in the stored cord blood. If the patient is  the baby, the sufficient cell dose is 20 x 106 cells/kg body weight and for family members, the sufficient cell dose is 25 x 106/kg body weight. Since the number of cells in cord blood is limited, banking more cells by maximizing the extraction of TNCs from each cord blood sample during processing is critical.
5.	Which factors will affect the number of banked cells? No cord blood bank is able to save more than the number of cells contained in the collected cord blood; however, cord blood banks CAN lose a significant number of cells during processing (20-40%). Processing cord blood is, therefore, the most important factor contributing to banking more cells by preventing the loss of valuable cells during processing. Different processing techniques result in significantly different outcomes.  READ MORE Quality of banking from different processing methods: With the table below, you can compare for yourself Progenics’ results Yang H et al. Cytotherapy  11: 18 (2009) abstract  (the full paper will be published in a scientific journal shortly) with results that have been published for other processing methods (Solves et al., Cytotherapy (2009) Vol. 11, 1101-1107). The most comprehensive study published recently was performed by Dr. Solves, a worldwide leading scientist in cord blood banking. This is the first study comparing the advantages and disadvantages of different methodologies used in routine cord blood banking.     PROCESSING METHOD       HES*** (n=92) Optipress*** (n=772) AXP*** (n=490) Progenics’ Double processing**** (n=3,219) Comments Before processing Volume of cord blood (mL) 108.2mL 109.2mL 104.8mL 74mL We process all samples (regardless of volume) with the client’s consent, so the volume is smaller. Total nucleated cells (TNC) x 106 1,237 1,469 1,406 1,087 Smaller volume, therefore, fewer cells. Hct** (%) 39.4 37.6 39.1 35.2 Hct is slightly lower since the red blood cells in smaller volumes of cord blood were diluted by the anticoagulant. After processing Volume 21.2 mL 40.8mL 21.0mL 22mL Standard volume after processing is <25mL. For larger volume samples, the Optipress II cannot limit the volume to less than 25mL. TNC X 106 (based on 74mL) 930.8 (637) 1,190 (806) 1,074 (758) 1,055 (1,055) The initial volume is much different but the number of cells after processing is nearly the same. TNC recovery* 76.4% 80.5% 60% (25 mL) 76.7% 97.6% There is approximately 20% difference in TNC recovery.   Hct 24.1% 36.6% 26.2% 7.7% Concentration of red blood cells is 3-4 times less after processing. Red blood cell depletion 86.1% 63.1% 86.8% 94.3% Depletion of many more red blood cells. Viability of cells 87.9% 93.8% 89.5% 94.8% More cells were alive (viable) after processing. TNC recovery rate 6.5% <60% 1.8% <60% 4% <60% 0.04% <80% At most banks at least 30-50% of samples have less than 80% recovery of TNC.  At Progenics, cord blood banking will be free if the TNC recovery rate is less than 80%. To our knowledge, ONLY Progenics has this guarantee. ***Published by Solves et al., Cytotherapy (2009) Vol. 11, No. 8, 1101-1107) **** Yang H et al. Cytotherapy  11: 18 (2009) abstract , (Yang H et al, Transfusion 2010 in press). Notes: *The recovery rate of TNC is the most reliable indicator for comparison (not CD34+ cells since“ the lack of a standardized method for CD34+ cell quantification makes it difficult to compare results among banks”) (Cytotherapy (2009) Vol. 11, No. 8, 1101-1107) . The best processing results are a higher recovery rate of TNC and a lower concentration of red blood cells (lower Hct). **Hct is an abbreviation for hematocrit (a blood test that measures the percentage of red blood cells found in cord blood either before or after processing).
6.	Can I know the processing quality right after the cord blood is processed? Yes, but it is very challenging for cord blood banks to issue a quality certificate that contains the most important quality indicators, which include (1) recovery rate of TNC (%) (regardless of the volume of cord blood processed) and (2) concentration of red blood cells (hematocrit) (%) left in the banked cord blood. To our knowledge, Progenics is the only bank worldwide that issues this certificate.   READ MORE Almost no private cord blood banks (banks that store cord blood for families) are able to provide the recovery rate of CD34+ cells to each family, since it is not practical to perform a CD34+ count both before and after processing due to the higher cost and the waste of valuable cells for the test. 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. 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). Please do not confuse TNC with CD34+ cells from some banks. The total number of cells in the cord blood after processing cannot be compared between cord blood samples since the TNC varies significantly with the volume of cord blood processed. Indicators of processing quality are the recovery rate of TNC (the higher the better) and the hematocrit (the lower the better).

Why Is Progenics’ Double Processing Technique Necessary?

The results speak for themselves, so you can tell from the table of results that Progenics’ double processing technique is superior.

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Human umbilical cord blood stem cells have been successfully used to treat almost 80 diseases; however, their application is limited because of a low number of transplantable cells in each sample. A physician will determine if the cord blood can be used to treat a patient based on the number of cells stored per kilogram of body weight. Larger patients require more cells, and transplantation of more cells leads to better survival after the transplant and a higher chance of the patient being cured of the disease. Therefore, quality refers to the number of cells available for transplantation and higher quality means that more cells are saved from processing an equal volume of cord blood, which is collected by the mother’s physician. The number of cells obtained from an equal volume of cord blood is determined by the processing method used. Progenics’ unique double processing technique is far better than all other processing methods used at other banks. For public cord blood banks (not banks that store cord blood for families), double processing might not be necessary (higher cost), since at public banks, up to 60 or 70 % of samples are discarded for a number of reasons, including low recovery rate of transplantable cells from processing; however, for private cord blood banks (banks that store cord blood for families), nearly all samples are processed and banked for future use. Processing is, therefore, critical in order to save more cells for your family. Saving more cells (and not losing cells during processing) can only be achieved by using a superior processing technique. Different banks’ advertising materials can be confusing, though, and some banks claim quality by making statements, but do not provide any published numbers for comparison. Because the opportunity to bank a baby’s cord blood only occurs once in a lifetime, every client deserves to have scientific information in order to compare processing methods and choose a high quality bank. With the table above, you can compare for yourself Progenics’ results Yang H et al. Cytotherapy  11: 18 (2009) abstract (the full paper has been accepted and will be published in a scientific journal shortly) with results that have been published for other processing methods (Solves et al., Cytotherapy (2009) Vol. 11, No. 8, 1101-1107). The most comprehensive study published recently was performed by Dr. Solves, a worldwide leading scientist in cord blood banking. This is the first study comparing the advantages and disadvantages of different methodologies used in routine cord blood banking. Progenics processes cord blood using a modified double processing method that was developed by our Laboratory & Scientific Director. The results have been accepted for publication in Transfusion [Yang H et al. Transfusion 2010 (In press)]. It is important to understand the procedures involved in cord blood banking, also known as the cord blood transplant program.  A cord blood transplant program includes:  (1) collection (2) processing (3) cryopreservation (freezing) (4) storage in liquid nitrogen (LN2) and (5) transplantation.  We can analyze how each of these procedures affects the number of cells banked. Collection In general, a larger volume of cord blood contains more TNCs (R2=0.6); however, one of the weaknesses of cord blood is that the volume from the placenta and umbilical cord blood is limited. As a result, cord blood is mainly used to treat children and small adults. The cord blood is collected by a physician and not by the cord blood bank; therefore, the volume collected is affected by the attending physician and by the placenta or umbilical cord, but not by the cord blood bank. Processing Because the volume of cord blood is limited, it is critical to extract more cells from the collected cord blood to increase its suitability for transplantation to patients with higher body weight.  Comparison of results from processing the same volume of cord blood shows that there is a significant difference between banks in the recovery rate of cells (TNCs). There is at least a 20% difference between banks in the recovery rate of TNCs, and for some samples the difference can be up to 50%.   This leads to a significant difference in the eligibility of cord blood for transplantation, especially when the baby gets older and has a higher body weight. The recovery rate of TNCs is, therefore, an important indicator of high quality processing. The hematocrit (Hct), or concentration of contaminating red blood cells, is another important quality indicator of the processed cord blood.   A high number of red blood cells in the final product (processed cord blood) will result in a significant loss of stem cells during freezing for storage and thawing for a transplant.  Cryopreservation Some cells will die during freezing but a high concentration of red blood cells in the final product may result in a significant loss of stem cells, which will reduce the chance of having a successful transplant. Storage in a liquid nitrogen freezer Very few cells will die during storage as long as the temperature is maintained below -135°C, which is never a problem since liquid nitrogen freezers are very simple and easy to maintain.  It has been proven experimentally that cord blood can be stored for 21 years without showing significant damage when it was assessed. Transplant Cord blood may have to be washed before it is infused to the patient. Washing may be done for any of the following reasons:   Washing is the transplant centre’s policy. There are too many red blood cells. There is a larger volume of cord blood (standard volume should be about 25 mL).  If washing is done, a significant portion of cells will be lost (10-30%). In summary, out of the factors listed above, processing is the major factor affecting the number of cells available for a transplant and is the ONLY factor that the cord blood bank can control. Cord blood banking quality is, therefore, determined by: (1) a high recovery rate of TNC and (2) low contamination by red blood cells in the final product of processed cord blood.  The best cord blood banks are those that can achieve the highest recovery rate of TNC and lowest contamination by red blood cells (Hct) in the final product which is stored for future transplant to treat diseases.  To our knowledge, Progenics is the only bank that can accomplish both goals, and we prove it with our quality certificate. Our results speak for themselves, while other banks make claims about their quality but do not provide any results for comparison.