Client suitability assessment

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:

• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibody (anti-HBc)
• Hepatitis C virus antibody (anti-HCV)
• HIV-1 and HIV-2 antibody (anti-HIV-1 and anti-HIV-2)
• HTLV-I and HTLV-II antibody (anti-HTLV-I and anti-HTLV-II)
• Serologic test for syphilis
• Nucleic acid amplification testing (NAT) for HIV-1 and HCV
• NAT for West Nile Virus (WNV)
• Cytomegalovirus (CMV)

Easy to follow cord blood collection procedure

To ensure that the attending physician or midwife collects more cord blood at the birth of your baby, Progenics provides a simple and easy to follow collection procedure. The average collection volume of cord blood at Progenics is 75 mLs and less than 1% of the collected cord blood samples are discarded because of low volume and cell content in the sample. The larger the volume of cord blood, the better, since the volume is significantly correlated with the number of total nucleated cells and stem cells (CD34+ cells).

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Unique processing technique

Processing is the most critical step in obtaining a high quality cord blood sample for future transplant. The quality is determined by whether the number of cells banked is enough when a transplant is needed.  Therefore, saving more cells throughout processing from the same volume of cord blood, is an indicator of a better cord blood bank. An increased yield of cells from processing  is determined by the following: Higher yield (recovery rate) of Total Nucleated Cells (TNC) Consistency of yield (recovery rate) of TNC Lower concentration of red blood cells, quantified by hematocrit

Progenics uses the modified unique double processing technique developed by our Laboratory and Scientific Director, Dr. H. Yang (Yang H. et al. Bone marrow transplantation (2001) 27;457-461).   The quality is significantly better than other techniques (compared with published information). If you would like to know the differences between the processing methods that other banks use  (Optipress and AXP) and double processing (the method used at Progenics), please contact our office. We will provide you with the most recently published information from scientific journals.

1. 20% higher yield (recovery rate) of total nucleated cells The number of total nucleated cells (TNC) in cord blood is limited compared with bone marrow. The suitability of cord blood for a transplant and the success of a transplant (engraftment) are mainly indicated by the dose of TNC, therefore, a higher yield (recovery rate) of TNC from processing indicates that the chance of having a successful transplant will be higher. As this figure shows, compared to other cord blood banks that have published their data, the yield (recovery rate) of TNC obtained at Progenics is significantly higher.

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2. Consistency of the yield (recovery rate) of TNC The figure shows that the yield (recovery rate) of TNC is consistent and only 2/6519 samples of processed cord blood were below 80% (but very close to 80%.) Your chance of getting a yield (recovery rate) below 80% is almost 0 (<0.1%). In addition, unlike most other banks, the yield (recovery rate) of TNC did not decrease with increasing cord blood volume. You should have confidence that Progenics will achieve a higher yield of TNC and will save more cells from the same volume of cord blood. Because Progenics saves more cells, there is a greater chance that the banked cord blood can be used for transplantation to heavier patients.

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3. The chance of obtaining different yields (recovery rate) of total nucleated cells The figure shows that if you bank with Progenics you will have a 99.9% chance of getting over 80% yield (recovery rate) of total nucleated cells (TNC), a 99.6% chance of getting over 85%, a 98.4% chance of getting over 90% and an 96% chance of getting over 95%. Compare these results to other banks, where only 60% of cord blood samples have over 80% yield (recovery rate) of TNC, and less than 10% have over 95% and it is clearly evident that your chance of obtaining a higher yield (recovery rate) is very high at Progenics.

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4. Concentration of red blood cells (hematocrit) The figure shows that the hematocrits were significantly different between Progenics and other banks (based on published information). The concentration of red blood cells is quantified by hematocrit (Hct), which is the proportion of cord blood volume that is occupied by red blood cells. It is very difficult to remove red blood cells without compensating by decreasing the yield (recovery rate) of TNC. In the presence of a very high concentration of red blood cells, up to 31% of stem cells will be injured during the cryopreservation process.  Therefore, a good processing method should result in a higher TNC and a lower concentration of red blood cells as shown in the figure on the right.

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Read More

Progenics uses a unique Double Processing Technique developed by Dr. H Yang (Yang H. et al. Bone Marrow Transplantation (2001) 27; 457-461). In his study, Pentaspan was demonstrated as an effective reagent to be used to process cord blood instead of the widely used Hespan. Pentaspan is a lower molecular weight reagent and is cleared from the circulation relatively rapidly after cord blood is transplanted. Compared to most other cord blood banks (published information) the technique increases the yield by about 20% more nucleated cells , so that the successful transplant rate of cord blood will be significantly higher. The yield (recovery rate) indicates the percentage of nucleated cells recovered from processing. Hematocrit shows the percentage of red blood cells left in the processed cord blood, which is saved for future transplant. Hematocrit plays a key role in the quality of banked cord blood since a higher hematocrit (0.36) could damage up to 31% of cord blood stem cells after cryopreservation (Solves et al, Transfusion 45:867-873(2005). However, this is overlooked by most cord blood banks. The yield (recovery rate) indicates how successful the processing procedure was in recovering nucleated cells, and the total number of nucleated cells is a reliable predictor for a successful transplant. Therefore, it is important to combine the recovery, hematocrit and total nucleated cells left from processing to predict transplant success. The average volume of cord blood collected is 75 mL. The average yield of total nucleated cells from our processing procedure is 97.6% with only 0.1% of our samples with less than 80% yield. It is critical to get more cells from processing, and to obtain a higher yield (recovery rate) of nucleated cells, since the number of total nucleated cells is the most important indicator of a successful transplant. Progenics' yield (recovery rate) is about 20% higher than most cord blood banks (published information). The average removal of red blood cells during our processing is 94% and the hematocrit is 0.08. The average stored number of nucleated cells is over 1000 x 106 /unit.

Cryopreservation

Dr. Yang has systematically investigated the cryopreservation of cord blood (Yang H et al. Cytotherapy (2001) 3:377-386) (Yang et al. Cryobiology (2005)51:165-175.). He has gained comprehensive experience in the high quality cryopreservation of your baby's cord blood and is capable of dealing with any unexpected interruptions during cryopreservation. This is one of the many reasons you should feel more secure when your baby's cord blood is cryopreserved at Progenics.

Assurance of secure long term storage

Cord blood is stored in a two compartment Pall freezing bag that is over-wrapped with another cryobag and stored in a MVE -190ºC vapor (gas) phase freezer, to avoid any cross-contamination from infectious diseases.
The freezers containing cord blood are stored in a secure storage facility for  long term storage. The freezers are powered with a back-up power generator to prevent power failure and the temperatures are monitored 24 hours a day. Of the three most commonly used sizes of freezers, Progenics uses the smallest size. If there is ever an emergency, the smaller size of the freezer will allow us to transfer the cord blood samples from a dysfunctional freezer to a back-up freezer while avoiding extra cell damage due to warming. There is always a back-up liquid nitrogen freezer available where we can transfer the contents of a dysfunctional freezer immediately.

Validated quality assessment

All cord blood samples are evaluated for viability after processing with a flow cytometer to ensure the cord blood cells are still viable after processing. Enumeration of stem cells (CD34⁺ cells) is also performed for each cord blood sample so that the quality of your baby's cord blood can be determined. Quality is important for the storage of cord blood and quality assessment should be performed after storage in a liquid nitrogen freezer after a certain period. However, your baby's cord blood cannot be tested regularly. Progenics has cryopreserved some cord blood samples from voluntary donors as quality control specimens, which are tested when necessary to judge the storage quality of your baby's cord blood. Quality assessment from stored cord blood samples is affected by many factors , including the calculation itself. Progenics uses assessment assays which are validated by Dr. Yang et al (3-5), to ensure that the quality assessment is reliable.