Superior Banking Procedures

Cord blood banking includes: Client suitability assessment Select Cord Blood Donors using strict criteria Cord blood collection Collect more cord blood using easy to follow cord blood collection instructions Transportation of collected cord blood Efficient Transportation System including faster courier service with temperature control and monitoring Processing Higher recovery rate of stem cells and lower concentration of red blood cells after processing Cryopreservation Freezing protocol proven with successful transplants of cord blood Storage Triple Safety policy to secure your baby's cord blood for future use Quality assessment Using systematically validated post-thaw viability assessment assays

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:

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 larger the volume of cord blood collected the better. The average collection volume of cord blood at Progenics is 78 mLs and less than 1% of the collected cord blood samples were discarded because of low volume and cell content in the sample.

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Efficient Transportation system for collected cord blood

It is critical to ship cord blood  for processing safely and in a timely fashion.
Three factors during transportation are the most critical for quality assurance of the cord blood.

1. Temperature
   Progenics monitors the temperature of cord blood samples during transportation using a programmed thermometer to make sure the cord blood samples are shipped within safe temperatures.
2. Duration
   Cord blood can even be processed up to 48 hours after collection but the shorter the better. Up to date, Progenics has processed cord blood within 13 hours after collection.
3. Medical Courier
   To ensure that your baby's cord blood is transported under conditions necessary to maintain its quality, Progenics only uses medical couriers experienced in transporting cord blood.

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 from processing from the same volume of cord blood is an  indicator of a better cord blood bank. The yield of more cells from processing  is determined by the following: Higher recovery rate of Total Nucleated Cells (TNC) Smaller range of recovery rate of TNC Lower concentration of red blood cells quantified by hematocrit

 Progenics uses the 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).

1. Recovery rate of TNC

The number of TNC in cord blood is limited compared with bone marrow and the dose of TNC is the most important indicator of a successful transplant (engraftment) of cord blood since the TNC count has been approved as the most reliable measure. Therefore, a higher recovery rate of TNC from processing indicates the chance of a successful transplant will be higher. As this figure shows, the recovery rate of TNC was significantly higher than most other cord blood banks based on published data.

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2. Smaller range of recovery rate of TNC

I. Consistency of recovery rate

The figure shows that the recovery rate of TNC is consistent and only 2/3400 samples of processed cord blood were below 80% (but very close to 80%.) Your chance of getting a recovery rate below 80% is almost 0 (<0.1%). In addition, unlike most other banks, the recovery rate of TNC did not decrease with increasing cord blood volume.

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II. The chance of getting recovery rates of TNC

The figure shows that if you bank with Progenics you will have a 99.9% chance of getting over 80% recovery of TNC, a 99.6% chance of getting over 85%, a 98.4% chance of getting over 90% and an 80.8% chance of getting over 95%. To compare with most other banks with a chance of only 60% of getting over 80%, you know your chance of obtaining a higher recovery rate is very high at Progenics.

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3. 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 recovery rate of TNC. In the presence of a 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.

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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 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 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 78 mL. The average yield of total nucleated cells from our processing procedure is 96.8% 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 recovery rate of nucleated cells, since the number of total nucleated cells is the most important indicator of a successful transplant. Progenics' 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.

Validated computer-operated controlled-rate freezing

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. Read more ...

assurance of secure long term Storage

The two compartment Pall freezing bag is over-wrapped with another cryobag and stored in a MVE -190ºC vapor 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.  In addition, there is always a back-up liquid nitrogen freezer where we can transfer all contents from a dysfunctional freezer instantly.

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VAlidated Quality assessment

All cord blood samples will be evaluated for viability after processing with a flow cytometer to ensure that cord blood cells are viable after processing. Enumeration of stem cells (CD34+ cells) will be performed for each cord blood sample so you will be informed of the quality of your baby's cord blood. 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 what the storage quality of your baby's cord blood is without touching it. 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.

In conclusion, you can compare our data with published information from other cord blood banks so you will know only Progenics can store more cells based on a reliable banking process.