Technical & Science Questions

Can cord blood be stored for longer than 20 years? Companies have only been storing cord blood for the last 20-25 years. There is no evidence that it cannot be stored

indefinitely at liquid nitrogen temperatures (-196 degrees), nor is there evidence that it degrades over time. Research

conducted by one of the foremost experts on cord blood stem cells shows that after 23.5 years of storage, there was

no degradation in the cord blood samples. After 20 years of storage with Americord you can pay $120 per year or

prepay for another 20 years of storage. What cord blood processing methods does Americord’s laboratory use? Cord blood stem cells are manually separated by trained technicians following a modified “Rubinstein method” with the chemical Hespan. The lab prefers this method, because the entire process can be performed in a "closed" system (a sterile blood bag transfer set), greatly reducing the chances of external contamination while processing. How are stem cells from cord tissue processed? The cells are extracted and isolated from the cord tissue, tested to ensure viability and then preserved in vapor nitrogen tanks. How are stem cells from cord tissue and placenta tissue stored? Stem cells from cord tissue, placenta tissue, and cord blood each have their own individual cassettes and are stored separately for individual use. Does Americord store cord blood stem cells in bags or vials? Americord uses specialized cryo-bags, not vials for storage. The older vial-based method increases the potential of

seepage of liquid nitrogen in and out of the screw-top lids of the vials. Additionally, vials are not a ‘closed system’,

meaning cells are unnecessarily exposed to contaminants during processing. The cord blood storage cryo-bag

container is encased in an outer casing, cooled slowly and temporarily stored in a quarantine freezer, then moved to

a long-term freezer. The freezer uses vapor phase (not liquid) of liquid nitrogen to ensure sterility. Long-term storage

tanks are MVE 1500 series auto-fill vapor phase containers that are monitored and connected 24/7 to a 9,000 gallon

bulk tank and liquid nitrogen delivery system. How is cord blood stored at Americord’s laboratory? Cord samples are stored in the Pall 25 mL dual compartmentalized cryo bag, with three attached integral segments plus a separate 2 mL segments for future HLA typing. So you can test the samples or take out part of the cord blood segments without thawing the whole sample. What is Americord’s minimum threshold for storing cord blood in terms of milliliters and cell count? As of August 31, 2011, Americord’s average cord blood sample size for our entire inventory was 92.5 ml. However, it is possible that the amount collected from your baby could be less than the average. If the collection volume or cell

count is below a certain threshold, best practices indicate that we call you to see if you still want to store the sample,

since using today’s technology, it is unlikely that you would be able to use it for medical treatment. Americord uses the following criteria for notifying the client: Below 50 milliliters (industry standard none to 30 ml), or Below 150 million cells (industry standard 100 million) If the cord blood collection is smaller than the ideal amount, should I save it anyhow? Some clients opt to save even a small cord blood sample since future technology might enable the use of these cells or possibly the expansion of them. Several of our competitors store the collections regardless of these measurements without consideration of these factors, which really isn’t in the best

interest of the client. If the yield is below par and the client decides not to store the sample, Americord does not charge any fee. Does Americord use Heparin in its cord blood collection bags? Americord does not use Heparin in our cord blood collection bags. Heparin, which acts as an anticoagulant, preventing the formation and extension of blood clots, is not approved by the FDA for cord blood collections. Americord’s FDA-approved cord blood collection bag uses an anti-coagulant called Citrate Phosphate Dextrose (CPD). CPD is approved by the FDA for cord blood collection. Is Heparin good or bad? Heparin, which acts as an anticoagulant, preventing the formation and extension of blood clots, has been the subject of much conversation by two cord blood companies: Viacord and Cord Blood Registry (CBR). Heparin is not approved by the FDA for cord blood collections. Viacord uses Heparin-free cord blood bags, claiming that doing so maximizes collection volume and minimizes

contamination. Cord Blood Registry (CBR) claims that their use of dry heparin anticoagulant improves their ability to

“recover every stem cell possible for your child, regardless of the collection volume.” To support their claim, CBR cites a study done in 1996 by Dr. Robert Dracker, who at the time was ViaCord’s Medical Director. What does the most current research say about Heparin vs. CPD? The following studies indicate that Citrate Phosphate Dextrose (CPD) is better suited than Heparin for use in cord blood bags:

Heparin lacks the preservative needed to maintain viability of cells. (U.S. Dept of Health and Human Services, October, 2009)

CPD is less toxic to stem cells than Heparin (Joanne Kurtzberg, 2003)

Heparin’s effectiveness breaks down after 12 hours. (A.V. Hoffbrand, Daniel Catvosky, Edward G.D. Tuddenham, 2005)

Heparin negatively impacts accuracy of HLA typing. (Eliane Gluckman, Pablo Rubenstein, et al. 2000) Are there different kinds of FDA-approved cord blood collection bags? Yes. Some FDA-approved sterile exterior cord blood collection bags can only be used for vaginal births. Only one type of FDA-approved sterile exterior cord blood collection bag has been approved for ALL births, including C-sections. That bag, which Americord uses, is manufactured by Pall Corporation. It is more expensive than the others, but we feel it is worth the expense. Cord blood bags that are FDA-approved for vaginal births may be adaptable for use in a Cesarean section delivery, however the process of attaching the necessary additional parts (including a tube clamp and a needle guard) is inconvenient for the doctor and may increase the risk of contamination of the surgical area. Why does Americord use the only FDA-approved cord blood collection bag approved for ALL births? Americord uses the only sterile exterior cord blood collection bag that has been approved by the FDA for ALL births so that our clients are covered in the event that they have a Cesarean section delivery (whether planned or emergency). In a Cesarean section delivery, our use of this bag eliminates the need for your doctor to attach sterile extension sets or additional parts.