StemCyte Answers Your FAQs from "The Parents Guide to Cord Blood"

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The Parents Guide to Cord Blood

The Parents Guide to Cord Blood is an impartial website created to provide unbiased information and education about cord blood banking and medical research. The website contains a comparison table for different banks and a suggested questionnaire for parents to use when choosing a cord blood bank to store their babies' cord blood. Here is the link: http://www.parentsguidecordblood.org.

To help make your comparison process easier, we have answered all of the questions below, in addition to our regular Frequently Asked Questions section. We hope you find this useful and educational so that you can make an informed decision about cord blood banking and learn why StemCyte is unparalleled in comparison.


Cord Blood Collection Process

Will the cord blood company proactively contact the labor & delivery staff for you or are parents responsible for this?

Most hospitals do not have a system in place to track this type of information before you are a patient. Therefore, it is your responsibility to let the hospital staff know when you arrive. However, we will contact your OB with collection instructions following your enrollment with StemCyte. A StemCyte collection nurse is available to speak with your OB if he or she has any questions about these instructions. Again, when you arrive at the hospital, please inform the Labor and Delivery staff that you are saving your baby's cord blood. And, remember to bring your collection kit!

 

Do they recommend collecting cord blood before or after delivery of the placenta?

Our StemCyte collection kit allows for your doctor to choose to collect before or after delivery of the placenta. Both collection methods are acceptable and can result in high volume collections.

What collection method do they use?

We collect the cord blood with a gravity bag. We have chosen this collection method because it is a closed system which decreases the opportunity for contamination. High-volume collections can be achieved with a gravity bag if the collector is patient and follows our instructions. The volume goal for the collection should be a minimum of 75 milliliters. Many clinicians find it helpful to weigh the unit on the baby scale as it's collected. 1 milliliter is approximately equal to 1 gram of cord blood when weighed. Our empty bag weighs 67 grams.

What storage method do they use, vials or bags?

StemCyte stores our cord blood products in cryo-preservation bags. Bags decrease the opportunity for contamination, and most accrediting agencies are now requiring that cord blood stem cells be stored in bags.

What equipment is provided in the collection kit and are there any spares?

The contents of the collection kit include the cord blood bag and label, ChloraPrep swabs, multiple clamps, and a hemostat. The maternal sample collection kit includes blood tubes, alcohol prep pad, collection needle and vacutainer. Our kit also includes a C-section adaptor kit. Our materials include safety devices to protect the medical staff from needle sticks – an OSHA requirement and now also a requirement of most hospitals. Also included in the box are collection instructions, corresponding cord blood and maternal sample forms and temperature stabilizing packs.

Our validated, temperature-controlled cord blood collection shipping container meets the same high standards recommended by the FDA in their cord blood guidance draft for unrelated cord blood shipping. Having a temperature-controlled kit helps maintain the optimal temperature during transportation of your baby's unique cells. This protects your family's precious stem cells during shipping to our laboratory through all seasons and weather conditions.

The kit contains everything needed to collect cord blood, but there are no spares. Our past customers have not indicated that there was a need for 'spares'. With the exception of the collection bag, the equipment contained in our kit is also readily available on most labor and delivery units should it be necessary to have a spare.

What instruction tools are provided for the physician and delivery staff?

Collection instructions for the physician are included in the collection kit. We also post our collection instructions on our website for your physician or midwife to download should they want to view them at any point in time. Additionally, a StemCyte collection nurse is available at 1-866-389-4659 to answer any questions your physician has about the cord blood collection.

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Shipping and Handling

Is the cost of shipping included in the contract?

All shipping fees, including the return of the unit by a medical courier, are included in the contract.

If the bank uses a courier, do they provide secure chain-of custody handling?

We have selected Quick International as our medical courier due to their outstanding track record and history of providing courier services for organ transplants. Once the cord blood has been picked up, you can track the transport of your baby's cord blood from your hospital room to our lab via a secure identification system on our website. Our exceptional 24-hour phone service is manned by masters-trained social workers who are there to support you and provide an excellent level of service. All of our procedures are designed to give you confidence and assurance of the safe arrival of your baby's cord blood.

On weekends, is the laboratory staff in-house or on-call?

Currently our laboratory staff is in-house Monday through Saturday and is on-call for Sundays. Our laboratory is notified of the pickup of your baby's unit and if it is scheduled for delivery on Sunday, we ensure that there will be laboratory staff available to process your baby's cord blood.

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Laboratory Testing and Accreditation

Will you notify the parents of the time at which the cord blood arrived, and the time at which it was processed?

Yes, a StemCyte Family representative will call to notify you that the cord blood has been processed and will give you the processing date and volume of the cord blood. The record of the arrival of your cord blood unit can also be tracked through our website.

Q: What tests are performed on maternal blood?

The maternal sample is tested for infectious diseases including but not limited to: HIV, Human T-Lymphotropic Virus (HTLV), Hepatitis B and C viruses, syphilis, Cytomegalovirus (CMV)).

Do you ever reject samples on the basis of maternal tests?

Cord Blood samples may be discarded if the maternal sample test results are confirmed positive for HIV, Hepatitis B or Hepatitis C, Chagas disease, or West Nile Virus.

Do you test the cord blood collection for infectious disease markers?

At the time of processing, we do not test the cord blood for infectious disease markers. However, we do save aliquot samples for these tests in the event that the processed product is requested for transplantation and there are licensed kits available for testing. Currently there are no licensed kits to test cord blood for infectious disease markers.

Do you test the cord blood collection for contamination by bacteria, etc.?

Yes, sterility tests are performed for aerobic and anaerobic bacteria and fungi during processing of the cord blood. Other tests performed on the cord blood include complete blood count with differential, nucleated and mononucleated cell count, CD34 count, red blood type (ABO/Rh), viability assays, and other selected tests in order to evaluate the suitability of the cord blood for storage.

Do you ever reject samples that are contaminated?

Generally if the sterility testing is positive (contaminated with bacteria) we will store the cord blood but it is placed in a special quarantine tank and not stored with samples which have tested negative. Whether or not the contaminated cord blood product can be used for transplantation is dependent on the regulations established by the FDA and other accrediting bodies as well as the transplant physician.

Will you notify parents of the test results, especially the final cell count?

The final cell count and volume information are recorded on the certificate and all other laboratory results are kept on file for every processed product. Abnormal test results would include positive infectious disease results on the maternal sample. Should you or your physician desire the results of any of the other tests that have been conducted, please contact our customer service department, and we will be happy to provide them to you.

Do you maintain a separate "quarantine tank" for the long-term storage of blood that has failed one or more tests, or is the blood stored together regardless of testing status?

Yes, we have a quarantine tank where all infectious disease positive and sterility positive products are stored in vapor phase dewars. Storing in vapor phase prevents any cross contamination of the cord blood collections.

Do you HLA type the sample?

We do not HLA type your baby's cord blood at the time of processing. We do save aliquot samples that may be typed if the cord blood product is requested for transplant.

Some states license cord blood banks (NJ, NY): Do they operate in those states?

StemCyte accepts cord blood collected in all states, including those that require licenses. We can do so because our U.S. laboratory, is also licensed for the four states currently requiring special licenses: California, Maryland, New Jersey and New York.

By which organizations are they accredited?

StemCyte's laboratory has numerous accreditations, licenses and certifications. In 2006, our laboratory met the criteria for cord blood collection, processing, testing, banking, selection and release of products, becoming the first and only laboratory in the world accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) for autologous (personal use) donations. Additionally, StemCyte is a National Marrow Donor Program (NMDP) member bank, is accredited by the AABB (formerly the American Association of Blood Banks, and has a California state Biologics license. We are also licensed in the four states currently requiring licenses which are California, Maryland, New Jersey and New York.

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Processing

Is the blood stored whole or processed to separate mononuclear cells (MNC)?

StemCyte's cord blood processing protocol, called the StemCyte Stem Cell Optimization Process, stores plasma-depleted whole blood. Our processes includes over 400 laboratory and quality control procedures and we are able to recover more of the total nucleated cells [1] than any other processing method. Our public bank has supplied over 700 products using this process and the success rate/efficacy of our products has been outstanding.

[1] Chow, Robert; Nademanee, Auayporn; Rosenthal, Joseph; Karanes, Chatchada; Jaing, Tang-Her; Graham, Michael L.; Tsukahara, Elsa; Wang, Brian; Gjertson, David; Tan, Patrick; Forman, Stephen; Petz, Lawrence D.: Analysis of Hematopoietic Cell Transplants Using Plasma-Depleted Cord Blood Products That Are Not Red Blood Cell Reduced. Biology of Blood and Marrow Transplantation 13:1246-1357 (2007).

What is the minimum volume they will accept for storage?

Our minimum volume for banking families is 8 cc.

Is the blood stored as a single unit or several samples?

StemCyte stores our cord blood products in single bags. We have learned from our experience in providing over 700 products for transplantation to over 150 transplant hospitals worldwide that transplant physicians prefer to use bags. The bag contains multiple additional small aliquots which can be individually thawed and used for additional testing, typing and possible cell expansion.

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Storage Facility

Do you operate your own storage facility or lease space in one? In what type of facility is the bank located?

StemCyte operates our own storage facility, which is located in the same single-story commercial building with our laboratory and office headquarters.

What is the geographic location of the storage facility?

Our office headquarters, laboratory and storage facility are all located in Covina, California, near Los Angeles. Our building is a single story, structurally sound facility. The liquid nitrogen storage tanks used to hold cord blood are built of heavy, industrial grade stainless steel and are virtually indestructible. They weigh approximately 3,000 pounds and are on wheels. The tanks do not need electrical power and can maintain their temperature for 20 days without any human intervention.

Are the cord blood samples in a separate freezer or mixed with other medical samples?

We only process and freeze umbilical cord blood; therefore, our freezers only contain cord blood.

What type of freezer do they use?

We use vapor phase liquid nitrogen tanks with a dewar system, which is a thermal insulation system that maintains freezing temperatures for extended periods of time without the need for refrigeration. The vapor phase helps to prevent any potential cross-contamination.

Do they freeze in liquid nitrogen or vapor nitrogen?

StemCyte freezes the cord blood using a controlled rate freezer and the vapor phase of liquid nitrogen.

What type of records do parents receive after storage?

Parents will receive a cord blood certificate with information including the collection volume , date processed, cord blood identification number and total nucleated cell (TNC) count of the baby's cord blood unit.

Does the contract state that the storage fee is fixed, or may it increase later?

Yes, the storage fee is fixed for the duration of the contract (until the child turns 18).

Does the bank reserve the right, in the contract, to change storage facilities?

We own and operate our storage facility on site with our lab, but we do reserve the right to change storage facilities.

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Company Stability

Is the family cord blood bank a publicly-held or privately-held company?

StemCyte, Inc. is a privately held company with several divisions. Our U.S. laboratory, is the processing, storage and release laboratory for both our public cord blood products and our family bank products. StemCyte is dedicated to bringing the quality and efficacy of a public bank's processing to families who want to save their own baby's stem cells for their family. In order to do this, we use the same lab for both public and private collections for processing and storage. All collections that come through our lab receive the same 400 standard operating procedures and quality controls to ensure that every final product is processed to our rigorous standards. After all, one day these cells may be needed to save the life of someone you love.

Is your company affiliated with a hospital or research institution?

StemCyte, Inc. is not formally affiliated with a specific hospital or research institution but, on a daily basis, our laboratory and transplant coordination team works with the leading transplant hospitals and their physicians all over the world. Additionally, as noted below, we are involved in a number of research collaborations with other institutions. As StemCyte has now supplied cord blood stem cell products to over 150 of the leading transplant hospitals around the world, we have the opportunity to continue to collaborate with the top experts in cord blood and stem cell research. We do, also, collect donated cord blood units at ten hospitals across the United States. Additionally, StemCyte is a sponsor of the Annual International Umbilical Cord Blood Transplantation Symposium, which was held for the eighth consecutive year in San Francisco in June 2010. To learn more, please visit the Cord Blood Forum web site: www.cordbloodforum.org or go directly to the symposium web site: www.cordbloodsymposium.org.

Is your company involved in bio-technology research and development?

In terms of research, StemCyte, Inc. has established stem cell therapy research collaborations with a number of institutions, most notably the City of Hope and the Keck Center at Rutgers University. In addition, StemCyte is collaborating with a number of the leading research hospitals in using cord blood stem cells to treat and cure a number of genetic and autoimmune diseases including thalassemia and spinal cord injuries.

What other medical services does your company perform?

StemCyte operates one of the largest public cord blood bank networks in the world. Also, our outstanding HLA laboratory is ASHI-accredited and performs HLA tissue typing services.

How long has your company been banking cord blood?

Our company was founded in 1997, has been banking cord blood since 2000, and many of our employees have extensive prior experience in blood and cord blood banking, at places like the University of California Los Angeles (UCLA) and the City of Hope Medical Center. The family banking division of StemCyte began in 2003.

Who directs the day-to-day business of the company?

StemCyte's management team consists of our CEO, CFO, two Medical Directors who work exclusively for StemCyte, Laboratory Director, Compliance Officer, and our highly trained staff of laboratory technicians. Please visit stemcyte.com for detailed information about our company's management team.

How many privately banked cord blood samples do you currently hold?

StemCyte stores its publicly donated (unrelated) and privately cord blood center in Arcadia, CA and the Taiwan National Cord Blood Center in Taipei, Taiwan. We currently store a combined total of more than 30,000 products in our cord blood bank facilities.

How many transplants have been performed with your cord blood samples?

StemCyte, Inc.'s cord blood laboratories in the U.S. and Taiwan have contributed more than 1,700 cord blood products for transplants to over 286 transplant hospitals worldwide, treating the majority of the diseases approved for treatment with cord blood.

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Consumer Rights

In the event that the storage company went bankrupt, what would happen to the cord blood samples?

The protocol in our Service Agreement states that if StemCyte is unable to provide continued storage, we will contact another storage facility to transfer the cord blood. Given the strategic importance of our large donor bank (one of the two largest in the world), with a potential transplant market value of over $400 million, combined with the rapidly growing value of our family cord blood bank, we are confident that all of our cord blood products would be well protected, if any kind of business structure transition were ever necessary.

If the cord blood is lost or severely delayed during shipping, what liability does the company accept?

Unfortunately, because we cannot control what happens during shipment, we cannot be held liable for damages or delays incurred during shipping. However, we do contract with Quick International, a reputable medical courier that provides quality shipping and delivery.

If the storage fee is not paid, what happens to the cord blood?

StemCyte Family will make every attempt to contact the client regarding payment of annual storage fees. In the event of non-payment of storage fees, StemCyte assumes rights to the cord blood unit, and the continued storage of the unit is at StemCyte's discretion.

Does the company take any portion of the cord blood for proprietary purposes, or does 100% go into storage?

100% of the cord blood goes into storage for your family. Your baby's product is exclusively reserved for your family's future use.

Does the storage company reserve any rights in the contract? Example: reserves the right to change the storage facility?

We do not have a separate storage contract. StemCyte owns and operates our own storage facility, and all rights, including the right to change storage facilities, are outlined in our Service Agreement as part of your enrollment.

Does the contract protect the privacy of the parents health information, as stipulated by the Health Insurance Portability & Accountability Act (HIPAA regulations)?

While we are not required to abide by HIPAA regulations because we are not a healthcare provider, StemCyte does maintain a very strict privacy policy to safeguard you and your family's personal information and confidentiality.

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Price Protection

Is the enrollment fee charged once per family, or for each birth?

The enrollment fee is charged for each birth, however, we do offer special discounts for repeat customers and for families having multiple births.

At what week of gestation are late enrollment fees imposed, and how much are they?

We do not charge late enrollment fees. However, there are additional charges for overnight shipping of the kit and for mothers enrolling on the day of onset of labor. A rush fee of $300 may be incurred for same-day enrollment (enrolling and receiving your collection kit on the same day, which is not available in all areas).

How do they charge for cord blood samples from multiple births?

We offer discounts for multiple births. Please call 1-866-389-4659 for more information.

If the cord blood collection is small or contaminated, are we offered any refunds?

In the event the collection is not performed or the cord blood unit is not processed due to low volume, you will be charged $150.00. In the event that the cord blood unit is collected and processed, but is not acceptable for storage (i.e. Hepatitis B or C, HIV, WNV), a processing fee will be applied.

Is the storage fee guaranteed fixed?

Yes, the storage fee is fixed for the duration of the contract (until the child turns 18).

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