Frequently Asked Questions and Clear Answers

Family_pic_for_site

What are the uses and functions of stem cells?

A: If a patient receives chemotherapy or undergoes radiation treatment, all cells are damaged, including mature normal cells, stem cells and abnormal cells. Stem cell transplants are performed to provide new stem cells from a healthy donor to replace the defective ones. At least 80 diseases have been treated with stem cells. These include cancers (leukemias, lymphomas, myelomas), blood disorders (thalassemias, sickle cell anemia, Fanconi’s anemia), immune deficiency diseases, genetic diseases and other diseases.

Stem cells:

  • Can actively divide and produce new blood cells within 2-6 weeks and will stimulate regeneration of the blood components in the bone marrow damaged by very high doses of chemotherapy and/or radiation.
  • Can correct diseases in which the marrow is diseased or does not function properly (e.g., immune deficiency, aplastic anemia, red cell aplasia, white cell disorders).
  • Correct enzyme deficiencies in children with inherited or inborn errors of metabolism.
  • Produce other types of cells that gradually travel to the brain, liver, and other organs.

 

What are possible uses of cord blood stem cells in the future?

A: There is a lot of existing and promising research on the horizon using cord blood stem cells to treat AIDS, Alzheimer's disease, diabetes, heart disease, liver disease, muscular dystrophy, Parkinson's disease, spinal cord injury and stroke.

StemCyte is involved in collaborative research using stem cells treating some of these diseases, with a primary focus on using cord blood stem cells to treat spinal cord injury through tissue regeneration.

What is graft vs. host disease (GVHD)?

A: Graft vs. host disease (GVHD) is a serious, life-threatening complication of stem cell transplants. It occurs when the transplanted stem cells attack the patient's cells. Cord blood stem cells have been clinically shown to reduce the risk of GVHD and, when it should occur, it is less severe.

Why would a family choose to bank their baby's cord blood?

Families want the reassurance that, should their child ever need a transplant, the source of stem cells will be a perfect match. In addition, families with a history of diseases treatable with stem cells know there is a much higher probability that they will need stem cell transplant in the future.
Additionally, families with an ethnic minority background or families with children of mixed ethnicity may have specific interest in cord blood banking.

Unfortunately, current bone marrow registries are predominantly made up of donors of Caucasian descent. This makes it far more difficult for ethnic minorities to find a match should a stem cell transplant be needed. This is one of the main reasons that StemCyte was originally created--to build an ethnically diverse, public cord blood bank to fill the huge void that exists in the worldwide bone marrow registries for ethnic minorities.

Will another child or family member be able to use the cord blood?

With cord blood transplants, a sibling has the best chance of being a perfect match (about 1 in 4). Parents and other family members have less of a chance of matching a cord blood unit (about 1 in 10), though a perfect match is not necessary in cord blood transplantation.

If I’m adopting, does the cord blood banking process change?

A: There is no change in the enrollment process except that it is desirable for the birth mother to complete a medical/genetic history and submit a blood sample for infectious disease testing. Private banking may be more important than ever because if the adoption is of a child whose biologic parents and/or siblings are often unavailable and unknown because the greatest opportunity for a match is not available. Please call StemCyte for exact instructions.

What if I have a family member who needs my baby's cord blood now?

StemCyte is one of the only private cord blood banks in the industry that has a full time HLA tissue typing lab on site to establish whether the cord blood is a match. Matching should be initiated through a physician who would be considering a transplant.

Should I bank cord blood for each of my children?

There is only a 1 in 4 chance a child will match a sibling. Therefore, it makes sense to save cord blood stem cells from each child to increase the probability of being a match for a family member who may require a stem cell transplant.

What is cord blood?

Cord blood is the blood contained in the placental blood vessels and umbilical cord, which connects an unborn baby to the mother's womb. Cord blood contains hematopoietic progenitor cells. At birth, cord blood can be collected (or "recovered") from the umbilical cord.

What are hematopoietic progenitor cells?

Hematopoietic progenitor cells (HPCs) are blood-forming stem cells. HPCs are found in bone marrow, peripheral blood, and cord blood. These types of stem cells are routinely used to treat patients with cancers such as leukemia or lymphoma, and other disorders of the blood and immune systems.

How are patients and donated cord blood units “matched” so that a unit of cord blood can be used for a patient’s transplant?

Human leukocyte antigen (HLA) typing is used to match patients and donors for cord blood transplants. HLAs are proteins found on most cells in the body. A person’s immune system uses these proteins as markers to recognize which cells belong in their body and which do not. A close match between the patient’s and the donor's HLA markers can reduce the risk that the patient’s immune cells will attack the donor's cells, or that the donor's immune cells will attack the patient’s body after the transplant.

How are HPCs from cord blood different than HPCs from other sources?

There is evidence that cord blood HPCs may not require as exact a match as HPCs from bone marrow or the bloodstream because the antigens in cord blood are less mature. This suggests that transplants involving compatible HPCs from cord blood may be less likely to cause adverse reactions because the donor’s cells are less likely to see the patient’s cells as foreign bodies and attack them.

What are the options for cord blood banking?

Cord blood can be donated to a public cord blood bank, where it will be stored for potential future use by anyone who may need it. Alternatively, parents may arrange for the cord blood to be stored in a private cord bank, for potential use if it is later needed for treatment of the child from whom it was recovered, or for use in first- or second-degree relatives. Information on cord blood donation options may be found on the Health Resources and Services Administration (HRSA) web site.

You may also wish to consult your health care provider about the options.

How does FDA regulate cord blood stored for personal or family use?

Cord blood stored for personal use and for use in first- or second-degree relatives that also meets other criteria in FDA’s regulations does not require approval before use. Private cord banks must still comply with other FDA requirements, including establishment registration and listing, donor screening and testing for infectious diseases (except when used for the original donor), reporting and labeling requirements, and compliance with current good tissue practice regulations.

How does FDA regulate cord blood intended for use in patients unrelated to the donor (i.e., cord blood stored in public banks)?

Cord blood stored for potential future use by a patient unrelated to the donor meets the definition of “drug” under the Food, Drug & Cosmetic Act and “biological product” under Section 351 of the Public Health Service Act. Cord blood in this category must meet additional requirements and be licensed under a biologics license application (BLA), or subject to an investigational new drug application (IND) before use.

Are there any FDA approved uses for cord blood?

Cord blood can be used in hematopoietic stem cell transplantation procedures in patients with some disorders affecting the hematopoietic (blood forming) system. For example, cord blood transplants have been used to treat patients with certain blood cancers and some inherited metabolic and immune system disorders.

If a cord blood bank is registered with FDA, does that mean that the cord bank is FDA approved?

Establishments that perform any of the manufacturing steps for cord blood must register with FDA and list their products and each of the manufacturing steps they perform. Registration with FDA doesn't mean a firm is "endorsed" by the agency, it simply means the firm has notified FDA that it is performing one or more manufacturing steps.

FDA’s website has a searchable database2 that includes information on registered cord blood banks.

Does FDA inspect facilities that store cord blood?

Yes. Registered establishments are subject to FDA inspection to ensure they are complying with the regulations. The inspections of private banks are designed to ensure prevention of infectious disease transmission.

Where can I get more information about donating my baby's cord blood?

To make your baby's cord blood available for use by anyone who needs a cord blood transplant, you may donate it to a public cord blood bank. Information on donating cord blood to a public cord blood bank is also found on the HRSA web site.

Where can I get more information about banking my baby's cord blood?

To make your baby's cord blood available for use by the child from whom it was recovered, or for use in first- or second-degree relatives, you may bank it with a private cord blood bank. Information on banking cord blood with a private cord blood bank is also found on the HRSA web site.

For some diseases, such as genetically heritable diseases, in the event that your child would need treatment, it is possible that the cord blood would not be recommended for such use.

Where can I get more information about FDA's regulations?

Information about the regulation of human cells, tissues, and cellular and tissue based products including cord blood is available on FDA's web site.

end

Collection

How, when and where is the umbilical cord blood obtained?

The umbilical cord blood is collected after the baby has been delivered and the umbilical cord has been clamped and cut. The cord blood can be obtained before or after the delivery of the placenta (afterbirth). In the post placental method (ex-utero method), trained personnel will collect the umbilical cord blood after the afterbirth has been taken out of the mother's womb. In the preplacental method (in-utero method), the physician/obstetrician collects the cord blood in the delivery unit while the placenta is still in the womb.

Using sterile techniques, your healthcare professional inserts a sterile needle into the umbilical vein to allow drainage of the blood by gravity into a sterile bag containing anticoagulant. The entire collection process averages five to ten minutes. Your baby's collected unit will be transported to our processing center for further processing, testing, and storage.

Regardless of collection method, all options are safe for both the mother and baby.

Will any healthcare provider know how to perform the collection and who is likely to perform the cord blood collection? Does StemCyte train my physician, midwife or labor delivery staff?

Your healthcare provider will perform the collection. This may be your doctor or midwife. StemCyte will provide collection instructions upon request. StemCyte does send a fax to your delivery doctor and detailed instructions are provided in the collection kit. Also, a medical staff representative will be available 24 hours a day if there are questions during the collection process.

 

Does the hospital need to provide any materials or information for the collection?

No. All of the necessary materials for collecting and shipping the cord blood will be contained in the collection kit that is sent to you. The hospital will not need to provide any additional materials.

Is the amount of blood collected important?

Yes. The greater the amount of blood collected, the more stem cells will be available for transplantation. This becomes particularly important if the onset of disease requiring a stem cell transplant occurs when the child has grown.

What if I have a C-section?

No problem. Stemcyte's New collection kit is sterile so the cord blood can still be collected by your healthcare provider. Since cord blood is collected after the baby is born and the umbilical cord has been clamped and cut, with a C-section, the cord blood can be collected after the C-section and after the baby is born.

 

Can the collection take place after the cord stops pulsating?

Some mothers, obstetricians, midwives and doulas prefer to wait until the cord stops pulsating before clamping and cutting it. The cord blood collection process should not interfere with normal birthing procedures, and it may begin after the cord stops pulsating.

 

end faq

Shipping and Handling

How is my baby’s cord blood sent to your laboratory?

We are unique among family banks in that heavily insulated transport containers are used that have been lab tested to maintain an optimum temperature during shipment under all weather conditions throughout the United States. Many family banks require the parent to arrange for pick up and transportation, we take care of all of the logistics of getting the transport container from your hospital bedside to the processing laboratory.

The couriers we use are highly experienced in the transport of umbilical cord blood and will ensure the most safe and efficient transportation to our laboratory.

How long will the cord blood stem cells remain viable in the kit after collection?

Collected cord blood must be processed within 48 hours in order to store the highest quality product for transplantation.

Should the cord blood be kept at room temperature before shipping?

Yes. From collection time until processing time, the cord blood should be kept at room temperature. The packs contained in the shipping box will help ensure temperature maintenance even during extreme weather conditions.

Will I receive confirmation that my baby’s cord blood arrives at your laboratory?

Yes. We will give you a courtesy call to confirm receipt of your cord blood shipment.

What if I live outside the United States?

StemCyte collects cord blood in the US, Canada Puerto Rico and Mexico. Please call us regarding collections outside the United States.

Will my healthcare provider charge a fee for the collection?

Some healthcare providers may charge a fee for collecting cord blood.

How long will the umbilical cord blood be in storage?

Cord blood units are stored at very low temperatures in a vapor phase of liquid nitrogen. Studies have revealed that cryopreserved cord blood cells have been stored for up to 20 years and have remained viable. It is believed that cord blood stem cells may be stored indefinitely.

How do I know my baby’s cord blood is stored safely and properly?

Cord blood units are bar code labeled and repeatedly checked for proper identification. The frozen cord blood is stored in locked, stainless steel liquid nitrogen freezers in our state-of-the-art facility. The temperature of the storage freezers is computer-monitored at all times and any deviation from the proper temperature is immediately brought to the attention of laboratory staff. The freezers have double locks and require two individuals for accessing the cord blood units. Our quality program and method for assuring the identity of the cord blood ensures that your baby's cord blood will be accurately identified.

 

Is there a cost to retrieve the sample?

No.

How do we retrieve the sample if ever needed?

If someone in your family becomes ill with a disease that is treatable with cord blood stem cells, the attending transplant physician will contact us for technical information about the unit. If the physician decides to proceed with a transplant using that unit, he or she will send us a request for the shipment of the unit to the transplant center.

stop

StemCyte Difference

How is StemCyte different?

Because StemCyte offers family banking at a leading public donor bank, expectant parents get the peace of mind that comes from a number of important and unique benefits.

  • A superior track record of providing unsurpassed quality cord blood units for transplantation. StemCyte's public bank has provided more units for stem cell transplants than all other family cord blood banks combined (over 1700 transplants and growing each month).

  • StemCyte's Medical Director Da Lawrence Petz MD, PhD edited the world's first stem cell transplantation textbook, one of the most respected series of blood bank textbooks, and was the former Chairman of Medicine at City of Hope National Medical Center.

  • The StemCyte Medical and Scientific Advisory Board includes the Director of the Bone Marrow Transplant Program of the MD Anderson Cancer Center, and the Director of the Bone Marrow Transplant Program of the City of Hope National Medical Center.

  • A serious commitment to charging a fair price for our service that will enable more parents to consider this important medical choice.

  • A dedication to make this important decision and process clearer and easier for busy expectant parents by providing straight talk and honest answers to questions as well as friendly customer service.

 

How do you save so many stem cells?

StemCyte's Cell Optimization process is designed to maximize cell recovery throughout collection, processing and storage. Our kits are temperature controlled to ensure that a consistent temperature is maintained during shipping. Our proprietary Plasma Depletion Processing saves more cells than red cell reduction processing that is used by other cord blood banks.
This translates directly into an unsurpassed engraftment rate post-transplantation. This high transplant engraftment rate is the result of the unexcelled post-processing cell yield of StemCyte's proprietary modified whole blood processing technology, which also produces consistently high viable post-thaw cell recovery of the products.

  • Because of the efficient procedure and meticulous care that we take between the addition of DMSO to freezing and using our validated thawing procedure, we are able to achieve post-thaw viability in the range of 90%.

Is the StemCyte laboratory accredited?

Though StemCyte was founded in 1997, it has already achieved an enviable record of successful transplant engraftment. Our stem cell transplant products have been used all over the world, including the U.S., Brazil, Taiwan, Hong Kong, Singapore, Malaysia, Israel, Australia, and Spain. Many of the products result in white blood cell engraftment within twenty days. More importantly, patients as large as 220 pounds (100 kg) have been successfully transplanted using cord blood from StemCyte.

  • Outstanding engraftment rates with all cases being with non-related patients, including many adults, according to National Marrow Donor Program (NMDP) official data.

  • World's first successful multi-cord non-myeloablative cord blood transplant performed by Professor Patrick Tan of Singapore General Hospital was provided by StemCyte International Cord Blood Center.

  • We believe that our outstanding transplant engraftment rate and kinetics are due to our outstanding post-processing cell dosage and post-thaw viability.

  • StemCyte cord blood stem cell collections have been used by over 278 leading transplant centers around the world such as Fred Hutchinson, Harvard-Dana Farber, Harvard-Massachusetts General Hospital, Columbia, UCLA, UCSF, Singapore General, National Taiwan University, Children's Hospital of Philadelphia, and University of Michigan, to name just a few.

 

Is the company financially stable and how long has it been in operation?

StemCyte was incorporated in 1997 and has grown to be one of the largest public cord blood banks in the world. In 2003, StemCyte made private banking available to provide cord blood services to families. This unique blend of public and private cord blood banking will result in a financially strong company which will be able to cost-effectively support both transplant centers and family clients.

How soon do I have to decide to enroll with StemCyte for the collection of my baby's cord blood?

Although the decision can be made as late as two weeks before delivery, it is best to enroll by week 30. We also provide a various discounts and no-interest payment plans, which are subject to change, so it's best to enroll early and avoid over-night shipping fees. This Early Bird Program not only saves you money but also ensures that there will be time for adequate preparation with your doctor.

How do I enroll?

You may request an enrollment package from StemCyte online, by mail, by telephone, or by E-mail. You can start by clicking the 'Enroll Now' button in the upper right hand corner of this Web page.

What are the banking fees?

The total cost for enrollment, collection kit, collection, shipping to our laboratory, processing, and storage for the first year is $2,300, with various discounts and payment plans available.

How do you ensure confidentiality?

We take every possible precaution to maintain confidentiality of your records. We will not release the medical information unless authorized by you or as required by law. Information from this program may be given to the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), or the California Department of Public Health (DPH).

Medical records, which identify you and your child, and the consent form signed by you, may be looked at and/or copied for regulatory purposes by these agencies. Because of the new Health Information Portability Accountability Act (HIPPA), these parties must protect your health information. Data and results of this program may be presented at meetings or in publications. However, you or your child's identity will not be disclosed in those presentations.

What is included in the collection kit?

The collection kit is sent in the shipping container. The box has a temperature stabilizing pack, Shipping Log, maternal peripheral blood sample collection kit, and the umbilical cord blood collection kit. The maternal kit consists of an absorbent sleeve, 4 peripheral blood collection tubes, disinfectant, collection tube holder, collection needle with safety device, adhesive bandage, and a Maternal Blood Sample & Health History Update Form. The cord blood collection kit contains a sterile collection bag, disinfectant, label for the bag, and the Collection & Delivery form kit.

Are there federal regulations for cord blood banking?

The Food and Drug Administration (FDA) has proposed regulations for tissue banking, including cord blood banking, however, many of the processes are regulated under blood banking and tissue regulations.

When did cord blood transplantation start?

Through international collaboration, the first human cord blood transplant was performed in France on October 6, 1988. The cord blood of a female sibling was transplanted to a 5 year-old boy with Fanconi Anemia. The stem cells engrafted, and no graft vs. host disease (GVHD) occurred.

Is there a minimum amount of cord blood that needs to be collected in order to process and store?

StemCyte requires a minimum of 10 cc of cord blood for processing and storage.

What if, for medical reasons, the my healthcare professional is not able to collect the baby's cord blood?

As always, the primary concern is for the health and well being of the baby and mother. If for any reason there is any concern, the doctor may decide not to collect the cord blood.