Frequently Asked Questions (FAQs)
Cord Blood FAQs
What are Stem Cells?
In other words, stem cells are blank slates. They have the potential to become any of the tissues and organs found in our bodies. For example, stem cells can be turned into specific differentiated cells types, like muscle cells for the heart, bone cells, or nerve cells. Research is showing that stem cells may one day act as a super repair kit for the body-generating healthy tissues to grow replacement organs or even cure cancer.
What is umbilical cord blood (UCB)?
What are the advantages of umbilical cord blood?
Why should I collect and store my baby's cord blood?
Who should strongly consider cord blood banking services?
- Families with a higher predisposition to certain diseases, i.e. blood disorders, immunodeficiency diseases and cancers.
- Couples who suffer from infertility as the chance of conceiving again is unknown, there is less of a chance a future sibling’s cord blood stem cells could be used in the event a transplant is needed.
- Those adopting an unborn child, because the contact with the child’s birth parents will be lost, it’s a good idea to store the cord blood of the adoptive child.
- Children with a mixed ethnic background have a lower chance of finding a human leukocyte antigens (HLA) tissue matched sample.
- Minor ethnic groups. It may be very difficult to find a Human Leukocyte Antigens (HLA) matched sample among minor ethnic groups due to their low population.
Is there any risk to me or my child?
Can you collect cord blood if the delivery is by C-Section?
Using HealthBanks’s FDA approved collection bag is necessary to maintain a sterile operating room environment. Furthermore, the anticoagulant used in our sterile collection bag is Heparin-free. Heparin, used in some cord blood collection kits, is not approved by the FDA; and it adversely affects total nuclear cell count and CD34 contents of the cord blood, which are primary indicators of graft potency.
Heparin breaks down after 48 hours.* HealthBanks has chosen to use the FDA and NDA approved anticoagulant Citrate Phosphate Dextrose Solution** (CPD), a cell protector, also recommended by the Department of Health and Human Services, Center for Biologics Evaluation and Research, Guidance for Industry. *** CPD nourishes cells and prevents clotting for 35 days.
CPD preserves stem cell metabolism, allowing the cells to maintain their integrity between the time of collection to processing and freezing as well as result in a significantly higher total nuclear cell count (TNC) before and after cord blood processing.**
CPD preserves stem cell metabolism, allowing the cells to maintain their integrity between the time of collection to processing and freezing as well as result in a significantly higher total nuclear cell count (TNC) before and after cord blood processing.**
**HealthBanks’s collection bag containing CPD is FDA NDA approved and CE marked under the Medical Devices Directive for the collection of placental/umbilical cord blood.
*** During collection of cord blood, we recommend that you use an appropriate closed, sterile container sealed in a manner that prevents cell loss and contamination. We recommend that you use only citrate-based anticoagulants.” U.S. Dept of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Guidance for Industry – Minimally Maninpulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hemapoietic Reconstitution for Specified Indications, October 2009
After banking my first child's cord blood, is it necessary to bank my second child's?
With twins, is it necessary to store both babies’ cord blood? And what is required for multiple births?
Why is it important to choose a cord blood bank close to my home?
What is the process for a cord blood collection for an adopted baby?
The possibility of finding a compatible cord blood sample is higher than that of bone marrow, should we donate our cord blood to a public cord blood bank?
If the baby has an inherited genetic disorder, can his/her cord blood still be used in the future?
How long can cord blood be stored?
According to the Guidelines for Collection, Processing and Storage of Cord Blood Stem Cells as published by the New York State Department of Health:
There is no evidence at present that cord blood stem cells stored at minus 196 degrees Celsius (in liquid nitrogen) in an undisturbed manner lose either in vitro-determined viability or biological activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen.” No such validation supports the long-term storage of stem cells in traditional vapor nitrogen tanks.”
There is no evidence at present that cord blood stem cells stored at minus 196 degrees Celsius (in liquid nitrogen) in an undisturbed manner lose either in vitro-determined viability or biological activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen.” No such validation supports the long-term storage of stem cells in traditional vapor nitrogen tanks.”
In a study performed by Hal E. Broxmeyer (2011), cord blood stored in liquid phase nitrogen (LN2) and left undisturbed has been shown to retain its therapeutic capabilities for 21.5 years. HealthBanks utilizes the BioArchive System® for cryopreservation and storage of cord blood. The BioArchive System® is a computer-controlled, robotic liquid nitrogen cryopreservation and storage system that provides the only means to duplicate the conditions that were used in this study.
How and why do you freeze stem cells from room temperature to -196C?
It is unbearable to hold an ice-cube in the hand for a few minutes, so imagine what damages will be caused when directly plunging stem cells into -196°C liquid nitrogen. Therefore freezing stem cells to -196°C must go through a well-calibrated controlled-rate freezing process. HealthBanks uses the BioArchive System® which is the world’s leading system for cord blood stem cell freezing and storage. The BioArchive System® performs both the initial freezing and the long-term storage of the cord blood without any unnecessary human handling. The system is completely automatic and provides a report on the process providing evidence the sample was processed, frozen and stored properly.
There is no evidence at present that [cord blood stem] cells stored at minus 196 degrees Celsius (in liquid nitrogen) in an undisturbed manner lose either in vitro-determined viability or biological activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen.” No such validation shows the long-term storage of stem cells in traditional vapor nitrogen tanks.”
Does the hospital need to provide any materials for collection?
What will affect the collection volume of the cord blood?
Can cord blood be banked if the volume is low?
What is the likelihood of ever using our baby's cord blood?
HealthBanks FAQs
When should I enroll with HealthBanks?
How do I enroll with HealthBanks to save my baby's cord blood?
- We offer several methods of enrollment for your convenience. Enrollment options include:
- Phone: 1.888.379.2670
- Online: www.healthbanks.us
Upon enrollment, we will ship you your cord blood collection kit immediately.
How much does banking my baby's cord blood cost?
Your first year’s investment includes:
- A Sterile HealthBanks Collection Kit (100% inspected, FDA approved stem cell protectant, Heparin-free and convenient for cord blood collection for vaginal births and cesarean sections).
- Premium cord blood stem cell processing with the AXP®, known for the highest published cell recovery in the industry, saving more cells for your baby.
- The first year of storage within the BioArchive®, the industry’s leading liquid nitrogen cryopreservation and storage system designed specifically for the storage of stem cells.
Each subsequent year of storage is $150/year. Payment options and financing are available. We encourage you to speak with one of our representatives to learn more about The HealthBanks Difference: info@healthbanks.us/ 1.888.379.2670
What collection method does HealthBanks use?
Prior to delivery of the placenta (in rare cases after the placenta is delivered), your healthcare professional cleans an area of the umbilical cord using an antiseptic solution. A needle is then inserted into the umbilical vein for collection into a blood bag. After 2-4 minutes, the umbilical vein is emptied and the blood bag is clamped, sealed and labeled.
Importantly, HealthBanks uses the only FDA approved sterile (and Heparin free) collection bag for use in c-sections. Using this FDA approved collection bag is necessary to maintain a sterile operating room environment. Furthermore, the anticoagulant used in HealthBanks’s collection bag is Heparin-free.
HealthBanks has chosen to use the FDA and NDA approved anticoagulant Citrate Phosphate Dextrose Solution (CPD)*, a cell protector, also recommended by the Department of Health and Human Services, Center for Biologics Evaluation and Research, Guidance for Industry. **Unlike Heparin, CPD preserves stem cell metabolism, allowing the cells to maintain their integrity between the time of collection to processing, as well as result in a significantly higher total nuclear cell count (TNC) before and after cord blood processing.***
*HealthBanks’s collection bag containing CPD is FDA NDA approved and CE marked under the Medical Devices Directive for the collection of placental/umbilical cord blood. https://webcache.googleusercontent.com/search?q=cache:8lRecQyv_kIJ:www.pall.com/medical_41560.asp+CPD+is+approved+by+the+FDA+for+cord+blood+collection&cd=3&hl=en&ct=clnk&gl=us
** During collection of cord blood, we recommend that you use an appropriate closed, sterile container sealed in a manner that prevents cell loss and contamination. We recommend that you use only citrate-based anticoagulants.” U.S. Dept of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Guidance for Industry – Minimally Maninpulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hemapoietic Reconstitution for Specified Indications, October 2009
***Blood (ASH Annual Meeting Abstracts) American Society of Hematology “Cord Blood Units Collected with Liquid CPD Appear to Contain Significantly More Nucleated and CD34+ Cells Than Units Collected with Dry Heparin” Morey Kraus*,1, Karen Foster*,2, AsimenaRigas Bridges*,3 and Mark C. Walters, MD 4 2009 114: Abstract 4227 https://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/4227
How does HealthBanks process cord blood?
HealthBanks utilizes the FDA cleared AXP® system to process its cord blood. The AXP® enables HealthBanks to provide its customers with unique benefits and advantages over manual processing methods which are used by most private family banks. For example, The AXP® is an automated and functionally closed system to ensure maximum sterility. Each sample is processed individually and precisely in order to separate precious stem cells from other contents prior to storage that are known to cause complications when it comes time for transplant. Additionally, published studies show that the AXP® enables HealthBanks to achieve the highest and most consistent mononuclear cell (MNC) recoveries*–thereby ensuring that your sample is frozen and stored with as many stem cells as possible.
Source: New York Blood Center (97.9% sd 4.9%).
What method of storage does HealthBanks use?
HealthBanks utilizes the BioArchive® for cryopreservation, tracking and retrieval of its cord blood units. The BioArchive® is the industry’s leading liquid nitrogen (LN2) cryopreservation and storage system for stem cell samples. HealthBanks, along with many of the world’s leading public banks, use the BioArchive® because it offers distinct advantages over traditional systems used for cryopreservation and long term storage. Your sample will be secure and left undisturbed in liquid phase nitrogen until you need it. This is only possible with the BioArchive® because it robotically picks and places each sample individually.
Who will pick up the cord blood after collection and how is it transported to HealthBanks?
Why does HealthBanks store cord blood in liquid nitrogen (LN2) versus using vapor?
Most family banks store cord blood stem cells in traditional freezers, where entire racks with multiple cord blood units must be pulled out from storage and exposed to room temperature each time an individual cord blood unit is added or removed. Published research has shown that this can have a damaging effect on the stem cells*
Study by P. Rubenstein, MD, C. Stevens, MD (NYBC, 2007)
The importance of freezing and storing in liquid nitrogen is underscored in the Guidelines for Collection, Processing and Storage of Cord blood stem cells; Published by the New York State Department of Health:
[Stem] “Cells should be stored continuously in either mechanical freezer or liquid nitrogen tank equipped with an audible arm,” such is the case with the BioArchive system.
“There is no evidence at present that [cord blood stem] cells stored at minus 196 degrees Celsius (in liquid nitrogen) in an undisturbed manner lose either in vitro-determined viability or biological activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen.”
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What testing is performed by HealthBanks?
Will I receive confirmation that my baby's cord blood was stored successfully?
Yes. Once your baby’s cord blood has been processed, you will receive a cell analysis report that details the total volume of blood collected, cell count and cell viability of your sample. You will also receive a unique number for the exact location of your sample in our BioArchive® liquid nitrogen-based storage system. Should your baby ever need it, we are ready to provide it, wherever required.
Where are my baby's cord blood stem cells stored and how do I know they are stored safely?
HealthBanks is a single-story, structurally sound facility constructed of 6” reinforced concrete. The building also includes a police response security system, emergency power back-up system along with automatic sprinkler and alarms in place. Additionally, HealthBanks’s facility is monitored 24/7 with surveillance inside and outside of our laboratory, and access to the laboratory is restricted. What’s more is that the laboratory is monitored 24 hours a day by a centralized, computer-based environmental monitoring system. All document files are backed up by both hard and soft copies, on and off site, and all client contracts and test reports are locked in a secure, restricted access document filing room.
The stem cells will be specifically stored within the BioArchive®,the world’s only liquid nitrogen system that was designed specifically for cord blood stem cells and used by over 80 cord blood banks worldwide. The BioArchive, constructed of fire-rate materials, also prevents Transient Warming Events, or temperature fluctuations that may occur with traditional vapor nitrogen tanks whenever a sample is added or removed. Due to HealthBanks’s revolutionary BioArchive®tracking and retrieval system, your cord blood stem cell samples are secure and are left untouched and undisturbed until they are needed.
Parents can also have peace of mind that HealthBanks is FDA registered and inspected for cord blood stem cell processing and is compliant with all regulations. HealthBanks is also accredited by AABB, licensed by the State of California Department of Health, California Health and Safety Code, California Business and Professional Code and California Code of Regulations.
Rest assured, your baby’s stem cells are stored safely with HealthBanks.
Are HealthBanks's processing methods and results published?
Does HealthBanks perform research?
University of Kansas Medical Center, in a research project to develop a vaccine for HIV
Taiwan’s Industrial Technology Research Institute, in research to treat neurodegeneration, including such disorders and diseases as Parkinson’s, Alzheimer’s, multiple sclerosis, and ALS
Johns Hopkins University and Taiwan University in research to develop a HPV vaccine for the treatment of cervical cancer, and applications for the treatment of HIV, Hepatitis B, Hepatitis C, and Avian influenza
Cell Stem Biotech Inc., USA in a research project to develop cell expansion technology of cord blood hematopoietic stem cells, for use in clinical transplant
UCLA, National Taiwan University, Taipei Medical University, Taiwan’s Industrial Technology Research Institute to research cell expansion, as well as research treatments of diseases, disorders and injuries, such as those affected by spinal cord injuries.
What federal or state guidelines or regulations do you follow?
Is there a fee if the blood is ever needed for transplant?
Is your company stable?
Healthcare Professionals FAQs
What is your process for expectant parents?
Do you have a minimum amount of cord blood that must be collected?
What is the medical professional's responsibility before, during, and after the procedure?
What if, for medical reasons, collection of the cord blood is not possible?
How does HealthBanks process cord blood?
Source: New York Blood Center (97.9% sd 4.9%).
Does HealthBanks offer any training material or training courses to staff that have not done cord blood collections?
Do you have 24 hours a day, 7 days a week service for questions?
Does HealthBanks use a sterile collection bag for C-sections?
Heparin adversely affects total nuclear cell count (TNC) and CD34 contents of the cord blood, which are primary indicators of graft potency. Heparin breaks down after 48 hours* and does not nourish cells.
HealthBanks has chosen to use the FDA and NDA approved anticoagulant Citrate Phosphate Dextrose Solution** (CPD), a cell protector, also recommended by the Department of Health and Human Services, Center for Biologics Evaluation and Research, Guidance for Industry. ***
* Blood (ASH Annual Meeting Abstracts) American Society of Hematology “Cord Blood Units Collected with Liquid CPD Appear to Contain Significantly More Nucleated and CD34+ Cells Than Units Collected with Dry Heparin” Morey Kraus*,1, Karen Foster*,2, AsimenaRigas Bridges*,3 and Mark C. Walters, MD 4 2009 114: Abstract 4227 https://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/4227
** HealthBanks’s collection bag containing CPD is FDA NDA approved and CE marked under the Medical Devices Directive for the collection of placental/umbilical cord blood. https://webcache.googleusercontent.com/search?q=cache:8lRecQyv_kIJ:www.pall.com/medical_41560.asp+CPD+is+approved+by+the+FDA+for+cord+blood+collection&cd=3&hl=en&ct=clnk&gl=us
*** During collection of cord blood, we recommend that you use an appropriate closed, sterile container sealed in a manner that prevents cell loss and contamination. We recommend that you use only citrate-based anticoagulants.” U.S. Dept of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Guidance for Industry – Minimally Maninpulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hemapoietic Reconstitution for Specified Indications, October 2009
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Disclaimer: The use of cord blood and immune cells is determined by the treating physician and manufacturer of the final products and is influenced by many factors, including the patient's medical condition, the characteristics of the sample, and whether the immune cells should be further modified or expanded. Cord blood has established uses in transplant medicine; however, its use in regenerative medicine is still being researched. There is no guarantee that potential medical applications being studied in the laboratory or clinical trials will become available. Cord tissue use is still in early research stages, and there is no guarantee that treatments using cord tissue will be available in the future. Cord tissue is stored whole. Additional processing prior to use will be required to extract and prepare any of the multiple cell types from cryopreserved cord tissue. Immune cells has established uses in certain blood cancer treatment; however, its use in solid cancer is still being researched. There is no guarantee that treatments being studied in the laboratory, clinical trials, or other experimental treatments will be available in the future.
HealthBanks cryopreserves immune cells that have been collected from an individual for potential future cellular therapy use. HealthBanks does not provide medical advice, treatment or care. The use of cryopreserved cells for future immunotherapies is not guaranteed. Much is yet unknown about the future of immunotherapy and the immune cells that have been cryopreserved. The use of cryopreserved cells by commercial manufacturers for CAR-T therapy production is not currently approved by the FDA. There is active research ongoing, however, there is no guarantee that your cryopreserved cells will have a future therapeutic use. Only your health care professional can help you evaluate whether your cells might be used and if so, how they might be used. HealthBanks and its shareholders, directors, officers, agents, employees, affiliates, network of providers and provider facilities, will not be liable to you or any other party for claims relating to sample collection or if your cells cannot be used, or if any harm, injury, damage or loss results from the use of your cells. For more information, please refer to HealthBanks Service Agreement.
*Price Match is based on the same technology and service scope.