Frequently Asked Questions (FAQs)

Cord Blood FAQs

What are stem cells?

Stem cells are the building blocks of life, and a foundation for a new age in medicine. Beginning as undifferentiated cells, stem cells possess the remarkable ability to develop into any of the more than two-hundred cell types in the human body.

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)?

Bone marrow, peripheral blood, and umbilical cord blood constitute the three primary sources of stem cells. UCB is the blood present in the umbilical cord and the placenta. Not long ago, the umbilical cord and the placenta would be discarded as biological waste, as in the past we did not understand cord blood's true value. The first cord blood transplant was conducted in 1988 in Paris*.

*http://ccbb.duke.edu/about-cord-blood/history-cord-blood*

What are the advantages of umbilical cord blood?

Umbilical cord blood, an abundant source of stem cells, is the blood in both the umbilical cord and the placenta. Today, cord blood stem cells can be used to treat nearly 80 diseases including several forms of cancer and blood-related diseases, immunity and metabolic disorders and diseases. Bone marrow, peripheral blood and umbilical cord blood are the main sources of stem cells. For clinical transplantation of human hematopoietic stem cells (HSCs), umbilical cord blood offers many advantages. Bone marrow transplantation has become a widespread therapy but major drawbacks include unavailability of matched bone marrow, a rather invasive process to the donor to harvest the bone marrow, and more life-threatening transplant-related complication including graft-versus-host disease (GVHD), which may develop. Cord blood is easy and painless to collect, readily available when needed, and minimizes potential complications associated with GVHD. Because of these factors, transplantation of umbilical cord blood is rapidly becoming the stem cell source of choice.

Why should I collect and store my baby's cord blood?

Banking your newborn's umbilical cord blood stem cells can be one of the smartest, farthest-reaching decisions you can make when it comes to the health and wellness of your child. Taking the steps to safely store life-saving cells can put any parent's mind at ease. Using one's own stem cells for therapy is often referred to as “personalized medicine” and is considered the new frontier in medicine. The advances in stem cell research are staggering. More and more parents are taking advantage of the 15-minute window of opportunity to collect their newborn's cord blood and cryopreserve it as "biological insurance."

Who should strongly consider cord blood banking services?
  1. Families with a higher predisposition to certain diseases, i.e. blood disorders, immunodeficiency diseases and cancers.
  2. 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.
  3. 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.
  4. Children with a mixed ethnic background have a lower chance of finding a human leukocyte antigens (HLA) tissue matched sample.
  5. 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?

The cord blood collection process is simple, safe, and does not interfere with your delivery. It is also painless for both the mother and newborn. Ultimately, your physician will determine whether it is safe to collect your baby's cord blood.

Can you collect cord blood if the delivery is by C-Section?

Yes. Collection for a C-Section delivery is very similar to that of a vaginal delivery. The primary difference is that your physician or midwife who will be performing the collection will use PacifiCord's FDA approved sterile (and Heparin-free) collection bag provided in the PacifiCord Collection Kit to safely collect the cord blood.

Using PacifiCord'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.* PacifiCord 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.**

**PacifiCord'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. http://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

After banking my first child's cord blood, is it necessary to bank my second child's?

Yes. Although the success in matching human leukocyte antigens (HLA) between siblings is much higher than people with no blood relation, there is still a very high chance of HLA matching being unsuccessful. It is therefore better to store the child's own cord blood sample.

With twins, is it necessary to store both babies’ cord blood? And what is required for multiple births?

It is best to store each baby's sample individually which provides for either two identical human leukocyte antigen (HLA) typed samples in the case of identical twins or two different HLA-typed samples which may be the case with non-identical twins. Multiple births will require the use of additional collection kits. PacifiCord offers special pricing for multiple births.

Why is it important to choose a cord blood bank close to my home?

Studies have shown it is important to process and store your cord blood within 48-hours of collection. But sooner is better. Being in close proximity to our facility means we are better situated to accomplish this. Our goal is to process the majority of samples within 24-hours of collection and avoid use of air transport which can be disrupted or delayed due to weather and other uncontrollable events. Have you ever experienced flight delays and lost luggage?

What is the process for a cord blood collection for an adopted baby?

Assuming that the adopting parents have a relationship with the birth mother prior to the birth of the adopted baby, the adopting parents would arrange with the delivering physician their plan for collecting the adopted baby's cord blood. The adopting parents would follow the same procedure as any other PacifiCord customer for enrollment, including bringing the PacifiCord Collection Kit to the hospital at the time of delivery.

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?

Donating cord blood for public use or storing it for your family's private use is a personal decision. There are certain requirements to donate publically including your health, whether your maternity hospital has a public cord blood donation program and the suitability of the sample after collection among other factors. More information can be found at: www.marrow.org. Once donated to a public cord bank, the parents have no claim on the unit and would have to purchase it back if needed, and still available.

If the baby has an inherited genetic disorder, can his/her cord blood still be used in the future?

At the present time, cord blood stem cells can be used to treat leukemia, lymphoma and other blood disorders. However, there are over 4,000 clinical trials word-wide that are researching the future applications of stem cells such as regenerative medicine, tissue engineering and, more specifically in this case, gene therapy. In the future, the baby's own stem cells may be modified and infused back into the body to treat genetic disorders without being rejected by the body's immune system since the cord blood stem cells are the child's own cord blood stem cells. If autologous (one's own) stem cells are not available or cannot be used, the best option for successful therapy is to secure stem cells from an HLA-matched sibling.

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.”

Click here for the article.

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. PacifiCord 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. PacifiCord 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.”

Click here for the article.

Does the hospital need to provide any materials for collection?

No. You will receive a PacifiCord Collection Kit for your baby's cord blood stem cells. Your kit contains all the items your healthcare professional will need to collect your baby's cord blood. However, you must remember to take the collection kit with you to the hospital when you deliver.

What will affect the collection volume of the cord blood?

The volume of the cord blood collected depends on the thickness and the length of the umbilical cord plus the weight of the placenta and baby. It also depends on the course of delivery, as the safety of the mother and the baby always come first. The collection technique is also an important factor. PacifiCord provides the hospital staff, obstetricians and midwives with training on cord blood collection procedures.

If the cord blood volume is low (<40g ), can it still be banked?

The cord blood can be banked even if the volume is low. Low volume does not always equate to low cell numbers which is an important factor for use in transplants. Also cell expansion and other scientific research are underway which may result in the ability to use smaller samples. There is also the new emerging area of regenerative medicine which utilizes a variety of different stem cells to possibly treat a whole array of diseases, injuries and conditions including, traumatic brain injury, corneal repair, cardiovascular disease and many others.

What is the likelihood of ever using our baby's cord blood?

When contemplating whether or not to bank your baby's cord blood, take into consideration not only the nearly 80 different diseases that can now be treated with cord blood stem cells today, but also think about the amazing potential of cord blood stem cells to prevent, treat, and enhance your child's quality of life tomorrow. Thousands of cord blood transplants have been performed in the past few years and that number is expected to grow. If the cord blood stem cells are stored properly for future use, as is done by PacifiCord's state-of-the-art technology, and with the anticipated advances of cord blood stem cells involving prevention, treatment and quality of life, PacifiCord researchers estimate that there is an 80%+ chance of using cord blood stem cells in one's lifetime.

PacifiCord FAQs

When should I enroll with PacifiCord?

Because half of all babies arrive before their due date, it's best to decide early. While we strongly recommend making the decision during your second trimester, however, it's never too late in your pregnancy to enroll.

How do I enroll with PacifiCord to save my baby's cord blood?

We offer several methods of enrollment for your convenience. Enrollment options include:

  1. We offer several methods of enrollment for your convenience. Enrollment options include:
  2. Phone: 1.888.379.2670
  3. Online: www.PacifiCord.com

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 of $2300 includes:

  1. A Sterile PacifiCord Collection Kit (100% inspected, FDA approved stem cell protectant, Heparin-free and convenient for cord blood collection for vaginal births and cesarean sections).
  2. Premium cord blood stem cell processing with the AXP™ AutoXpress™,known for the highest published cell recovery in the industry, saving more cells for your baby.
  3. 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 PacifiCord Difference: [email protected]/ 1.888.379.2670

What collection method does PacifiCord use?

The collection method is fairly standard. A large majority of medical professionals are trained and have performed numerous cord blood collections for both public and family cord blood banks.

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, PacifiCord 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 PacifiCord's collection bag is Heparin-free.

PacifiCord 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.***

*PacifiCord'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. http://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 http://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/4227

How does PacifiCord process cord blood?

PacifiCord utilizes the FDA cleared AXP™ AutoXpress™to process its cord blood. The AXP enables PacifiCord 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 PacifiCord 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 PacifiCord use?

PacifiCord 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. PacifiCord, 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 PacifiCord?

A unique benefit to choosing PacifiCord to process and store your cord blood is that we are local. While being local has many benefits to both you and your newborn's cord blood, one of them is that we are able to employ our own local service to pick up your cord blood unit and deliver it directly to our laboratory.

Why does PacifiCord store cord blood in liquid nitrogen (LN2) versus using vapor?

One of the most common questions asked is, "How long can my cells be stored?" Storage temperature is critical to the long term survival and viability of stem cells. All published studies on long term storage were done using liquid phase nitrogen. There are no published studies on effects of long term storage using vapor. Liquid phase storage is the best guarantee that your stem cells are being stored at the optimal temperature. It is why most of the world's leading public cord blood banks store in liquid, not vapor. The other key point is that your sample will be left undisturbed which is only possible through the use of robotics-a key feature of our storage system, the BioArchive®, the leading stem cell storage and retrieval system.

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."

Click here for the article

What testing is performed by PacifiCord?

We test the maternal blood for specific infectious diseases. The cord blood is tested for sterility as well as the number and viability of the cells collected.

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 ourBioArchive® 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?

Your baby's stem cells will be stored at PacifiCord, located in Irvine, California within our state-of-the-art facility that has been specifically designed to withstand natural disasters, keeping your baby's stem cells safe. It is also important to note that Irvine, according to the FBI, has been recognized as one of the safest cities in the United States. It's an ideal environment for safely storing umbilical cord blood stem cells.

PacifiCord 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, PacifiCord'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 PacifiCord'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 PacifiCord is FDA registered and inspected for cord blood stem cell processing and is compliant with all regulations. PacifiCord 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 PacifiCord.

Are PacifiCord's processing methods and results published?

The methods we employ have been published by the New York Blood Center, the world’s largest and oldest public cord blood bank. They have the largest and longest running clinical study on using cord blood for bone marrow transplants.

Does PacifiCord perform research?

In conjunction with the HealthBanksBioTech family, PacifiCord has invested in millions of dollars in relevant research and development projects, including those involving umbilical cord blood stem cells. While performing research on our own, we continue to work with researchers at a wide range of universities, research organizations and medical institutions, such as:

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 Universityin 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?

PacifiCord is a licensed State of California Department of Health and AABB accredited facility in compliance with California Health and Safety Code, California Business and Professional Code and California Code of Regulations. PacifiCord is also FDA registered and inspected, as well as a standing member of the Better Business Bureau and Irvine Chamber of Commerce.

Is there a fee if the blood is ever needed for transplant?

There is no charge by PacifiCord other than the cost to ship your cord blood unit where required.

Is your company stable?

Yes. PacifiCord, in association with four additional cord blood locations and three research and development subsidiaries worldwide, is a member of the HealthBanks family of companies, which for over 22 years has been a leader in pharmaceuticals, stem cell therapy, development and research.

Healthcare Professionals FAQs

What is your process for expectant parents?

We request that expecting parents enroll in their first or second trimester though it is possible to enroll right up until time of delivery. Upon enrollment, PacifiCord will mail the customer a PacifiCord Collection Kit (unless the customer received one of our kits from our office)-we encourage our customers to correspond with their healthcare professional/s regarding their plans for cord blood collection in advance of their delivery. Expecting parents are instructed to bring the cord blood collection kit with them to the hospital when they go into labor. The kit contains all of the required materials and instructions for the healthcare professional performing the cord blood collection following either a vaginal or cesarean birth. The process of collecting the cord blood is easy and takes about five minutes. Once the cord blood collection is complete, the PacifiCord customer is required to call PacifiCord to arrange the pick-up of the collected cord blood unit. PacifiCord will process the cord blood within 24-hours or less provided we are contacted within a short time after collection.

Do you have a minimum amount of cord blood that must be collected?

No. Cord blood volume does not necessarily correlate to cell count (TNC and MNC). As a result, PacifiCord will determine whether or not there are sufficientcord blood stem cells for storage upon cell analysis and inform the customer of all results.

What is the medical professional's responsibility before, during, and after the procedure?

Prior to the collection procedure, the medical professional would be responsible for ensuring that other medical professionals in the practice are aware that the patient will have her baby's cord blood collected. During the procedure the medical professional is responsible for collecting the cord blood. After the collection procedure, the medical professional is responsible for filling out the cord blood collection worksheet, packing and labeling the contents of the collection kit and returning it to the patient.

What if, for medical reasons, collection of the cord blood is not possible?

We inform our customers that the collection of their newborn's cord blood is performed solely at the discretion of their healthcare professional. We leave it up to the healthcare professional to determine whether or not it is safe for the cord blood to be collected.

How does PacifiCord process cord blood?

PacifiCord utilizes the FDA cleared AXP™ AutoXpress™to process its cord blood. The AXP enables PacifiCord 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 PacifiCord 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%).

Does PacifiCord 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?

Yes. Please call 1.888.379.2670 24 hours a day, 7 days a week with any questions that arise.

Does PacifiCord use a sterile collection bag for C-sections?

Yes. PacifiCord's FDA approved sterile (and Heparin-free) collection bag is provided in the PacifiCord Collection Kit for the physician, nurse or midwife to safely collect the cord blood. 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.

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.

PacifiCord 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 http://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/4227

** PacifiCord'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. http://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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