Family Bank: Cord Blood Registry

About

Cord Blood Registry® (CBR®) is one of the world’s largest and most experienced newborn stem cell companies. Since 1992, families have entrusted CBR to store more than 1 million cord blood and cord tissue samples. CBR has helped over 700 families use their cord blood samples as part of a stem cell transplant or for investigational regenerative applications. In their mission to advance the real-life applications of newborn stem cells, CBR stays at the forefront of the science in this ever-evolving industry. They advocate for their clients by providing invaluable resources like genetic counselors and clinical specialists to help answer medical questions pertaining to newborn stem cells. They also created the Family Health Registry^TM. CBR client families who join the Family Health Registry are the first to know about important clinical trials that could potentially help their loved ones.

Labs and Locations

CBR’s laboratory is located in Tucson, Arizona, where cord blood and cord tissue collections are processed 365 days a year. Their state-of-the-art facility has the capacity to store five million newborn stem cell samples. 

Call 1.888.CORDBLOOD to (International callers can call 1.650.635.1420):

• Speak to a CBR Newborn Stem Cell Educator. They’re available Monday - Friday 6 AM - 8 PM PST or Saturday - Sunday 6 AM - 4 PM PST.
• Already a client? Speak with a Client Support Specialist for assistance with your account. You can also send them a message or request a call with them here.
• Get connected to a CBR Clinical Specialist if you have questions about how newborn stem cells may be applicable for your family history.
• Arrange pickup of your collection kit after birth.
• Reach a 24-hour emergency response hotline (available to clients only).

Business Experience

Over the past 30 years, CBR has maintained its leadership in the industry by storing more than 1 million cord blood and cord tissue collections from over 47,000 healthcare providers in more than 100 countries. They’ve also helped more than 700 families use their cord blood stem cells for established transplant medicine uses or investigational regenerative medicine uses for conditions that have no cure today.

Collection Kit

CBR utilizes the sterile Pall collection bag, which is pre-filled with citrate phosphate dextrose (CPD) anti-coagulant. An anticoagulant helps keep the cells from clotting during transportation. Having more cells available could mean more possibilities in the future.

In 2010, CBR pioneered cord tissue preservation in the U.S. CBR transports tissue in the CordCup® container, which contains an antibiotic solution that helps protect the tissue from contamination during transportation.

Transportation container

CBR’s validated, crush-resistant collection kit is built with a dense foam insulant that increases shock absorption and helps shield samples from extreme temperatures. It also helps ensure that their collection kit keeps samples safe and secure during transit.

Shipping Info

Whether you're delivering at a hospital, birthing center, or your home, CBR’s couriers can come straight to you within a few hours, 365 days a year. Airspace is CBR's courier of choice. CBR also provides a secure chain of custody through Airspace, which means all samples are electronically tracked. Families can receive text or email updates on shipping and delivery.

Processing Method

Cord Blood

CBR put a lot of thought into choosing their cord blood processing system. Fast, precise, and consistent results are a must—which is one of the many reasons CBR uses AutoXpress II® (AXP II®).

• AXP II® is an automated processing technology that reduces the risks often associated with manual processing.
• AXP II® uses centrifugation and an optical sensor to separate cells. Unlike other methods, it does not introduce chemical additives.
• The cord blood stem cell recovery data reported by CBR and others for AXP II® processing is consistently higher than the published data of other processing methods (see references below). 
• Why is cell recovery significant? Cord blood has a finite number of powerful stem cells. An efficient and precise processing method can mean a larger reserve of cells stored for your family’s future.

Cord Tissue

• As part of their Cord Tissue Complete^TM service, CBR first evaluates the health and quality of its clients’ cord tissue with ActivCord®, the first test of its kind to measure the health of the whole cord tissue.
• While cord tissue science is still in its early stages, CBR believes that the best in technology and applications is yet to come. And since extraction techniques may vary depending on how the cells are used, they believe storing cord tissue whole preserves the most possibilities for patients. All the data seems to indicate that the MSCs isolated from cryopreserved cord tissue retain the properties needed for future clinical use.
• This means preserving cord tissue now puts all its great cells in your family’s “back pocket,” helping to maximize potential future options.

References

1. Marzan AJ, Wilson C, Wheeler-Beunger J, Brown KS, Shamonki JM. Impact of Cord Blood Anticoagulant on Cell Recovery Following Volume and Red Blood Cell Reduction. Data to be presented at the AABB Meeting, 2020 October, virtual.
2. Rubinstein P. Cord blood banking for clinical transplantation. Bone Marrow Transplantation. 2009;44:635-642
3. Basford C, Forraz N, Habibollah S, Hanger K, McGuckin CP. Umbilical cord blood processing using Prepacyte-CB increases haematopoietic progenitor cell availability over conventional Hetastarch separation. Cell Prolif. 2009;42(6):751-761. doi:10.1111/j.1365-2184.2009.00646.x
4. Broxmeyer HE, Lee MR, Hangoc G, et al. Hematopoietic stem/progenitor cells, generation of induced pluripotent stem cells, and isolation of endothelial progenitors from 21- to 23.5-year cryopreserved cord blood. Blood. 2011;117(18):4773-7.
5. Solves P, Planelles D, Mirabet V, Blanquer A, Carbonell-Uberos F. Qualitative and quantitative cell recovery in umbilical cord blood processed by two automated devices in routine cord blood banking: a comparative study. Blood Transfus. 2013;11(3):405-411. doi:10.2450/2012.0037-12.

Components Stored

CBR stores newborn stem cells in the form of cord blood, cord tissue, or both.

• For cord blood, CBR uses the AXP II® processing method to remove plasma, reduce the red blood cells, and retain the hematopoietic stem cells.
• By freezing cord tissue in whole segments, CBR preserves all the potentially beneficial cell types, including mesenchymal, endothelial, and epithelial cells.
• CBR has a Quality Standard that all cord blood and cord tissue samples are measured against. If a sample’s results fall outside of these parameters, a clinical specialist will follow up with the family to review the results.
• Once their samples are successfully stored, families are given a Certificate of Deposit to print for their records. This can be accessed via the Client Center, so they can obtain their information anytime.

Storage Method

CBR uses a seamless, multi-compartment cryobag, offering more protection for your cord blood samples by decreasing the potential for breakage that can occur in traditional, seamed-plastic storage bags. Additionally, all cord blood and cord tissue samples are placed in a second overwrap layer of plastic, which is hermetically sealed, as an extra precaution.

All units are stored in dewars, which are large, insulated vessels specially designed for long-term cryostorage. Units are suspended above a pool of liquid nitrogen that creates a vapor-phase environment kept at minus 196 degrees Celsius. This keeps the units as cold as liquid nitrogen without immersing them in liquid, which can enable cross-contamination. CBR also protects clients’ samples in the following ways:

• Their storage facility is located in Tucson, Arizona, which historically has a low risk of natural disasters like earthquakes, tornadoes, hurricanes, and floods.
• Daily environmental monitoring checks are performed on storage tanks to ensure proper function.
• Investing millions of dollars to ensure proper backups of their critical power systems. This includes two 9,000-gallon backup tanks of liquid nitrogen.

Visit CBR’s Comparison Guide to learn more about their storage and laboratory facility.

How long can units remain viable in cryopreservation? Cord blood cells stored for 23 years have been shown to behave similarly to freshly collected cord blood cells (references).  Based on this information, it is believed that, when stored properly, cord blood units should be able to be stored indefinitely.

Licensing & Accreditation

CBR maintains standards for cellular therapy services through FDA registration, CLIA certification, and AABB accreditation. As a family cord blood storage provider, CBR adheres to standards from various regulatory agencies and accrediting bodies, including:

• FDA Tissue Establishment Registration
• FDA Medical Device Registration
• CLIA (Clinical Laboratory Improvement Amendment) Certification
• AABB Accreditation

Additionally, they have biologic and laboratory licenses in the following states:

• California
• Illinois
• Maryland
• New Jersey
• New York

Since quality management and consistency are so important to CBR, it has sought additional testing and licensing to become an ISO 9001:2015 certified facility. This way, clients know that CBR will handle each sample with the highest standards of care, consideration, and consistency.

Clinical Experience

Advancing the science of newborn stem cells is central to CBR’s mission. That’s why they were the first family newborn stem cell company to partner with leading research institutions to establish FDA-regulated clinical trials exploring the potential regenerative ability of cord blood stem cells to help treat conditions that have no cure today. These included autism, acquired hearing loss, cerebral palsy, and pediatric stroke. In addition to clinical trials, CBR has also released cord blood units for use in other investigational settings. In fact, 80% of the cord blood units released by CBR have been used for experimental regenerative therapies.

As of the end of 2022, CBR has released more than 700 cord blood samples for use by their client families. Fully 100% of the samples have been deemed suitable for use by the treating physician. CBR also has a dedicated and highly experienced Transplant Team that helps simplify the use process for families and the treating facility.

Insurance

CBR takes quality seriously. They also understand that parents are making an investment in their newborn’s stem cells. That’s why CBR informs families about the quality of their samples, helping them protect their investment.

• Quality Standard. CBR tests every cord blood sample for cell count, sterility, and viability. Also, every cord tissue sample receives CBR's ActivCord test. CBR alerts families if the results fall below the defined parameters that CBR has set.
• Quality Service Guarantee. If cord blood stem cells fail to engraft during transplantation, customers receive a full refund for cord blood services plus an additional $50,000.

Community Service

Since it was founded, CBR has allocated millions of dollars to support its Newborn Possibilities Program® (NPP). The NPP assists families with a qualifying medical need by covering all costs for processing their child’s newborn stem cells and preserving them for five years. As of Sept. 2021, the NPP has enrolled more than 10,000 families.

Prices

• Payment plans for initial fees start at $52 per month.
• Annual storage is $205 per sample, per year.
• CBR offers special pricing for military and returning families.
• While it is recommended to set up an account well in advance of the due date, no payment is due until after birth. Learn more about the affordable options here.
• Services are also provided for families delivering outside the U.S.

Additional Services

Newborn Possibilities Program

Families with a qualifying medical need can apply for five years of free preservation through CBR’s Newborn Possibilities Program. It’s CBR’s way of taking care of families that need it the most. If you think your family may qualify, call to speak with a Genetic Counselor. Experts are just a phone call away. CBR’s team of genetic counselors are here to guide families through each step of the preservation process and answer questions about how newborn stem cells may be applicable for their family history.