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Family Bank: Cord Blood Registry
Labs and Locations
Cord Blood Registry is headquartered in South San Francisco, California. CBR owns their 80,000 square foot laboratory located in Tucson, Arizona. CBR's laboratory processes cord blood collections seven days a week, 365 days a year. The state-of-the-art facility has the capacity to store the stem cell samples of five million newborns.
CBR Cord Blood Education Specialists are available 7 days a week (Monday - Friday 6 AM - 9 PM PST and Saturday - Sunday 6 AM - 4 PM PST) to respond to consumer inquiries. In addition, consumers may request to schedule a call with a CBR Cord Blood Education Specialist at a specific date and time.
Phone 1-888-932-6568 to connect with a CBR Cord Blood Education Specialist or submit an online request. International callers should phone 650-635-1420 to connect with a CBR Cord Blood Education Specialist.
In addition, CBR offers Genetic Counselors on staff to help families make informed decisions about newborn stem cell banking. Phone 1-888-CORDBLOOD1-888-CORDBLOOD to speak with a CBR Genetic Counselor.
A 24 hour emergency response hotline is available to clients.
Founded in 1992, CBR has stored more than 600,000 cord blood and cord tissue collections from 3,500 hospitals in over 100 countries and partnered with institutions to establish multiple FDA-regulated clinical trials. CBR has helped more than 400 families use their cord blood stem cells for established and experimental medical treatments, more than any other family cord blood bank. CBR's goal is to expand the potential scope of newborn stem cell therapies that may be available to patients and their families.
CBR created the world's only collection device designed specifically for cord blood stem cells. CBR has the highest average published cell recovery rate in the industry - 99% - resulting in the capture of 20% more of the most important cells than other common processing methods.
The unpredictability of stem cell transportation led CBR to create a crush-resistant, temperature-protected, and electronically tracked collection kit that is designed to preserve the integrity and to help ensure the safe delivery of the blood and/or tissue. CBR's CellAdvantage® Collection Kit contains everything the healthcare provider needs to easily and safely collect the maximum amount of a newborn's cord blood following birth.
CBR collection kits have been designed to shield the samples from extreme temperatures (shielding for more than 1 hour at extreme hot and cold). Samples remain at room temperature and are shipped directly to the CBR lab for processing.
On average, the transport time for stem cells from the hospital to CBR's lab is 19 hours. CBR partners with Quick International, a private medical courier service with 30 years of experience in the transportation of blood and tissue for transplant and research.
Upon arrival at CBR's laboratory, the kit is immediately checked in and inspected. Next, the cord blood unit is tested for sterility, viability, and cell count. In addition, the cord tissue is tested for sterility. CBR processes cord blood using the AutoXpress® Platform* (AXP®) - a fully automated, functionally closed stem cell processing technology. The AXP platform is an integral component of CBR's proprietary CellAdvantage® system. CBR has the industry’s highest published average cell recovery rate of 99%.
*AXP and AutoXpress are registered trademarks of Cesca Therapeutics.
AutoXpress™ Platform (AXP) cord blood processing results in a red-cell reduced stem cell product. Each sample is stored in a cryobag consisting of two compartments (one major and one minor) and two integrally attached segments used for unit testing. At time of storage, the client is provided with a certificate (via their online account) that indicates the total viable nucleated cell count for their child's cord blood.
Unlike other banks, CBR uses a seamless cryobag for storage. The seamless construction decreases the potential for breakage that can occur in traditional, seamed-plastic storage bags. Prior to storage, each cryobag is placed in a second overwrap layer of plastic, which is hermetically sealed as an extra precaution against possible cross contamination by current and yet unidentified pathogens that may be discovered in the future. CBR stores the stem cells in vaults, called dewars, specially designed for long-term cryostorage. The cord blood 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. Cryopreserved cord blood stem cells have proven viable after more than 20 years of storage, and research suggests they should remain viable indefinitely.
Licensing & Accreditation
CBR maintains standards for cellular therapy services through AABB accreditation, FDA-registration, and CLIA certification.
CBR was the first family bank accredited by AABB (formerly the American Association of Blood Banks) and the company's quality standards have been recognized through ISO 9001:2008 certification—the global business standard for quality. The Federal Drug Administration (FDA) has issued cord blood regulations, and the states of California, Illinois, Maryland, New York and New Jersey have mandatory licensing for cord blood banking. The stringent laboratory processes, record keeping, quality control and quality assurance of CBR are designed to meet all federal and state guidelines and regulations.
The evolution of stem cell therapies has paved the way for further research being conducted through FDA-regulated clinical trials to uncover their potential in regenerative medicine applications. Cord Blood Registry is 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, including: acquired hearing loss, autism, cerebral palsy, and pediatric stroke. In fact, 73% of the stem cell units released by CBR have been used for experimental regenerative therapies – more than any other family cord blood bank in the world.
Sutter Neuroscience Institute is conducting a landmark FDA-regulated phase II clinical trial to assess the use of autologous stem cells derived from cord blood to improve language and behavior in certain children with autism.
Georgia Regents University is conducting an FDA-regulated phase I/II clinical trial to assess whether an infusion of autologous stem cells derived from their own cord blood can improve the quality of life for children with cerebral palsy.
Florida Hospital for Children is conducting an FDA-regulated phase I clinical trial to investigate the use of a child's stem cells derived from their own cord blood as a treatment for acquired sensorineural hearing loss.
The University of Texas Health Science Center at Houston is conducting a pioneering FDA-regulated phase I/II clinical trial to compare the safety and effectiveness of two forms of stem cell therapy in children diagnosed with cerebral palsy. The randomized, double-blinded, placebo-controlled study aims to compare the safety and efficacy of an intravenous infusion of autologous cord blood stem cells to bone marrow stem cells.
An FDA-regulated clinical trial will soon investigate the use of a child's own cord blood stem cells as treatment after a pediatric stroke.
CBR clients have participated in additional trials examining the use of children's own cord blood at the University of Florida (type 1 diabetes) and Duke University (hypoxia and cerebral palsy).
In the rare event of a sample not adhering to quality standards, CBR's certified genetic counselors will work with potential clients to help them understand their options. Under this scenario, clients will have the option to discontinue storage and receive a refund.
If clients need to use the cord blood stem cells stored with CBR for transplantation and the cells fail to engraft, clients receive a full refund of all fees paid to CBR for cord blood services plus an additional $50,000.
Cord Blood Registry’s Newborn Possibilities Program® serves as a catalyst to advance newborn stem cell medicine and science for families that have been identified with a medical need to potentially use newborn stem cells now or in the near future. NPP offers free cord blood and cord tissue processing and five years of storage to qualifying families. To date, the Newborn Possibilities Program has processed and saved stem cells for nearly 6,000 families.
Cord Blood Registry offers two ways to save your newborn's stem cells, and convenient payment options to fit your family's needs. CBR recognizes that each family's budget is unique. As a result, CBR does not take a one-size-fits-all approach to pricing and payments for cord blood and tissue banking. Calculate your stem cell banking costs and CBR will recommend payment plans that may fit your family's budget.
Learn more here.
Families have the additional option of storing a section of the umbilical cord, which is rich in unique and powerful stem cells that may help repair and heal the body in different ways than stem cells derived from cord blood.
Learn more here.