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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.
Cord blood collection is a completely painless procedure that does not interfere with the birth or with mother-and-child bonding following the delivery. There is no risk to either the mother or baby. Cord blood collection rarely requires Blood Center staff to be present during the baby’s delivery. There is no cost to you for donating.
Chemotherapy and radiation therapy generally affect cells that divide rapidly. They are used to treat cancer because cancer cells divide more often than most healthy cells. However, because bone marrow cells also divide frequently, high-dose treatments can severely damage or destroy the patient’s bone marrow. Without healthy bone marrow, the patient is no longer able to make the blood cells needed to carry oxygen, fight infection, and prevent bleeding. BMT and PBSCT replace stem cells destroyed by treatment. The healthy, transplanted stem cells can restore the bone marrow’s ability to produce the blood cells the patient needs.
Potential long-term risks include complications of the pretransplant chemotherapy and radiation therapy, such as infertility (the inability to produce children); cataracts (clouding of the lens of the eye, which causes loss of vision); secondary (new) cancers; and damage to the liver, kidneys, lungs, and/or heart.
Brigham and Women’s Hospital and Dana-Farber Cancer Institute jointly oversee the Cord Blood Donation Program to provide hope to all patients in need of a life-saving stem cell transplant. For more information about the stem cell transplant program please visit The Stem Cell/Bone Marrow Transplant Program at Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) web site.
The American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics don’t recommend routine cord blood storage. The groups say private banks should only be used when there’s a sibling with a medical condition who could benefit from the stem cells. Families are encouraged to donate stem cells to a public bank to help others.
Because only a small amount of bone marrow is removed, donating usually does not pose any significant problems for the donor. The most serious risk associated with donating bone marrow involves the use of anesthesia during the procedure.
The baby’s cord blood will be processed and stored in a laboratory facility, often referred to as a blood bank. The cord blood should be processed and stored in a facility that is accredited by the American Association of Blood Banks (AABB) for the purpose of handling stem cells.
In this way, cord blood offers a useful alternative to bone marrow transplants for some patients. It is easier to collect than bone marrow and can be stored frozen until it is needed. It also seems to be less likely than bone marrow to cause immune rejection or complications such as Graft versus Host Disease. This means that cord blood does not need to be as perfectly matched to the patient as bone marrow (though some matching is still necessary).
The immune system has a way to identify foreign cells; it’s what allows the body to defend itself. So although transplants were proving successful after the first in 1956, they were limited to twins because their shared genetic makeup made them 100 percent compatible. This took a turn in 1958, when scientists discovered a protein present on the surface of almost all cells that lets the body know if the cell is one of its own cells or a foreign cell. In 1973, we finally learned enough about these compatibility markers (called human leukocyte antigens or HLAs) to perform the first unrelated bone marrow transplant.
Private or family banks store cord blood for autologous use or directed donation for a family member. Private banks charge a yearly fee for storage. Blood stored in a private bank must meet the same standards as blood stored in a public bank. If you have a family member with a disorder that may potentially be treated with stem cells, some private banks will store the cord blood free of charge.
Cord blood banks may be public or commercial. Public cord blood banks accept donations of cord blood and may provide the donated stem cells to another matched individual in their network. In contrast, commercial cord blood banks will store the cord blood for the family, in case it is needed later for the child or another family member.
Donating your baby’s umbilical cord blood may offer a precious resource to a patient in need of a life-saving stem cell transplant. Umbilical cord blood is rich in blood-forming stem cells, which can renew themselves and grow into mature blood cells. After your baby is born, these cord blood cells can be collected, preserved and later used as a source of stem cells for transplantation for patients with leukemia, lymphoma, and other life-threatening blood diseases.
CBR Clients: Did you know that when you refer a friend, and they preserve their baby’s stem cells with us, you receive a free year of cord blood storage? After your first referral, you start earning even more rewards. (exclusions apply). Refer a friend now: http://bit.ly/2JAGrcu
Tracey said she felt lucky since she banked Anthony’s cord blood with a private company. And Osteopetrosis is one of 80 diseases listed by many cord blood companies in their marketing material as treatable with stem cells.
There is often confusion over who can use cord blood stem cells in treatment — the baby they were collected from or a sibling? The short answer is both, but it very much depends on the condition being treated. And it’s ultimately the treating physician’s decision.
Properly preserved cord blood is long-lasting. Cord blood is stored in a nitrogen freezer (the same technology used to freeze donated sperm), so it can last for a long time. “The scientist who first developed cord blood preservation methods in 1990 has confirmed that some of the first specimens he stored 23 plus years ago are just as potent as fresh cord blood,” says Mary Halet, Director, Central Region at Be The Match, which is operated by the National Bone Marrow Foundation.
There are options for relieving the financial burden associated with BMT and PBSCT. A hospital social worker is a valuable resource in planning for these financial needs. Federal government programs and local service organizations may also be able to help.
Cord blood is also being studied as a substitute for normal blood transfusions in the developing world. More research is necessary prior to the generalized utilization of cord blood transfusion.
In the United States, the Food and Drug Administration regulates any facility that stores cord blood; cord blood intended for use in the person from whom it came is not regulated, but cord blood for use in others is regulated as a drug and as a biologic. Several states also have regulations for cord blood banks.
^ Roura S, Pujal JM, Gálvez-Montón C, Bayes-Genis A (2015). “Impact of umbilical cord blood-derived mesenchymal stem cells on cardiovascular research”. BioMed Research International. 2015: 975302. doi:10.1155/2015/975302. PMC 4377460 . PMID 25861654.
There are usually two fees involved in cord blood banking. The first is the initial fee that covers enrollment, collection, and storage for at least the first year. The second is an annual storage fee. Some facilities vary the initial fee based upon the length of a predetermined period of storage.
If everyone donated cord blood to public registries for the ‘common good’ this would increase the chances of someone benefiting from a double cord blood transplant. This far outweights the actual probability of the person who donated the sample being able to usefully use it for themself.
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. Cbr Systems, Inc.’s activities for New York State residents are limited to collection of umbilical cord tissue and long-term storage of umbilical cord–derived stem cells. Cbr Systems, Inc.’s possession of a New York State license for such collection and long-term storage does not indicate approval or endorsement of possible future uses or future suitability of these cells.
All medical costs for the donation procedure are covered by Be The Match®, or by the patient’s medical insurance, as are travel expenses and other non-medical costs. The only costs to the donor might be time taken off from work.
Banking cord blood is a new type of medical protection, and there are a lot of questions that parents may want to ask. The Parent’s Guide to Cord Blood organization even has questions it believes all parents should ask their cord blood banks. We have answers to these and other frequently asked cord blood questions in our FAQs. If you can’t find the answer for which you are looking, please feel free to engage one of our cord blood educators through the website’s chat interface.
In March 2004, the European Union Group on Ethics (EGE) has issued Opinion No.19 titled Ethical Aspects of Umbilical Cord Blood Banking. The EGE concluded that “[t]he legitimacy of commercial cord blood banks for autologous use should be questioned as they sell a service, which has presently, no real use regarding therapeutic options. Thus they promise more than they can deliver. The activities of such banks raise serious ethical criticisms.”
The stem cells used in PBSCT come from the bloodstream. A process called apheresis or leukapheresis is used to obtain PBSCs for transplantation. For 4 or 5 days before apheresis, the donor may be given a medication to increase the number of stem cells released into the bloodstream. In apheresis, blood is removed through a large vein in the arm or a central venous catheter (a flexible tube that is placed in a large vein in the neck, chest, or groin area). The blood goes through a machine that removes the stem cells. The blood is then returned to the donor and the collected cells are stored. Apheresis typically takes 4 to 6 hours. The stem cells are then frozen until they are given to the recipient.
The majority of programs that accept cord blood donations require the mother to sign up in advance. In the united States, the current requirement is to sign up by the 34th week of pregnancy. This cannot be over-stressed; time and time again, mothers who want to donate are turned away because they did not inquire about donation until it was too late.
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.
In the rare event of a processed 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.
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.
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Are public banks and family banks the same, except for who may use the cord blood and the cost to the parents? No. Public banks are subject to much higher regulatory requirements, and compliance with regulations carries costs. At a family bank you pay the bank enough to cover the cost of storing your baby’s cord blood, plus they make a profit. When you donate to a public bank, it costs you nothing, but the bank pays more on processing each blood collection than at a family bank. Let’s look at the steps that take place in the laboratory.
We believe that every family should have the opportunity to preserve their baby’s newborn stem cells. That’s why CBR offers transparent costs of cord blood banking, and various payment options to fit this important step into almost every family budget.
Both public and family cord blood banks must register with the US Food and Drug Administration (FDA), and since Oct. 2011 public banks also need to apply for an FDA license. All cord blood banks are required by federal law to test the blood of the mother for infectious diseases. At public banks the screening is usually more extensive, similar to the tests performed when you donate blood. The typical expense to a public bank is $150 per unit.
As the research into umbilical cord blood and it’s therapeutic use for blood diseases has grown, so has the question as to whether people should privately store the cord blood of their offspring for future use. A recent paper on this issue by Mahendra Rao and colleagues advocates the practice of cord blood banking (for treatment of blood diseases) but in the context of public cord blood banks rather than a private cord blood banks. Any adult needing treated would need at least two cord blood samples that are immune compatible. So one sample will not be sufficient. A child might only need one cord blood sample but in the case of childhood leukaemia there is a risk that pre-leukemic cells are present in cord blood sample – and so the child could not use their own cells for therapy.
Research is being conducted using cord blood cells to analyze immune response and other factors that may eventually shed light on causes and treatment of MS. However, at present there is no treatment available involving cord blood cells. Nor do we know of any sites that are looking for cord blood specifically for MS research.
Only three to five ounces of blood is collected from each umbilical cord. This small amount is enough to treat a sick child, but not an adult, unless multiple units of matched cord blood are used, says William T. Shearer, M.D., Ph.D., professor of Pediatrics and Immunology at Baylor College of Medicine in Houston.
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.
Bone marrow transplantation (BMT) and peripheral blood stem cell transplantation (PBSCT) are procedures that restore stem cells that have been destroyed by high doses of chemotherapy and/or radiation therapy. There are three types of transplants: