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A history of releasing cord blood units for therapy. “This shows they’re not just selling contracts to parents — there are doctors who are actually accepting units of cord blood that have been stored there for therapy,” says Frances Verter, Ph.D., founder and director of Parent’s Guide to Cord Blood Foundation, a nonprofit dedicated to educating parents about cord blood donation and cord blood therapists.
Umbilical cord blood units are made available for research studies intended to improve patient outcomes, as stated in the Stem Cell Therapeutic and Research Act of 2005, Public Law 109-129, and the Stem Cell Therapeutic and Research Reauthorization Act of 2010, Public Law 111-264.
Clinical experience with leading institutions: Many reputed hospitals have depended on the company for cord blood, including Duke University, Children’s Healthcare of Atlanta and the University of Minnesota Medical Center.
Barker JN, Davies SM, DeFor T, Ramsay NK, Weisdorf DJ, Wagner JE. Survival after transplantation of unrelated donor umbilical cord blood is comparable to that of human leukocyte antigen-matched unrelated donor bone marrow: results of a matched-pair analysis. Blood.2001;97 :2957– 2961
§ 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.
Cord blood banking is not always cheap. It’s completely free to donate blood to a public cord blood bank, but private banks charge $1,400 to $2,300 for collecting, testing, and registering, plus an annual $95 to $125 storing fee.
* Annual storage fees will be charged automatically to the credit/debit card on file, on or around your baby’s birthday, unless you’ve chosen a prepay option and are subject to change until they are paid.
Another important disadvantage that is not well understood by the general public is the limited use of an infant’s own umbilical cord blood stem cells later in life, called an autologous transplant. Commercial cord blood banks often advertise the banking of the infant’s cord blood as “biologic insurance.” However, the chance that a child would be able to use his or her own cord blood is extremely small: from a 1:400 to a 1:200,000 chance over the child’s lifetime (Sullivan, 2008). In fact, there are certain instances in which the use of one’s own umbilical cord blood is contraindicated, as in cases when the defect is of a genetic origin. For example, autologous cord blood stem cells cannot be used to treat malignant cancers such as leukemia because the genetic mutations for the cancer already exist on the DNA of the cord blood. Using one’s own stem cells would be, in effect, “contaminating” oneself with the same disease process (Percer, 2009).
Although cord blood is currently considered discarded human material, it should only be collected for banking with an institutional review board–approved protocol and with signed informed consent from a parent.42,43 Pertinent donor information communicated to the cord blood bank should be kept confidential by the cord blood bank and used only to report important medical information obtained during the cord blood collection, processing, and screening process that is relevant to the safety of the donor and family. If cord blood was collected from a newborn who subsequently developed a genetic, immunologic, or malignant neoplastic disorder, parents should notify the cord blood bank so that the unit is not used for transplantation. All cord blood units banked for potential use should be tested for infectious diseases, similar to those tested in a blood bank, and for hereditary hematologic diseases. The informed consent must contain information pertaining to what tests are to be performed on the cord blood and how the parents will be informed if test results are abnormal. Pediatricians should be aware that legal cases relating to the duty of a physician to warn parents about the risks of inheriting a genetic disease are new and untested. Pediatricians should remain vigilant, because future cases may define who has a legal duty to notify parents about genetic abnormalities identified during cord blood testing. Informed consent should be obtained before the onset of active labor and before cord blood collection.
The term “Cord Blood harvesting” has a slightly morbid sound, but in reality, it is a very worthwhile and potentially lifesaving field of medical science. Umbilical Cord blood is blood that remains in the umbilical cord after birth. This umbilical cord blood is full of stem cells, and these powerful cells can be harvested for use in medical testing, or for transplantation into another host. A transplantation of harvested umbilical cord blood can have a profound effect on the recovery of patients with a host of medical conditions such as leukemia, cancers, thalassemia, Diabetes and some other diseases.
Of particular interest are the flexible hematopoietic stem cells important in that initial transplant. In certain cases, transplanting these cells might be able to reboot a person’s body and get rid of a disease-related defect. Cord blood transplants are similar to bone marrow transplants. A person with leukemia, for instance, might have his own cancerous blood cells wiped out with chemotherapy and radiation. Healthy, non-cancerous stem cells from a donor can then repopulate the blood.
1. Spinal cord injury. In January, the Food and Drug Administration OK’d its first-ever human study of a medical treatment derived from human embryonic stem cells. The objective: help people with acute spinal cord injuries. While expected to assess only the safety of the treatment, the study also might show if the paralyzed volunteers can regain some feeling in and control over their lower extremities.
In the past years, there have been dramatic medical advances in the arena of stem cell research, and more discoveries are announced practically every month. Many doctors and researchers see great potential in the use of stem cells to reverse or cure many severe, life-threatening diseases. With these facts in mind, many parents are choosing to preserve the stems cells found in umbilical cord blood after birth. There are no health risks in doing so. The primary risk is that the $100 yearly fee for storage will be wasted in the event that the stem cells are never needed.
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Most of the diseases for which HSCT is a standard treatment are disorders of blood cell lineage. The proliferation by which blood cells are formed from stem cells is illustrated in the side graphic (click on the image to expand it); you can also read about specific cell types in the immune system in more detail. In the United States, most health insurance providers will pay for a stem cell transplant if it is a “standard therapy” for the patient’s diagnosis.
Smith F, Kurtzberg J, Karson E, et al. Umbilical cord blood collection, storage and transplantation: issues and recommendations for expectant parents and patients. Cancer Res Ther Control.1999;10 :217– 226
* Cbr Systems, Inc.’s activities for New York State residents are limited to collection of umbilical cord t style=”list-style-type: initial;”issue 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.
Fox N. S., Stevens C., Cuibotariu R., Rubinstein P., McCullough L. B., & Chervenak F. A. (2007). Umbilical cord blood collection: Do patients really understand? Journal of Perinatal Medicine, 35, 314–321 [PubMed]
Bunin N, Aplenc R, Iannone R, et al. Unrelated donor bone marrow transplantation for children with severe aplastic anemia: minimal GVHD and durable engraftment with partial T cell depletion. Bone Marrow Transplant.2005;35 :369– 373
Umbilical cord blood stem cells are different from embryonic stem cells. Umbilical cord blood stem cells are collected by your ob-gyn or a nurse from the umbilical cord after you give birth (but before your placenta is delivered). Embryonic stem cells are collected when a human embryo is destroyed.
5. Alzheimer’s disease. Likewise, embryonic stem cells may come in handy against Alzheimer’s disease, a progressive and deadly disorder that degrades and kills brain cells, leading to memory loss, cognitive decline, and behavioral problems. Stem cells may give rise to new treatments or even, some say, a cure; other experts have expressed skepticism.
Carolinas Cord Blood Bank, established in 1998, is one of the largest public cord blood banks. It’s affiliated with Duke University, where trials are currently taking place to treat children with cerebral palsy with their own cord blood. Parents can mail in their cord blood donations and receive financial aid if they have a sick older child or family member who can be treated with cord blood.
According to the statement, “Families may be vulnerable to emotional marketing at the time of birth of a child and may look to their physicians for advice. No accurate estimates exist of the likelihood of children to need their own stored cells. The range of available estimates is from 1 in 1,000 to 1 in 200,000.” For this and other reasons, it is difficult to recommend that parents store their children’s cord blood for future use. The AAP policy states:
The procedure of cord clamping can be delayed for a considerable period of time. However, the delay has to be a brief one. It cannot be delayed more than one or two minutes. If the procedure of clamping the cord is delayed for too long, the blood present in the cord might clot and once the blood clots it does not benefit anyone. Neither does it help your baby nor can it be collected for storage.
Some researchers suspect that umbilical cord blood contains other cells that may have therapeutic effects beyond the blood. Specialized immune cells may be able to tweak brain function, for instance. Trials around the world are studying umbilical cord blood’s capabilities in a wide range of diseases (see Table 2 here): Cerebral palsy, autism, diabetes and lupus are currently under investigation. The cells are even being tested for an ameliorating role in Alzheimer’s disease and other neurodegenerative conditions.
Accreditation agencies and registries have recognized StemCyte™ for its dedication to higher standards and patient care. StemCyte™ is the only private cord blood bank that is both FACT- and AABB-accredited.
Americord offers parents the ability to collect stem cells from the placenta and umbilical cord soon after the child’s birth. These stem cells, obtained from cord blood, cord tissue and placenta tissue, can be used to help treat genetic diseases and other threats to the baby’s life. Placenta tissue stem cells can also be used to benefit the mother.
You can also support your local research and academic institutions that are accepting cord blood donations. Stem cell research has become a provocative debate because of the ethical disagreements around embryonic stem cells. UCB avoids the debate entirely while still providing valuable stem cells in the quest to cure disease and mitigate human suffering.
With umbilical cord blood harvesting, the harvested cord blood does not come from the newborn baby itself; instead, the cord blood is harvested from the blood that remains in the umbilical cord after birth. Umbilical cord blood is never harvested from either mother or child, but only from the unused blood in the umbilical cord, which would otherwise be discarded waste. The harvesting procedure takes only a few minutes and there is zero danger to either the parent or the baby.
Quite simply, cord blood is the remaining blood from your baby’s umbilical cord and placenta after birth. Cord blood is loaded with our “stem cells” which are origins of the body’s immune and blood system and maybe the origin of other organs and important systems in the body. Stem cells are important because they have the ability to regenerate into other types of cells in the body.
Ozkaynak MF, Sandoval C, Levendoglu-Tugal O, Jayabose S. A pilot trial of tandem autologous peripheral blood progenitor cell transplantation following high-dose thiotepa and carboplatin in children with poor-risk central nervous system tumors. Pediatr Hematol Oncol.2004;21 :635– 645
Entz-Werle N, Suciu S, van der Werff Ten Bosch J, et al. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia.2005;19 :2072– 2081
In recent years, umbilical cord blood, which contains a rich source of hematopoietic stem and progenitor cells, has been used successfully as an alternative allogeneic donor source to treat a variety of pediatric genetic, hematologic, immunologic, and oncologic disorders. Because there is diminished risk of graft-versus-host disease after transplantation of cord stem cells using matched related donors, the use of less-than-completely matched HLA cord blood stem cells may incur less risk of graft-versus-host disease than mismatched cells from either a related or unrelated “walking” donor, although this remains to be proven. Gene-therapy research involving modification of autologous cord blood stem cells for the treatment of childhood genetic disorders, although experimental at the present time, may prove to be of value. These scientific advances have resulted in the establishment of not-for-profit and for-profit cord blood–banking programs for allogeneic and autologous cord blood transplantation. Many issues confront institutions that wish to establish or participate in such programs. Parents often seek information from their physicians about this new biotechnology option. This document is intended to provide information to guide physicians in responding to parents’ questions about cord blood donation and banking and the types and quality of cord blood banks. Provided also are recommendations about appropriate ethical and operational standards, including informed consent policies, financial disclosures, and conflict-of-interest policies for physicians, institutions, and organizations that operate or have a relationship with cord blood–banking programs.
When you consider that public banks can only expect to ship 1-2% of their inventory for transplant, you can quickly understand why most public banks are struggling to make ends meet. That struggle means that fewer collection programs are staffed, and there are fewer opportunities for parents to donate to the public good. We said earlier that public banks only keep cord blood donations over a minimum of 900 million cells, but today most public banks have raised that threshold to 1.5 billion cells. The reason is that the largest units are the ones most likely to be used for transplants that bring income to the bank. Family cord blood banks do not need to impose volume thresholds because they have a profit margin on every unit banked.
AABB accredited: Some cord blood companies have received extra accreditation from the AABB, or the American Association of Blood Banks, which means they meet a certain standard of service and accuracy of work.
“Processing” refers to separating the important components of the whole cord blood before cryopreservation. There are many methods used to process cord blood that can achieve the same goal: storing the important cells for potential future use. However, it’s important to point out some differences between methods:
The American Academy of Pediatrics (AAP, 2007) states that the use of banked umbilical cord blood as “biologic insurance” is unwarranted. The AAP also notes that many of the claims of private cord blood banks are unfounded. Unlike ACOG, the AAP recommends cord blood collection and banking for all families; however, their distinction is that all cord blood should be banked in public banks for use by the general population. In one study, the researchers reported that when pediatric transplant specialists were surveyed, overall, they did not recommend private cord blood banking (Thornley et al., 2009). The AAP recommends private cord blood banking only if a full sibling has a medical diagnosis for which stem cells are currently being used for treatment.
The potential powers of these cells have researchers excited. But what that scientific hope means for expectant parents facing decisions about cord blood banking is far from clear. For all of the promise, there are lots of reasons why umbilical cord cells may turn out to be less useful than thought. Read my next post for more about these potential drawbacks.
Depending on the predetermined period of storage, the initial fee can range from $900 to $2100. Annual storage fees after the initial storage fee are approximately $100. It is common for storage facilities to offer prepaid plans at a discount and payment plans to help make the initial storage a more attractive option for you and your family.
Jaing TH, Hung IJ, Yang CP, Chen SH, Sun CF, Chow R. Rapid and complete donor chimerism after unrelated mismatched cord blood transplantation in 5 children with beta-thalassemia major. Biol Blood Marrow Transplant.2005;11 :349– 353
Parents have the option to privately store their newborn’s cord blood stem cells. There are now over a dozen private cord blood banks, and more open every year. Some have their own labs, while others contract with a lab. Cord blood stem cell banking is not a regulated industry; there are no certifications or licensing requirements to open a cord blood bank. Several banks are accredited by the American Association of Blood Banks. Please keep in mind there is a big difference between being accredited by the AABB and being a member of the AABB. To be accredited, the lab must follow strict standards and be inspected by the association.
Families that are predisposed to certain diseases, that are ethnically mixed, that are adopting a newborn child, or that have a family member who may need a stem cell transplant should take special care to understand the value the cells may provide and their storage options.
Richardson SM, Hoyland JA, Mobasheri R, Csaki C, Shakibaei M, Mobasheri A. Mesenchymal Stem Cells in Regenerative Medicine: Opportunities and Challenges for Articular Cartilage and Intervertebral Disc Tissue Engineering. J Cell Physiol. 2010; 222(1):23-32.
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All cord blood banks in the US are required to register with Food and Drug Administration. To ensure safety, cord blood banks must comply with FDA regulations, including current good tissue practice regulations, donor screening and testing for infectious diseases, including HIV I & II (the virus that causes AIDS), Hepatitis B & C, which can cause liver disease, Cytomegalovirus (CMV) a virus that can lead to pneumonia, Human T-cell Lymphotropic Virus (HTLV) 1 & 2, which can suppress the immune system, West Nile Virus, Zika Virus, Treponema pallidum (the bacterium that can cause syphilis) and Variant Creutzfeldt-Jakob Disease (vCJD), a rare virus that can cause brain disease. Since 2011, the FDA has required public cord blood banks to obtain a license under a Biologics License Application.