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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.
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.
Osteopetrosis is a genetic disease, so this means that doctors could use a sibling’s cord blood cells to treat Anthony, but they cannot use his own cells because the disease is in every cell in his body. In fact, a majority of the diseases listed in private banking firms’ marketing material as treatable with stem cells are genetic diseases.
Choosing a bank (specifically a private bank) for her daughter’s cord blood made perfect sense to Julie Lehrman, a mom based in Chicago. “We wanted the extra assurance that we were doing everything we could to keep Lexi healthy,” Lehrman says. “I was older when Lexi was born, and there’s a lot we didn’t know about my mom’s health history, so we felt that we were making a smart decision.” Fortunately, Lexi was born healthy, and neither she nor anyone else in the family has needed the cord blood since it was stored seven years ago. But Lehrman has no regrets; she still feels the family made a wise investment. “Lexi or her brother or even one of us could still need that blood in the future, so I’m thankful that we have it.” But banking your child’s cord blood may not be the right decision for you. Read on to see if you should opt for private cord blood banking.
There are a number of different processing methods out there for a cord blood bank to use, and the processing method can ultimately affect the purity of the final product, which we’ll explain in a minute. Once the stem and immune system cells have been isolated and extracted from the plasma and red blood cell, they are mixed with a cryo-protectant and stored in a cryo-bag. We overwrap our bags for added protection and use a technique called “controlled-rate freezing” to prepare the cells for long-term storage. The overwrapped cryo-bag is housed in a protective metal cassette and placed in vapor-phase liquid nitrogen freezer for long-term preservation.
A list of U.S. transplant centers that perform allogeneic transplants can be found at BeTheMatch.org/access. The list includes descriptions of the centers, their transplant experience, and survival statistics, as well as financial and contact information.
Cord Blood banking is a confusing topic. Many parents get bombarded with information when searching to see if cord blood banking is right for them. There is information that private cord blood banking companies, like Viacord and Cord Blood Registry, will not tell you, until now.
Umbilical cord blood is being studied for potential use in a wide variety of life-threatening diseases because it is a rich source of blood stem cells. Transplantation of blood stem cells from umbilical cords has been used successfully to treat several pediatric blood diseases, including sickle cell anemia and cancers such as leukemia and lymphoma. This procedure is still considered investigational. There is currently no solid evidence that umbilical cord blood stem cells have the ability to be transformed into other types of cells, such as replacement nerve tissue or myelin-making cells.
Why should you consider donating the cord blood to a public bank? Simply because, besides bringing a new life into the world, you could be saving an individual whose best chance at life is a stem cell transplant with your baby’s donated cord blood. This can only happen if you donate and if your baby is a close enough match for a patient in need. If you chose to reserve the cord blood for your family, then siblings who have the same parents have a 25% chance of being an exact match.
A cord blood bank may be private (i.e. the blood is stored for and the costs paid by donor families) or public (i.e. stored and made available for use by unrelated donors). While public cord blood banking is widely supported, private cord banking is controversial in both the medical and parenting community. Although umbilical cord blood is well-recognized to be useful for treating hematopoietic and genetic disorders, some controversy surrounds the collection and storage of umbilical cord blood by private banks for the baby’s use. Only a small percentage of babies (estimated at between 1 in 1,000 to 1 in 200,000) ever use the umbilical cord blood that is stored. The American Academy of Pediatrics 2007 Policy Statement on Cord Blood Banking stated: “Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood.” and “private storage of cord blood as ‘biological insurance’ is unwise” unless there is a family member with a current or potential need to undergo a stem cell transplantation. The American Academy of Pediatrics also notes that the odds of using a person’s own cord blood is 1 in 200,000 while the Institute of Medicine says that only 14 such procedures have ever been performed.
A “mini-transplant” (also called a non-myeloablative or reduced-intensity transplant) is a type of allogeneic transplant. This approach is being studied in clinical trials for the treatment of several types of cancer, including leukemia, lymphoma, multiple myeloma, and other cancers of the blood.
Because identical twins have the same genes, they have the same set of HLA antigens. As a result, the patient’s body will accept a transplant from an identical twin. However, identical twins represent a small number of all births, so syngeneic transplantation is rare.
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Several research teams have reported studies in animals suggesting that cord blood can repair tissues other than blood, in diseases ranging from heart attacks to strokes. These findings are controversial: scientists often cannot reproduce such results and it is not clear HOW cord blood may be having such effects. When beneficial effects are observed they may be very slight and not significant enough to be useful for developing treatments. If there are positive effects, they might be explained not by cord blood cells making nerve or heart cells, but by the cells in the cord blood releasing substances that help the body repair damage.
To recap, we have certain types of stem cells that can become a variety of different cells—they are like the renaissance men of cells—but there is one more thing that makes stem cells special. This has to do with how they replicate themselves.
However, parents should know that a child’s own cord blood (stored at birth), would rarely be suitable for a transplant today. It could not be used at present to treat genetic diseases, for example, because the cord blood stem cells carry the same affected genes and. if transplanted, would confer the same condition to the recipient. (See the story of Anthony Dones.) In addition, most transplant physicians would not use a child’s own cord blood to treat leukemia. There are two reasons why the child’s own cord blood is not safe as a transplant source. First, in most cases of childhood leukemia, cells carrying the leukemic mutation are already present at birth and can be demonstrated in the cord blood. Thus, pre-leukemic cells may be given back with the transplant, since there is no effective way to remove them (purge) today. Second, in a child with leukemia, the immune system has already failed to prevent leukemia. Since cord blood from the same child re-establishes the child’s own immune system, doctors fear it would have a poor anti-leukemia effect.
The Cord Blood Registry (CBR) is unique, because it is currently the world’s largest cord blood bank, with over a half-million cord blood and cord tissue units stored to date. This is substantially more than its nearest competitor, ViaCord, which has 350,000 units stored. It was recently acquired by pharmaceutical giant, AMAG Pharmaceuticals, for $700 million in June 2015.
As most parents would like to bank their babies’ cord blood to help safeguard their families, it is often the cost of cord blood banking that is the one reason why they do not. Most cord blood banks have an upfront fee for collecting, processing and cryo-preserving the cord blood that runs between $1,000 and $2,000. This upfront fee often also includes the price of the kit provided to collect and safely transport the cord blood, the medical courier service used to expedite the kit’s safe shipment, the testing of the mother’s blood for any infectious diseases, the testing of the baby’s blood for any contamination, and the cost of the first full year of storage. There is then often a yearly fee on the baby’s birthday for continued storage that runs around $100 to $200 a year.
Cord blood in public banks is available to unrelated patients who need haematopoietic stem cell transplants. Some banks, such as the NHS bank in the UK, also collect and store umbilical cord blood from children born into families affected by or at risk of a disease for which haematopoietic stem cell transplants may be necessary – either for the child, a sibling or a family member. It is also possible to pay to store cord blood in a private bank for use by your own family only.
Certain public cord blood banks let you mail in your cord blood. You have to decide before the birth if you want to donate your cord blood. If the hospital where you’re delivering doesn’t accept donations, you can contact a lab that offers a mail-in delivery program. After you’ve passed the lab’s screening process, they’ll send you a kit that you can use to package your blood and mail it in, explains Frances Verter, Ph.D., founder and director of Parent’s Guide to Cord Blood Foundation (parentsguidecordblood.org), a nonprofit dedicated to educating parents about cord blood donation and cord blood therapists.
Further advancements were made in 1978, when stem cells were discovered in cord blood and in 1988, when cord blood stem cells were first used in a transplant. Stem cells extracted from the umbilical cord blood or tissue have since been shown to be more advantageous than those extracted from other sources such as bone marrow. In many ways, this is because stem cells from the umbilical cord can be considered naïve and immature compared to stem cells from other sources. Cord stem cells haven’t been exposed to disease or environmental pollutants, and they are more accepting of foreign cells. In this case, inexperience makes them stronger.
After being treated with high-dose anticancer drugs and/or radiation, the patient receives the stem cells through an intravenous (IV) line just like a blood transfusion. This part of the transplant takes 1 to 5 hours.
Cade Hildreth is the Founder of BioInformant.com, the world’s largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine.
To prevent graft-versus-host disease and help ensure engraftment, the stem cells being transfused need to match the cells of the patient completely or to a certain degree (depending on what is being treated). Cord blood taken from a baby’s umbilical cord is always a perfect match for the baby. In addition, immediate family members are more likely to also be a match for the banked cord blood. Siblings have a 25 percent chance of being a perfect match and a 50 percent chance of being a partial match. Parents, who each provide half the markers used in matching, have a 100% chance of being a partial match. Even aunts, uncles, grandparents and other extended family members have a higher probability of being a match and could possibly benefit from the banked cord blood. Read more reasons why you should bank cord blood.
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:
To minimize potential side effects, doctors most often use transplanted stem cells that match the patient’s own stem cells as closely as possible. People have different sets of proteins, called human leukocyte-associated (HLA) antigens, on the surface of their cells. The set of proteins, called the HLA type, is identified by a special blood test.
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.”
Your child may never need it. Stem cell-rich cord blood can be used to treat a range of diseases, but Frances Verter, Ph.D., founder and director of Parent’s Guide to Cord Blood Foundation, estimates that there’s only a 1 in 217 chance that your child will ever need a stem cell transplant with cord blood (or bone marrow). This is particularly true if the child doesn’t have a family history of diseases such as leukemia, lymphoma, or sickle cell anemia. Although the American Academy of Pediatrics (AAP) states cord blood has been used to treat certain diseases successfully, there isn’t strong evidence to support cord blood banking. If a family does choose to bank cord blood, the AAP recommends public cord blood banking (instead of private) to cut down on expenditures.
In most cases, the success of allogeneic transplantation depends in part on how well the HLA antigens of the donor’s stem cells match those of the recipient’s stem cells. The higher the number of matching HLA antigens, the greater the chance that the patient’s body will accept the donor’s stem cells. In general, patients are less likely to develop a complication known as graft-versus-host disease (GVHD) if the stem cells of the donor and patient are closely matched.
The American Academy of Pediatrics supports efforts to provide information about the potential benefits and limitations of cord blood banking and transplantation so that parents can make an informed decision. In addition, the American College of Obstetricians and Gynecologists recommends that if a patient requests information on umbilical cord blood banking, balanced information should be given. Cord blood education is also supported by legislators at the federal and state levels. In 2005, the National Academy of Sciences published an Institute of Medicine (IoM) report titled “Establishing a National Cord Blood Stem Cell Bank Program”.
Tracey Dones of Hicksville, N.Y., paid to bank her son Anthony’s cord blood. But four months after he was born, Anthony was diagnosed with osteopetrosis, a rare disease that causes the body to produce excess bone, leads to blindness, and can be fatal if left untreated.
Another way scientists are working with stem cells is through expansion technologies that spur replication of the cord blood stem cells. If proven effective and approved by the U.S. Food and Drug Administration, these expansion technologies will allow scientists to culture many stem cells from a small sample. This could provide doctors and researchers with enough stem cells to treat multiple family members with one cord blood collection or provide the baby with multiple treatments over time. To better prepare for the day when these expansion technologies are more easily accessible, some cord blood banks have begun to separate their cord blood collections into separate compartments, which can easily be detached from the rest of the collection and used independently. You can learn more about Cryo-Cell’s five-chambered storage bag here.