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A “clinical trial” is a study in human patients for an emerging therapy that has not been adopted as standard therapy. This website has pages that enable patients to search worldwide for currently recruiting clinical trials with ether cord blood or umbilical cord tissue MSC. The table below checks off all diagnoses that have ever been treated in clinical trials with cord blood or cord tissue, regardless of whether the trials are still open.
After injections with their own umbilical cord blood, 63 children with cerebral palsy improved on motor skills, on average. And a clinical trial to see whether cord blood transplants improve symptoms of children with autism spectrum disorder should wrap up in the summer of 2018, says pediatric researcher and clinician Joanne Kurtzberg of Duke University, who helped establish a not-for-profit umbilical cord bank in North Carolina. (A small but optimistic pilot study has already been completed.)
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.
Another advantage of using umbilical cord blood stem cells is the decreased risk of the transmission of infectious disease. This particular advantage is partly because umbilical cord blood is almost never contaminated by Epstein-Barr virus or cytomegalovirus (Drew, 2005; Gonzalez-Ryan et al., 2000). Additionally, the processing of cord blood includes collecting data on the history of infection during the mother’s pregnancy. For example, if the pregnant woman has a history of group B streptococcus, active genital herpes, or prolonged rupture of membranes and chorioamnionitis, umbilical cord blood is not saved. Generally, samples of the mother’s blood are also drawn to test for infectious diseases, such as hepatitis, human immunodeficiency virus, and syphilis (Moise, 2005). Furthermore, after the cord blood units are collected, they are screened for disease, and any units that are deemed contaminated or infected are thrown away (Gunning, 2007).
Regulatory agencies (eg, FDA, Federal Trade Commission, and state equivalents of these federal agencies) are encouraged to have an active role in providing oversight of the cord blood program. All cord blood–banking programs should comply with FACT or equivalent accreditation standards.
After harvesting, the umbilical cord blood is taken to a cord blood bank where it will be tested to make sure that it is clear of disease and other contaminants. Before being frozen, a cryopreservant is added to the cord blood so that the stem cells are able to be frozen without damaging them, after which they are stored in a liquid nitrogen Cord Blood storage tank at –196 Celsius.
‡ Payment Plan Disclosures for in-house CBR 6-Month Plan (interest free) – No credit check required. The 6-month plan requires a $10/month administrative fee. The plans may be prepaid in full at any time.
That may sound expensive, but the cost of processing cord blood and storing it in medical freezers for years on end is considerable. Even public cord blood banks say the initial collection, processing, and storage cost them about $1,500 per unit of cord blood.
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
Check if the cord blood bank you’re considering is accredited with the American Association of Blood Banks (AABB). AABB is an international, not-for-profit organization that has been setting standards for both public and private cord blood banking companies for over 20 years. LifebankUSA is registered with the FDA and accredited by AABB. Click here for a list of AABB-accredited cord blood banking companies in the U.S. and around the world.
There are several advantages of using umbilical cord blood stem cells over bone marrow stem cells for transplants (see Table 2). The first advantage is that umbilical cord blood is relatively easy to collect and process. Once considered a substance to be thrown away after a birth, now the cord blood can be easily saved. After it is saved and sent to a storage facility, the cord blood is quickly available for use within days to weeks after processing. In contrast, bone marrow stem cells can take much longer to find a match, collect the sample, and process. The process for bone marrow transplantation can take from weeks to months. The collection process for cord blood is not painful to either mother or child and can be done either prior to or after the delivery of the placenta (Gonzalez-Ryan, VanSyckle, Coyne, & Glover, 2000; Percer, 2009). Bone marrow transplants, on the other hand, require the donor to be hospitalized, anesthetized, and experience postcollection pain and discomfort. Thus, compared to cord blood, bone marrow collection and transplantation of stem cells are more costly (Drew, 2005; Moise, 2005).
One of the key things you’ll want the cord blood bank’s representative to explain to you is how the cord blood bank collects and stores cord blood. Collection and storage methods may differ across cord blood banking companies, and you’ll want to be sure that the cord blood bank complies with all federal standards.2
Back in the 1980s, umbilical cord blood caught the attention of researchers who suspected that the often-discarded tissue could be a valuable source of shape-shifting stem cells. These cells, which can become several different types of blood cells, are similar to the specialized stem cells found in bone marrow that can churn out new blood cells. Such stem cells are found in adult blood, too, but not as abundantly.
Bielorai B, Trakhtenbrot L, Amariglio N, et al. Multilineage hematopoietic engraftment after allogeneic peripheral blood stem cell transplantation without conditioning in SCID patients. Bone Marrow Transplant.2004;34 :317– 320
Cord blood contains stem cells that can save lives. Patients requiring a stem cell transplant will receive cells from one of three sources: bone marrow, circulating blood, or umbilical cord blood. The first two exist in all healthy adults, but cord blood can only be harvested and stored at birth
Families should seriously pursue public banking, donation for research, or private banking instead of discarding their baby’s umbilical cord blood. We aim to be nonpartisan in our dissemination of information, but we believe that discarding your baby’s cord blood is a waste of a once-in-a-lifetime valuable resource.
Additional ethical concerns about umbilical cord blood banking involve the timing of clamping the umbilical cord after birth. Overall, the issue of when to clamp and cut the umbilical cord is controversial. There is no consensus on how early or how late in the birthing process the umbilical cord ought to be clamped and cut, although the cord obviously still provides nourishment and removes waste until it is clamped or spontaneously stops pulsing (Lothian & DeVries, 2010). However, some practitioners might clamp the umbilical cord early in an effort to maximize the amount of cord blood obtained for banking, and thus “short change” the child and allow the infant to become anemic (Drew, 2005).
New England Cord Blood Bank was founded in 1971 and is one of the pioneers in processing and cryopreservation of human cells and tissue. The company is continuing to expand its research and development center.
Cord blood specimens for non-clinical scientific research studies are also available through the Cord Blood Transplantation (COBLT) Study, funded by the National Heart Lung and Blood Institute (NHLBI)
Cord blood banking means preserving the newborn stem cells found in the blood of the umbilical cord and the placenta. After a baby is born, and even after delayed cord clamping, there is blood remaining in the umbilical cord and placenta that holds valuable newborn stem cells. Parents have a choice between donating cord blood to a public bank for free, or paying to store it for their family in a private bank. Cord blood banking includes the whole process from collection through storage of newborn stem cells for future medical purposes.
Cord blood can be used in the treatment of nearly 80 life-threatening diseases – from cancers to blood disorders. It’s also being used in regenerative medicine research to help kids with conditions like Autism and Cerebral Palsy.
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).
2. Diabetes. For the many Americans with type 1 diabetes, whose insulin-making pancreatic cells have been killed off by their immune system, stem cells may be the answer. Last year, scientists reported that they had coaxed human embryonic stem cells into becoming insulin-producing, blood sugar-regulating cells in diabetic mice. The aim: to someday do the same for people.
With public cord blood banks, there’s a greater chance that your cord blood will be put to use because it could be given to any child or adult in need, says William T. Shearer, M.D., Ph.D., professor of Pediatrics and Immunology at Baylor College of Medicine in Houston. Cord blood is donated and is put on a national registry, to be made available for any transplant patient. So if your child should need the cord blood later in life, there’s no guarantee you would be able to get it back.
RENECE WALLER-WISE is a licensed clinical nurse specialist and childbirth educator at Southeast Alabama Medical Center in Dothan, Alabama. She is also an adjunct faculty member at Troy University in Troy, Alabama.
While some companies may advertise their cord tissue preservation service as “treatment-ready”, this is a misnomer. In the U.S. there are currently no treatments available that use cord tissue cells. Without knowing what the treatment protocols may look like in the future, preserving the cord tissue sample whole today means that all of the available cell types in this precious resource may be available to your family in the future.
Cord blood has been used for 20 years to treat more than 80 serious diseases.34 Successful treatments have paved the way for further research and today, FDA-regulated clinical trials are exploring the use of a child’s own stem cells for conditions that currently have no cure.
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.
Some financial aid is available for families that opt for private cord blood banking. If you have a sick child who could benefit from umbilical cord blood, some cord blood banks offer programs in which the bank will cover free cord blood processing and storage if the baby has a biological sibling with certain diseases. Certain insurance companies may pitch in if that sibling needs to be treated with the cord blood in the near future, Dr. Verter says.
Accurate information about the potential benefits and limitations of allogeneic and autologous cord blood banking and transplantation should be provided. Parents should be informed that autologous cord blood would not be used as a stem cell source if the donor developed leukemia later in life. Parents should recognize that there are no scientific data to support the claim that autologous cord blood is a tissue source proven to be of value for regenerative medical purposes. The current standard uses of cord blood transplantation are listed in Table 1.
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.
When researching cord blood banks, make sure they’re registered with the Food and Drug Administration (FDA), and comply with FDA regulations including current good tissue practice regulations, donor screening and testing for infectious diseases. Check for accreditations with American Association of Blood Banks or the Foundation for the Accreditation of Cellular Therapy. Other factors to consider are the bank’s shipping and delivery methods, clinical experience, processing options, payments and costs.
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Four main types of physical conditions are treated with stem cell transplants: cancers, blood disorders, congenital metabolic disorders, and immunodeficiencies (see Table 1). Examples of cancers that are treated with stem cells are both lymphoma and leukemia. Nonmalignant hemologic disorders also account for a fair share of the recipients of stem cells. Examples of these blood disorders are various types of anemias, such as sickle-cell anemia and Fanconi’s anemia (the first disorder treated with umbilical cord blood stem cells). Stem cells have also been used to treat various metabolic disorders, such as adrenoleukodystrophy. The fourth major category of uses for stem cells is in treating immunodeficiencies, such as Duncan’s disease or adenosine deaminase deficiency (Drew, 2005; Moise, 2005).
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
These are diagnoses for which stem cell treatments are being studied either in the laboratory with cell cultures or in animals that mimic the human disease. The experimental therapies are not yet in human clinical trials. In experimental research, it is often not clear whether an eventual therapy, if developed, would be Autologous or Allogeneic.
Ravindranath Y, Chang M, Steuber CP, et al. Pediatric Oncology Group (POG) studies of acute myeloid leukemia (AML): a review of four consecutive childhood AML trials conducted between 1981 and 2000. Leukemia.2005;19 :2101– 2116
Not all moms can donate their cord blood. Moms who are not eligible are those who: are younger than 18 years old (in most states), have been treated for cancer or have received chemotherapy for another illness, have had malaria in the last three years, or have been treated for a blood disease such as HIV or hepatitis. It’s also not possible to donate cord blood if a mom has delivered her baby prematurely (there may not be enough blood to collect) or delivered multiples (but it’s possible to bank your cord blood of multiples privately).