FAQs

Most of the stem cells in cord blood are blood-forming stem cells, also known as “hematopoietic” stem cells or HSC. The presence of HSC is what enables cord blood transplants to be used as a substitute for bone marrow transplants. However cord blood transplants have advantages and disadvantages compared to stem cell transplants from adult donors. The main advantage of cord blood is that it does not have to be exactly matched to the patient like transplants from an adult donor. The main disadvantages are that it is hard to collect enough cord blood to transplant an adult, and cord blood stem cells are slower to engraft.

Cord blood also has applications in regenerative medicine. This is due to a combination of additional types of stem cells in cord blood, plus the fact that the cells in cord blood release chemicals that signal the body to heal itself. These chemicals are called cytokines and the cell-to-cell signaling is called the paracrine effect. Cord blood has been used in clinical trials around the world as therapy for infants with cerebral palsy and other brain injuries. Published studies have shown that cord blood stem cells benefit young children with neurologic injury, even though the mechanism of action is not yet fully understood. Additional clinical trials are applying cord blood to neurologic conditions in adults, including stroke, multiple sclerosis, and spinal cord injury.

Cord blood banking refers to the whole process of collecting and preserving the stem cells that remain in the blood of the umbilical cord and the placenta after the birth of a baby. Today, many private cord blood banks also offer storage of newborn stem cells from the tissue of the umbilical cord and/or the placenta.

Within the United States, healthcare providers can order shipments of our printed parent brochures for free in both English and Spanish. Parent's Guide to Cord Blood Foundation has developed educational brochures for parents that cover both public donation and private banking in a balanced way. Our brochures are available for download from cordbloodeducation.org in over a dozen languages and dialects, with the content adjusted to the national situation in different countries. These brochures were approved by our Scientific and Medical Advisory Panel and within the United States they are updated annually to adjust prices and include new clinical trials.

Our Foundation has also developed several Fact Sheets for medical professionals that are available for download from doctorsguidecordblood.org.

The median size of cord blood collections in family banks is 60mL or 2 ounces. That small volume of blood corresponds to 470 million Total Nucleated Cells (TNC) or 1.8 million cells that test positive for the stem cell marker CD34.  Thus, most healthy full-term babies have over a million blood-forming stem cells for cord blood banking. By comparison, most public cord blood banks will only keep collections that are much bigger than average, and throw out the donations that are below a threshold of a billion TNC, corresponding to a blood volume of about 100 mL or 3 ounces.

Reference:
Sun, JJ et al., Transfusion Sept. 2010; 50(9):1980-1987 doi:10.1111/j.1537-2995.2010.02720.x

If you live in the United States, we have a searchable map of all hospitals that accept cord blood donations. We are the only website that has a complete map and we work in partnership with the national donor registry Be The Match to update it quarterly.

In other countries we do not have this level of detailed information. Your best option is to look up the list of public banks in your country and contact them to find out where they accept donations.

There is no medical reason why parents should have to register for cord blood donation weeks in advance. Given adequate staffing and efficient management, a public cord blood bank could check the mother's health history and offer the family Informed Consent when they arrive at the hospital to give birth. Examples of public cord blood banks in the Untied States that accept walk-in donations are the NY Blood Center and the Cleveland Cord Blood Center.

However, most public cord blood banks in the United States do not have enough dedicated staff to handle donation requests, so in order to process them they require that mothers register weeks ahead of their due date. About five years ago the registration deadline was at 36 weeks, but as of 2016 the deadline is 34 weeks gestation.

In the United States, about 80% of cord blood donations are discarded. The primary reason is that the collection volume is too small. Public banks exist to provide transplants for patients throughout the world, and hence they only store cord blood donations that are big enough to transplant a large child or small adult. On top of that medical requirement to only accept the bigger collections, in recent years public banks have raised their storage thresholds in response to economic pressures.

Reference:
Magalon et al. 2015 Banking or Bankrupting: Strategies for Sustaining the Economic Future of Public Cord Blood Banks PLOS ONE doi:10.1371/journal.pone.0143440

Although a few such cases have actually happened, it is very very unlikely to get your cord blood back once it is donated. Donating cord blood is not a way of banking for your family for free.

When a mother signs the Informed Consent form to donate cord blood, she gives up any guaranteed access to that blood. First of all, the public bank may throw the blood out simply because it does not meet their size threshold, or simply because the paperwork is not complete. Secondly, even if the blood does make it into public storage, it may be released to some one else. 

Unlike organ donors, cord blood donors do not receive any priority treatment or waived fees if your child later needs a donor. The reward for donating cord blood is the possibility that your baby may Be The Match that saves a life.

Although several cord blood banks in India are licensed to conduct public banking, our research finds that for several years there have been virtually no cord blood transplants in India from public banks. The only banks providing donor (allogeneic) cord blood transplants in India right now are Community Banks.

We have compiled this information from the annual reports of World Marrow Donor Association (WMDA). Public cord blood banks operate under strict international regulations. They must report to WMDA each year how many transplants they have released, and whether those releases stay in their native country or travel to another country.

In the graph below, we plot red bars with numbers on the right vertical axis displays cord blood transplants in India each year, either from public banks in India or shipped into India from other public banks. There were only two transplants per year in 2017 and 2018, and none since. Meanwhile, the blue line with numbers on the left vertical axis plots all cord blood transplants in the geographic region that the WMDA calls "Asia". In other Asian countries combined, there are over 1500 cord blood transplants per year.

The Parent's Guide to Cord Blood Foundation recommends that parents select a Family Bank whose laboratory has been inspected by an accreditation agency specific to cord blood banking: AABB or FACT.  This provides a degree of quality assurance.

In some countries, national regulations hold Family Banks to the same standards as Public Banks, so an independent accreditation is not necessary. But in most countries the federal requirements for Family Banks are not as strict as Public Banks, and then a voluntary accreditation is desirable.  For example, in the United States the FDA registers and inspects Family banks, but does not require them to have a Biologics License (BLA) like Public Banks. 

Caveat: The process of registering with an accreditation agency and getting inspected can take a year, so it is understandable if a brand new lab does not have an accreditation yet.

Parents often complain about cord blood banking costs. This is not an industry where costs can be cut by running a turn-key operation. Each cord blood unit must be individually tested and processed by trained technicians working in a medical laboratory. 

To explain why cord blood banking is so expensive in the United States, we wrote an article with the CEO of a public cord blood bank that lists the steps in cord blood banking and itemizes the cost of each one.

Another contributor to cord blood banking costs is the quality of the collection kit. Cheaper banks typically use flimsy collection kits. To insure the survival of newborn stem cells, the shipping container should be thermally insulated to maintain kit temperature during cord blood shipments.

A cord blood industry report by Parent’s Guide to Cord Blood Foundation found that, among developed nations, cord blood banking cost is only 2% of the annual income of those households likely to bank.

For those families who want to preserve newborn stem cells privately, our website lets parents compare cord blood bank prices in each country.

Donating your baby’s cord blood to a public bank is always free. The limitations of the public banking network in the United States are: they only collect donations at large birthing hospitals in ethnically diverse communities, the mother must pass a health screening, they prefer registration by 34 weeks of pregnancy, and they only save the largest cord blood collections. The potential reward of public donation is that your baby could Be The Match to save a life!

Public cord blood banks throughout the world have adopted a time window of 48 hours as the maximum delay from birth to the initiation of lab processing.  It would be a "best practice" if family banks also followed the 48 hour window.

Some data points:

• FACT accreditation standards require the 48 hour window for public donations but allow 72 hours for family banks.
• AABB accreditation standards do not specify a time window.
• The US FDA recommends the 48 hour window.
• The US state of NY Dept. of Health requires a 48 hour window. 

Accreditations are quality standards. We describe each one on our Accreditation Standards page.

Cord blood laboratories that are located in certain countries are required by federal law to follow high standards: these include GMP in Germany, HTA in the UK, Swissmedic in Switzerland and TGA in Australia.

In the United States, public cord blood banks are required to get a Biologics License from the FDA, but family cord blood banks are only required to register with the FDA and undergo surprise inspections.

There are two voluntary accreditation systems that have been developed specifically for cord blood banking and are based on inspections of the laboratory procedures: AABB and FACT.  By comparison, ISO accreditation is not specific to cord blood banking.  Parent’s Guide to Cord Blood Foundation recommends that parents choose a family bank that has AABB or FACT accreditation, if one is available in your country. In our 2015 Cord Blood Industry Report, we found that accredited cord blood banks are NOT more expensive on average that banks with no accreditation.

Cryogenically frozen cord blood can be stored for decades and still be a viable source of stem cells for therapy. This conclusion is based on studies by Dr. Hal Broxmeyer, the man who invented cord blood storage in the 1980's. He contributed an article "How Long Can Cord Blood Be Stored?" for our newsletter of Sept. 2014.

These are all ways of counting cell types, and they tell you whether or not your cord blood collection has lots of stem cells and if they are healthy.

Stem cells happen to be Mono-Nuclear Cells or MNC: when you look at them under a microscope there is only one nucleus.  Unfortunately, one of the most difficult aspects of stem cell biology is that you can't identify a stem cell just by looking at it.  There are other types of blood cells which are also MNC, such as nucleated red blood cells.  The only proof that a cell is a stem cell comes from how it behaves when it multiplies. 

Scientists have worked for years to develop various chemical stains which have a high affinity for stem cells.  The best known marker for blood-forming stem cells is that they test positive for CD34, a protein found on the surface of stem cells.  But, CD34+ counts are not an accurate measure of stem cells: CD34+ results vary between labs, they can vary within a single lab, and only 1-2% of the MNC that have CD34+ are actually stem cells.

The Total Nucleated Cell count or TNC is the test most often reported as a measure of the cell count after cord blood processing.  The main advantage of measuring TNC is that the count is highly reproducible within and among labs, so it can be used accurately throughout the blood banking community.  Even better, the TNC count can be automated with the use of a device called a flow cytometer.

At present Colony Forming Units or CFU are considered to be the best measure of whether stem cells are "viable", or quite frankly alive.  The TNC count includes both living and dead cells.  In the CFU test a small portion is watched under controlled conditions to see if stem cells divide and form colonies.  This used to be a subjective measure, but recently it has been standardized with technology to image the cells and count colonies in the image.  The only remaining problem with the test is that it takes days for colonies to grow.

• Does the bank collect the whole umbilical cord or only a segment?
• Does the bank freeze the umbilical cord intact or process it before storage?
• Does the bank store a tissue product (for example minced cord) or a cellular product (isolated cells from the tissue)?
• If the bank stores a tissue product, have they validated that upon thawing this tissue they can retrieve viable stem cells? This means not just testing for markers of stem cells but confirming there are cells that can grow in culture.
• If the bank stores isolated cells, what tests do they run to characterize the population of cells that go into storage?
• Does the bank culture the isolated cells to expand their numbers before storage?
• Does the bank offer any guarantees about the number of or quality of cord tissue stem cells that the bank will provide if the client requests them for therapy?
• Does the bank have AABB accreditation for tissue processing (a somatic cell activity)?

• How long has the company been banking cord blood? 
• Who directs the day-to-day business of the company?  Many cord blood banks have famous doctors on their Board of Directors; but they are not involved with the day-to-day operations.
• What is their inventory of stored cord blood units?  Make sure to ask how many families banked cord blood with them. Many banks want to tell you how many "units" they have banked, but there could be multiple units per family (for cord blood, cord tissue, multiple storage containers)
• How many cord blood collections has the bank released for therapy?

• Are there any coupons currently available?  Most banks are constantly running a "special limited time offer".
• Is the enrollment fee charged once per family, or for each birth?
• Is the first year of storage included in the processing fee?
• If there is an annual storage fee, is it guaranteed not to increase?
• Are there any discount programs? Some banks offer discounts to medical professionals or military personnel.
• Do parents have the option of a partial or full refund if they decide not to store the cord blood for any reason?  For example, if the lab tests show contamination and the cord blood should not be saved, what happens?  Full refunds are typically only offered in situations where the bank provided staff to perform the collection service.
• Should the family ever need the cord blood, will the bank charge to release it or to ship it?

• What type of records do parents receive after storage?  
• Does your contract state that the storage fee is fixed, or may it increase later?  
• Does the bank reserve the right, in your contract, to change storage facilities?
• Does the bank operate their own storage facility, or is it provided by another laboratory? 
• What type of accreditation does the storage facility carry?  In most banks the cord blood is stored in the lab where it was processed, and the accreditation of the lab covers the storage conditions.
• What is the geographic location of the storage facility: Is it at risk for hurricanes, earthquakes, or other natural disasters?
• What type of back-up systems does the storage facility have in case of power failure?
• What type of security systems does the storage facility have? 

Childhood cancers are rare, and make up less than 1% of all cancers diagnosed each year¹.  It is even rarer for a child to require a stem cell transplant for cancer. In the US, the probability of a child having a stem cell transplant over the years from birth to age 20 is only 3 in 5000 or 0.06%².  This probability includes all 80+ of the diseases treated with cord blood.

Children that have a solid tumor have been treated with their own cord blood. This includes diagnoses such as neuroblastoma, medulloblastoma, and retinoblastoma. The very first case in the world where a child was given a transplant of her own cord blood happened in 1998 for a girl in Brazil who had neuroblastoma³.

Blood cancers such as the various forms of leukemia are the most common cancers in children. In the US, acute leukemia is one of the leading causes of death in children under 15 years of age⁴. Pediatric leukemia has been backtracked to birth^5,6. Researchers have discovered that in most cases of pediatric leukemia the genetic mutation which triggered the leukemia started in utero, before the child was even born, and is present in the cord blood. In fact, researchers are now studying cord blood to learn which children are at risk for pediatric leukemia and how it can be prevented^7,8.

Children should not be transplanted with their own cord blood if they have a pediatric blood cancer like leukemia, or a hereditary blood disorder like Thalassemia Major or Sickle Cell Anemia. All of these diseases have a genetic basis and they will be present in the child’s cord blood, so it is not safe to use that cord blood for transplant. Children with hematologic (blood) disease in need of transplant should receive stem cells from a donor. The ideal donor is a matched sibling donor.

References:

1. American Cancer Society - Key statistics for childhood cancers
2. Nietfeld JJ, Pasquini MC, Logan, BR, Verter, F, Horowitz MM. Lifetime Probabilities of Hematopoietic Stem Cell Transplantation in the U.S. BBMT 2008; 14(3)316–322. 
3. Ferreira E et al. 1999; Autologous cord blood transplantation. Bone Marrow Transplantation 24(9):1041. 
4. NIH Reporter. Backtracking Leukemia-Typical Somatic Alterations in Cord Blood at Single-cell Resolution. Project Number 1R01CA262012-01
5. Ford AM, Bennett CA, Price CM,  Bruin MCA, Van Wering ER, Greaves M. Fetal origins of the TEL-AML1 fusion gene in identical twins with leukemia. PNAS 1998; 95(8):4584-4588.
6. The Institute of Cancer Research (ICR). Pioneering scientist Mel Greaves is knighted after research to unveil cause of childhood leukaemia. News archive Published 2018-12-28
7. Marcotte EL, Spector LG, Mendes-de-Almeida DP, Nelson HH. The Prenatal Origin of Childhood Leukemia: Potential Applications for Epidemiology and Newborn Screening. Frontiers Pediatrics 2021; 9:639479.
8. Spector L. Studying Cord Blood to Prevent Childhood Leukemia. Parent's Guide to Cord Blood Foundation News Published 2022-07 

Yes, stem cell transplants with cord blood have been used to cure both children and adults with leukemia since the early 1990's. To date, there have been over 35,000 cord blood transplants world-wide, and most of them were for leukemias and other blood disorders (Ballen Verter Kurtzberg 2015). A study published in the New England Journal of Medicine (NEJM) in Sept 2016 compared cord blood transplants versus bone marrow transplants for leukemia patients. The two groups had comparable survival post-transplant, but the cord blood patients tended to live longer and most importantly the cord blood patients were less likely to relapse.

The important caveat is that children with leukemia or another blood disorder must receive a cord blood transplant from a donor, NOT their own cord blood. It turns out that when children and even adolescents develop leukemia, they were born with the genetic defect that triggered the leukemia... hence it is not safe to give them a transplant with their own cord blood because it probably carries the mutation for leukemia.

References:
Backtracking leukemia to birth: Gale KB et al. 1997; Proc Natl Acad Sci USA. 94(25):13950-4. PMID:9391133
Backtracking leukemia to birth: Janet D. Rowley 1998; Nature Medicine 4:150-1 PMID:9461182
Ballen KK, Verter F, Kurtzberg J 2015; Bone Marrow Transplantation 50(10):1271-8. doi:10.1038/bmt.2015.124
HealthDay article describing study in Sept 2016 NEJM: Cord Blood Transplants Show Promise in Leukemia Treatment
Filippo Milano, et al. 2016; NEJM 375:944-953. DOI:10.1056/NEJMoa1602074

Over the past decade, there have been over three dozen clinical trials treating cerebral palsy with stem cells. Several publications in peer-reviewed medical journals have demonstrated that cerebral palsy patients who received stem cells had a significant improvement compared to patients in control groups. We have created a spreadsheet that provides a detailed comparison of a few leading studies.

Despite these successful reports, no one understands the “mechanism of action” by which the stem cells provide a benefit.  Both cord blood stem cells and cord tissue MSC are known to suppress inflammation. Researchers at Duke have argued that a trace component of the cells in cord blood may enable re-myelination of neurons in the brain.

It is presumed that stem cell therapy probably also benefits other conditions that are similar to cerebral palsy, such as hypoxic ischemic encephalopathy. Bear in mind these benefits were proven for groups of patients and individual outcomes will vary. While some children have had dramatic improvements, for example Adriana or Asia, others have not improved at all.

On the basis of this evidence, Duke University has received permission from the FDA to offer expanded access to cord blood therapy for cerebral palsy and other pediatric brain injuries.  Any family that has a child with an acquired (not hereditary) brain injury, and has that child’s cord blood or a sibling’s cord blood in storage, is eligible for this therapy. Unfortunately, this program is so popular that the waiting list is over ten thousand children and growing.

There are many open questions about stem cell therapy for cerebral palsy that have not yet been answered by the existing research. It is not clear what type of stem cells are the “best” for this therapy, and there is also some debate over the optimum method of injecting the stem cells (intravenous versus intrathecal route of administration).

An important caveat for parents is that while stem cell therapy may improve a child’s cerebral palsy symptoms, it is not a cure all and does not replace other supports, such as physical and occupational therapy, tutoring, etc.

Please remember that the website of Parent’s Guide to Cord Blood Foundation is not a substitute for medical advice from a physician.

References:
Follow the links in the spreadsheet download

This topic is so somplex that it became too long for a FAQ post. We created a special page to cover Everything parents should know about stem cell therapy for autism. Most important, it explains the pros and cons of therapy with cord blood MNC versus cord tissue MSC.

The odds of using your baby's cord blood are the same as the probability that your baby or a close family member will have a disease that can be treated with cord blood.

Family cord blood banks tell parents that there are 80 diseases for which stem cell transplants are a standard treatment. That is a true statement, but it can be misleading. Most of those 80 diseases are rare among children. In the United States, the net probability that a child will need any type of stem cell transplant by age 20 is 3 in 5,000 or .06%. So the odds of use for transplant of a child are only 3 in 5000 for all of the 80 diseases combined!

When does cord blood stored in family banks have significant odds of use?

Family members: The graph on the left illustrates that, as people get older, rates of cancer increase, and the cumulative probability of having a stem cell transplant increases. In the United States, 1 in 217 people, or .46%, will have a stem cell transplant (not just need one, but have one) by age 70. Hence the cord blood that parents store from their baby might be of help to an immediate family member years from now. The cord blood is most likely to match first degree relatives: full siblings and parents.

Inherited disorders: The odds of use quoted for the average person in the United States do not apply to some families and do not apply at all in other countries.

For example, some parents want cord blood banking because they have many relatives with an auto-immune disorder like Multiple Sclerosis, and they know that stem cell transplants show promise for auto-immune diseases.

In Asian countries where the inherited blood disorder Thalassemia is prevalent, family cord blood banks are filling a public health need. Families can bank cord blood from a healthy baby to provide a sibling cord blood transplant to an older child with thalassemia. In Thailand some families are using assisted reproduction technology to conceive a matched savior sibling for an older child with Thalassemia.

In Africa, cord blood banks could fill a public health need by providing cord blood transplants for sickle cell disease and by storing stem cells that have a genetic mutation that can combat HIV.

Regenerative medicine: Parents are most likely to need their baby's cord blood to treat neurological disorders that are diagnosed in the first few years of life. These include autism, cerebral palsy, hypoxic-ischemic encephalopathy (HIE), apraxia, ataxia, hydrocephalus, in-utero stoke, traumatic brain injury, and similar conditions.

No one wants to imagine that their child might be born with a brain injury, but the reality is that cerebral palsy (CP) occurs in 2 of 1,000 full term births, and among premature births it is 10 times more common at 2 in 100 premies or 2% have cerebral palsy. Another relatively prevalent condition that may benefit from trials of cord blood therapy is autism spectrum disorders (ASD), which impact 1 in 44 US children as of 2018. As a public service, we have made available for download a spreadsheet of all clinical trials treating CP or ASD with cell therapy that were registered worldwide from 2017 to 2021.

Resource: Please see our page about Cord Blood Odds of Use, which gives specific numbers and has many references.
 

Some cord blood banks offer insurance as part of their standard services. This is one of the features parents might consider when shopping for a bank. Otherwise parents can purchase a separate policy. There are specialized insurance policies providing cord blood insurance to families that have previously stored their baby’s stem cells or are about to store stem cells for a baby they are expecting.

Some family banks provide cord blood insurance. In case your child gets sick and needs therapy, your national or personal health insurance may not cover all the expenses. The cord blood insurance provides extra security that the family will be able to afford a cord blood transplant or participation in a cord blood clinical trial.

Like cord blood, the umbilical cord tissue is a rich source of progenitor cells. However, they are a different population of cells from the ones in cord blood. While most of the stem cells in cord blood are blood-forming or hematopoietic stem cells (HSC), most of the cells in cord tissue are mesenchymal stromal cells (MSC).  The MSC are not distributed uniformly in the cord, but are mostly clustered around the walls of the blood vessels. The typical umbilical cord is estimated to hold 11 million MSC per gram of tissue.

While MSC can be found in many parts of the adult human body, MSC from the umbilical cord or UC-MSC are the most commonly used in clinical trials of regenerative medicine. It is well established that they can modulate the immune system and suppress inflammation.

Reference:
Schugar RC et al. 2009; Journal of Biomedicine and Biotechnology 2009:789526 (open access)

The tissue of the umbilical cord is rich in the primitive mesenchymal stromal cells (MSC). These cells can differentiate to bone, cartilage, and fat. More importantly, MSC send signals that modulate the patient's immune system and suppress inflammation. Infusions and injections of MSC are frequently used to treat orthopedic conditions, chronic pain, and auto-immune disorders. Clinical trials with MSC from cord tissue are available for many different disorders.

Reference:
Arnold Caplan PhD & Diego Correa, MD PhD. THE MSC: AN INJURY DRUGSTORE  Cell Stem Cell. 2011; 9(1):11–15.

The tissue of the umbilical cord and the placenta are rich sources of mesenchymal stromal cells (MSC). Currently MSC are the most popular form of cells that are being used in regenerative medicine and appear in many papers of published  research. MSC show great promise for treating a wide variety of auto-immune disorders and treating injuries to muscle or bone (heart disease, sports injuries). The MSC from birth sources, such as cord tissue and the placenta, grow faster than MSC from adult donors and have never been exposed to disease.

References:
Perinatal Stem Cells 2^nd edition 2013; book published by Wiley
Perinatal Stem Cells 3^rd edition 2018; book published by Elsevier

Therapies with mesenchymal stromal cells (MSC) from all sources are still under research, so the optimum dose has not been established for any diagnosis.

As of August 2020, only two papers have been published that summarized the MSC cell doses used in clinical trials.  The first paper, by Couto et al. 2019, looked at the first decade of clinical trials with MSC from umbilical cord tissue (UC-MSC), over the years 2007-2017, and collected trials from everywhere in the world. The trials were divided between those that gave local injections of UC-MSC versus systemic administration into the blood stream. Their figure 4 showing number of trials versus total cell dose is repeated below. Please note that there are breaks in the dose axis to accommodate the very wide range of cell doses.

Clinical applications that employ systemic administration tend to have higher cell doses. It is not possible to give large doses locally, such as injecting a single arthritic joint or injecting the spinal cord. The few trials that achieved high total cell dose with local administration were trials that gave multiple doses. In this graph, the median total dose of the studies with local administration was 18.75 million cells, while the median total dose of the systemic administration studies was 80 million cells.

A second paper published by Kabat et al. 2020 did the same type of analysis with a different data set of clinical trials. They looked at clinical trials with any type of MSC (from bone marrow, fat tissue, umbilical cord tissue, etc.), over the years 2004-2018, but only the trials registered in the United States. Within their data, they divided the route of administration into six different groups. They looked at route of administration versus trial phase, cell dose, and patient diagnosis (see their figures 5A – 5C). The most common method of delivery was intravenous (systemic) administration and the median dose by that route was 100 million cells.

References

• Couto PS, Shatirishvili G, Bersenev A, and Verter F. 2019; Regenerative Medicine 14(4):309-319. First decade of clinical trials and published studies with mesenchymal stromal cells from from umbilical cord tissue
• Kabat M, Bobkov I, Kumar S, Grumet M. 2020; Stem Cells Translational Medicine 9(1):17-27. Trends in mesenchymal stem cell clinical trials 2004‐2018: Is efficacy optimal in a narrow dose range?

Within the United States, some states have licensing requirements for cord blood banks. These requirements apply to any cord blood bank that operates within the state, accepts collections from the state, or distributes cord blood units to the state.

If you are a parent who lives in a state with a licensing requirement, then only those cord blood banks that are licensed by your state can legally do business with you. Licenses are required for the states of California, Illinois, Maryland, New Jersey, and New York.

The states California and New York have the strictest licensing standards. These states have inspectors that visit cord blood banks to confirm compliance with the licensing requirements.

These rumors are totally false. In fact, our 2015 Cord Blood Industry Report found that the majority of family cord blood banks in the United States and Canada are processing cord blood manually with hespan. Hespan or HES is a brand name for the chemical hydroxyethyl starch. It is commonly used in most laboratories that handle blood.

The source of the rumors about hespan is the following: Up until recently, it was a standard procedure in emergency rooms to give a large infusion of hespan to patients who were going into shock from loss of blood pressure. The idea was to briefly replace their blood volume with hespan while the ER doctors were rushing to fix whatever problem had caused a rapid loss of blood pressure, and while waiting for a matching transfusion from the nearest blood bank. However, retrospective studies have recently found that patients who survived this experience were likely to develop kidney failure later. Hence, doctors now realize that infusing large volumes of hespan intravenously is not safe. However, the use of small volumes of hespan in cord blood processing is still perfectly safe.

Reference:
Zarychanski R. et al. 2013; JAMA 309(7):678-88. doi:10.1001/jama.2013.430.