Frequently Asked Questions

Topics



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Do I need to store the cord blood in the country where I plan to use it?
No.  First, you must store blood in a lab that is permitted by the regulations of the country where you will give birth.  Second, you should store cord blood in a lab that can receive and process the collection within 48 hours of birth.  After cord blood is collected at birth, the stem cells start to die while the blood is waiting to be processed and frozen.  The quicker it gets to the lab the better.  By comparison, if you ever need the cord blood for therapy, it will be shipped in a vessel that keeps it frozen.  When cord blood is released for therapy can travel to the other side of the world with no loss of viability, because it travels frozen.  It is only thawed at the clinic where it will be used. 
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How do I pick a public bank?
You rarely get to pick a public bank.  If you are having your baby at a hospital that accepts donations, then you are one of the lucky few.  The only way you could have a choice in the matter is if you are choosing a mail in donation program.
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How does the Institute of Medicine influence cord blood education?
Congress commissioned an Institute of Medicine study on the ideal structure of a national cord blood program.  Based on the IoM report, Congress passed the Stem Cell Therapeutic and Research Act of 2005 that was signed into law 20 Dec. 2005.  The key language regarding education is the requirement: Information provided to the maternal donor regard(s) all of her medically appropriate cord blood options.  ie: Education of expectant parents and Informed Consent of maternal donors should cover all options, not just donation.
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How is cord blood collected?
It literally only takes minutes to save the stem cells in cord blood.  Once the cord is clamped, the cord is wiped with antiseptic and a needle is inserted into one of the veins in the umbilical cord to withdraw a few ounces of blood.

There are two methods of collection in common use.  One is to hang a blood bag lower than the mother and let gravity draw blood down the tube into the bag.  This method is used in most countries of the world, because it has the fewest steps, and therefore the fewest opportunities for mistakes or contamination.

The second method is to actively draw the blood out, just like when a person has a blood draw for a medical test.  The draw can be done with a standard syringe or with a bulb in the bag tubing that creates suction.  Studies have shown that actively drawing the blood will collect a larger volume faster.
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How is education from the Parent's Guide to Cord Blood unique?
We are the only organization in the United States providing cord blood education materials that offer balanced information about both donation and family storage, and are approved by an Advisory Panel of leading Scientists and Medical Doctors.
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How is the website of the Parent's Guide to Cord Blood unique?
  • Only searchable map of US donation locations.
  • Only worldwide directory of private/family cord blood banks that is actively maintained.
  • Only website offering a Compare Banks tool that is not a marketing feature of one of the Banks.
  • Only list of "diseases treated" that differentiates between standard vs. experimental therapy, and whether the treatment uses stem cells from the patient vs. a donor. 
  • Only cord blood web site that is accredited by Health on the Net (HON) standards for accuracy and ethics.
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How much blood and stem cells does a typical umbilical cord hold?
The median size of cord blood collections in family banks is 60mL or 2 ounces.  That small volume of liquid 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 in their umbilical cord blood.   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 90-100 mL or 3 ounces.

Reference:
Sun, JJ et al., Transfusion Sept. 2010; 50(9):1980-1987
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If I banked privately for one child, do I need to do it for additional children?
All the reasons that you banked for the first child are still valid for additional children. 
1. If you want the baby to have the option of using his/her own cells, then you need to bank them. 
2. If you are banking to cover siblings, then the ability to use cord blood from one child for another depends on whether they have matching HLA type.  Two full siblings have a 25% chance of being a perfect match, a 50% chance of being a half match, and a 25% chance of not matching at all.  For a cord blood transplant, donor and patient must match at 4 out of 6 (67%) HLA types.  The more siblings with banked cord blood, the more chance that they cover each other for possible transplants or other therapies for which sibling stem cells are accepted.

References:
Odds of sibling match are based on haplotype inheritence: that the child will receive 3 HLA types as a group from each parent.
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Processing: How is cord blood processed before storage?
The three main components of cord blood, like any blood collection, can be separated by weight:  the heaviest layer is the red blood cells (RBC), the lightest is the plasma (a clear white liquid), and in the middle is a pinkish layer called the "buffy coat" which contains the white blood cells (WBC), including stem cells.  When banks process the cord blood, the final separated component that goes into storage is the buffy coat, even though only about 1% of the cells are actually stem cells.  There is no procedure to separate out the stem cells alone.

The vast majority of blood processing methods rely on the different density of the three main blood components.  They can be separated by sedimentation, or by centrifuge, or by a combination of the two techniques.  The procedure can be performed manually by trained technicians or by automated machine.
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Processing: Must cord blood be processed before storage?
The earliest cord blood transplants were performed with whole cord blood.  Thus, it is not absolutely necessary to process cord blood in order to save patient lives.  There has never been a prospective randomized trial to compare transplant patient outcomes with cord blood that had been stored whole versus processed.

Most cord blood banks, both public and private, now process cord blood to remove both the plasma and the red cells, and cryo-preserve the remaining buffy coat holding stem cells.  Some banks also save the removed red cells and plasma in companion storage.  Some banks save a sample of maternal blood.

The removal of plasma is also called volume reduction.  The volume reduction enables more collection units to fit in a freezer and requires less cryogenic nitrogen per unit.

Also, the majority of banks remove red blood cells prior to freezing, primarily because these cells often burst during freezing and release iron from hemoglobin that can be toxic.  The alternate to removing the red cells before freezing is to wash any broken cells out of the collection upon thaw.  Removing the red cells also removes the donor's blood type (the ABO and Rh types).  When cord blood goes from a donor to a patient for a transplant, the donor and patient can be compatible on all the HLA types used for transplant matching and still have incompatible red blood types.

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Recommendations from Parent's Guide to Cord Blood
  • Educate expectant parents about all their options for cord blood (Education)
  • Choose a family bank that meets all your national and local regulations, plus has been inspected by an accreditation agency (Lab Standards)
  • Choose a family bank that uses a specialized courier to transport cord blood (Find a Family Bank), or in some countries the family can hire a specialized courier directly (Shipping & Handling).
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What are the most important considerations in picking a family bank?
1. Nationality - You must follow the national regulations of the country where you will give birth.
2. Travel conditions - It is best to pick a bank that can receive and process the cord blood within 48 hours of birth.  It is also best for the cord blood to be shipped in a transport container that will maintain it at close to "room temperature". 
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What fraction of cord blood donations get accepted?
Between a half and three quarters of donations are discarded.  The primary reason is that the collection volume is too small.  Public banks will only save a collection that is big enough to transplant a large child or small adult.
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What is the allowed time window for shipping cord blood to the lab?
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. 


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What is the benefit of HON accreditation of the Parent's Guide to Cord Blood website?
Health on the Net Foundation (HON) is an international non-profit under the United Nations that is dedicated to inspecting and accrediting medical websites for accurate and ethical content.  Websites accredited under the HON code are committed to abide by these 8 principles:

  1. Authority - Give qualifications of authors
  2. Complementarity - Information to support, not replace physician
  3. Confidentiality - Respect the privacy of site users
  4. Attribution - Cite the sources and dates of medical information
  5. Justifiability - Justification of claims / balanced and objective claims
  6. Transparency - Accessibility, provide valid contact details
  7. Financial disclosure - Provide details of funding
  8. Advertising - Clearly distinguish advertising from editorial content

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What is the role of the Parent's Guide to Cord Blood Advisory Panel?
Our panel of scientific and medical experts reviews and approves our educational brochures.  Each member may assist with development of new web content in his or her area of expertise.  The panel is also on-call to answer difficult questions from readers.
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What questions should parents ask a Family Bank about collecting cord blood?
  • What instructional tools are provided for the physician and delivery staff?
  • Will the cord blood company actively contact the labor and delivery staff for you -- or are parents responsible for keeping them informed and coordinated?  
  •  What collection method do they use: gravity drip or blood draw?
  • Is the collection blood bag sterile, both inside and out, so that it can be used in the operating room for a C-section?
  • Do they provide the option of collecting additional stem cells from the placenta or tissue of the umbilical cord?
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What questions should parents ask a Family Bank about Company Stability?
  • Is the family cord blood bank a publicly-held or privately-held company? 
  • Is the company affiliated with a hospital or research institution? 
  • Is the company involved in bio-technology research and development?
  • What other medical services does the company perform?
  • 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 the lab inventory of cord blood collections, both public and private?  This speaks to their staff's experience with storing cord blood.
  • How many cord blood collections has the bank released from their own lab for therapy?  This speaks to their staff's experience with releasing cord blood.
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What questions should parents ask a Family Bank about Laboratory Standards?
  • Is the cord blood laboratory accredited by an agency that has specific standards for cord blood banks and conducts inspections? (ex: AABB, FACT, ISO)
  • Some US states license cord blood banks (CA, MD, NJ, NY): Do they operate in those states?  Note that the California Biologics License is based on AABB accreditation, but lags behind the latest AABB updates.
  • Does the lab process cord blood around the clock, or only on selected shifts?
  • What tests does the lab perform on maternal blood?  
  • What tests does the lab perform for infectious disease markers?
  • What tests does the lab perform for contamination?
  • Does the lab ever reject cord blood collections on the basis of the tests of maternal blood, infectious diseases, or contamination? 
  • Does the lab maintain a "quarantine tank" for the storage of blood that might be able to transmit an infection?
  • What tests does the lab perform to measure the stem cell count of the processed cord blood and the stem cell viability?
  • Does the lab/bank inform parents, prior to storage, if the collection is too small for a transplant, and give them the option not to save it?
  • Does the lab/bank offer parents a refund if the cord blood collection has certain problems (contamination, low volume)?  These refunds are typically only offered if the bank performed the collection as part of their service.
  • What information will parents receive in the final report about their stored cord blood?
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What questions should parents ask a Family Bank about Prices?
  • Is the enrollment fee charged once per family, or for each birth?
  • Is the first year of storage included in the processing fee?
  • Is the storage fee guaranteed fixed?
  • Are there any coupons currently available?  Most banks are constantly running a "special limited time offer".
  • Are there any professional discounts?  Most banks offer discounts to medical professionals and military personnel.  Some banks have discounts for first responders or students.  It pays to shop for these deals.
  • 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, check that the bank does not charge to release it.
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What questions should parents ask a Family Bank about Shipping & Handling?
  • Is the cost of shipping included in the contract? 
  • Does the shipping company offer bed-side pick-up?  
  • On weekends, are the laboratory staff in-house or on-call?
  • Does the bank guarantee to get the blood to the lab and processed within a certain time window?
  • Does the shipping container have a temperature logger?
  • If the bank uses a courier, does the courier have possession of the cord blood throughout transit?  (ie: Does the courier sub-contract to another shipping company that is not a medical courier)? 
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Who is able to donate cord blood?
In theory, any expectant mother who passes the medical screening is eligible to donate.  In practice, the biggest hurdle faced by families who wish to donate is finding a bank to accept their donation.  There are only about 200 hospitals in the US that collect cord blood donations from births, and most of them require you to register for donation weeks ahead of the birth.  The handful of programs that accept mail-in donations are opening this opportunity to the rest of the American public.
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Why is it important to choose a Family Bank that is accredited?
The Parent's Guide to Cord Blood Foundation recommends that parents select a Family Bank whose laboratory has been inspected and accredited by an accreditation agency specific to cord blood banking, as 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 (Examples: Germany, Israel).  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 BLA License 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.
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Why is it important to ship cord blood with a special courier?
The Parent's Guide to Cord Blood Foundation recommends shipping with a courier that has a division specializing in "Life Sciences" transport.  This helps to insure that your critical shipment is not misplaced, arrives promptly, and is maintained within the acceptable temperature range during transport from the hospital to the lab.

The first priority for parents to consider is the cord blood shipping time: Once the cord blood is harvested, the blood cells and stem cells gradually begin to die.  Public cord blood banks set a limit of 48 hours on the time between birth and processing the blood for cryogenic storage.  It would be a "best practice" if family banks also followed the 48 hour window.

The second priority for parents to consider is the cord blood shipping temperature:  The standard procedure for transporting fresh cord blood is to keep it within an ambient temperature range of 15 °C (59 °F) to 25 °C (77 °F).  Priority shipping services may guarantee the arrival time, but not the temperature conditions during transit.  The cord blood might get too hot or too cold while sitting in the back of a truck, on a loading dock, or in the cargo hold of an airplane.  A specialty courier with Life Sciences expertise will carry the cord blood in a controlled environment.

Parents can improve the survival of their child's cells during transit to the cord blood laboratory by selecting a family bank that provides a well insulated shipping container and that provides a specialty courier who maintains the shipment within the desired temperature range.  In many countries it is standard practice for the shipping container to have a temperature logger.

In the United States, the post 9/11 security requirements of the Transportation Security Administration (TSA) require that specialty couriers can only offer cord blood shipping through those cord blood banks that are registered with the TSA as a "Known Shipper".  Before 9/11, specialty couriers could market their services directly to consumers, and in some countries this is still possible.  Parents should check if a Family Bank offers specialty courier services before they sign a contract. 

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Will my delivery hospital allow me to use any family bank?
In the US, the answer to this question is almost always YES.  However... a handful of hospitals have signed exclusive contracts requiring their patients to use certain family banks, so it is best to check in advance. 

Those hospitals who have made exclusive partnerships will argue that it improves their level of care, because their staff train with and stock the collection kits for the banks they have approved.  The hospital probably has a financial incentive too.  However, for parents it means a lack of consumer choice.
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Are related donors better for transplants?
The overall answer is yes, but this is a complex topic.

The two important measures of patient outcome are: long-term survival, and the  impact on quality of life from graft-versus-host disease (GvHD). Sibling donors tend to trigger less GvHD.  Also, sibling donors are available faster than searching for an unrelated donor, and patients have better survival when they go to transplant faster after diagnosis.

The exact comparison of outcome between sibling or unrelated donor varies with the patient diagnosis.  The NMDP website has a page on this, with numerous references.  For many cancers the outcomes are comparable, although sibling donors have a slight edge. The largest study was by Weisdorf et al. 2002, for over 2900 patients with CML leukemia.  When correcting for all other factors, the survival with sibling donor vs unrelated donor was 68% vs. 61%. Sibling donors show a significant improvement for pediatric cord blood transplants of hereditary disorders.  The European Blood and Marrow Transplantation Group (EBMT) reported 3 year survival rates of 95% from a sibling donor vs. 61% from an unrelated donor.

References:
Weisdorf, D.J. et al. Blood 2002; 99:1971-1977.
Bizzetto, R. et al. (EBMT) Haematologica 2011; 96(01):134-141

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Once we have stored cord blood for our family, how long should we keep it?
Indefinitely.  From an economic perspective, it does not make sense to invest in the up-front processing fee and pay for years of annual storage, and then throw out the investment.  That would be like buying life insurance and then cancelling it because you have not died yet.  Especially given that the probability of some one in the immediate family needing a transplant increases with age.  Even if the cord blood collection was small, and the child becomes too large to use it for a transplant, it could still be enough cells for a regenerative medicine therapy. The science of cryobiology tells us that cells which are cryogenically preserved remain viable for decades.  It has been confirmed that cord blood stem cells were still viable after being frozen 23+ years.

References:
Broxmeyer, H.E. Cell Stem Cell 2010; 6(1):21-24
Mazur, P. Science 1970; 168(3934):939-949
Nietfeld, J.J. et al. BBMT 2008; 14:316-322
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What are the most important things to do when collecting cord blood?
1. Read the instructions on the kit!  Too many healthcare providers think that they don't need to read and follow instructions.
2.  Sterilize before every needle stick.  When in doubt, sterilize again!
3. Volume, volume, volume.  You want to "milk the cord" for as much blood as possible.  If the blood vessel you are using stops working, try another or move upstream, but sterilize first.
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How much cord blood is needed for a transplant?
The crucial thing is not the volume of the cord blood collection, but the number of stem cells it contains. Transplant doctors develop recommendations based on the Total Nucleated Cell count, or TNC, because it is the easiest measure to reproduce between different labs.    For treating cancer, the transplant dose should be at least 25 million TNC per kilogram of patient body weight (1 kilogram equals 2.2 pounds).  The average cord blood collection holds 8.6 million TNC per mL.  Thus, the optimal transplant dose requires harvesting:
1.3 mL of cord blood for every pound of patient weight, -or-
2.9 mL of cord blood for every kg of patient weight

However, as more transplant centers are adopting the practice of giving adult  patients "double cord blood transplants" with two cord blood units, it is less critical for both units to have adequate cell dose.

References:
Reed, W et al., Blood 2003;101(1):351
Barker, JN et al., Blood 2005;105:1343-1347
Eapen, M et al. Lancet 2007;369:1947-54
Rocha & Gluckman Brit. J. Haematology 2008;147:262-274
Delaney, C et al., Brit. J. Haematology 2009;147:207-216
Michallet et al. 2010 Blood 2010;116:Abstract#361
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What questions should parents ask a Family Bank about the Storage Facility?
  • 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 or other certifications 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? 
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If I donate my baby's cord blood, will that child have free access to cord blood for a transplant?
No.  When a mother signs the Informed Consent to donate cord blood, she gives up any guaranteed access to that blood.  The blood may not be banked, and if it is banked, it may be released to some one else.  There have been cases where families needed their child's cord blood and got it back from a public bank, but it is important to realize there are no guarantees of access to donated cord blood.  Cord blood donors also do not receive guarantees of 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.
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What is delayed cord clamping?
Some people feel that the blood in the umbilical cord should be allowed to flow into the baby and that the cord should not be clamped while it is still pulsing.  Medical studies have shown that, particularly in parts of the world with poor infant health care, delayed cord clamping can help protect the baby from anemia (low blood counts) during the first 6 months of life.  However, a prolonged delay will allow the blood in the cord to clot, and the opportunity to collect the blood for stem cells will be lost.  Therefore, if clamping is delayed, it should not be more than two minutes.

References:
Hutton, EK & Hassan, ES, JAMA 2007; 297:1241-1252
van Rheenen, P et al., Tropical Med. and Internal Health 2007; 12(5):603-616
Abalos E., 2009; The World Health Organization Reproductive Health Library
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What is HLA Type and how is it used?
The term "HLA" is short for Human Leukocyte Antigens, and these are proteins in the immune system that determine whether a patient will react against a donor transplant.  A very good basic tutorial about HLA types is on the Stanford Website, and the national Be The Match program (aka NMDP) has more info on the role of HLA type in transplants of stem cells from bone marrow or cord blood.

Briefly, there are 6 HLA types that are important for stem cell transplants: in a bone marrow transplant the patient and donor must match at all 6 (100% match), whereas a cord blood transplant is just as effective at curing patients with only a 4 out of 6 match (67% match) between donor and patient.  This is the reason that donations to the national cord blood inventory managed by NMDP are so important to help patients who come from minority or mixed racial backgrounds.

The HLA type of cord blood is always measured by public banks, and then the type is listed on a registry that can be searched by patients seeking a transplant.  Family banks typically do not measure the HLA type at the time of banking, because it is an expensive lab test and and can always be checked later from a testing segment of the stored cells.
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What are TNC, MNC, CD34+, and CFU, and why should I care?
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.