America's first private cord blood bank using advanced cryopreservation technology to  preserve your baby's cord blood stem cells


 


  1. What is umbilical cord blood (UCB) banking?
  2. What is UCB?
  3. What are stem cells?
  4. Are stem cells found only in UCB?
  5. Is cord blood collection risky or painful?
  6. What makes UCB stem cells so unique?
  7. What are the benefits of UCB transplantation?
  8. Who can use the UCB stem cells?
  9. How are stem cells administered when needed?
  10. How do the UCB stem cells work?
  11. What are the different types of UCB stem cell transplants?
  12. How is cord blood collected?
  13. Does MiraCell's collection method (kit) use the collection bag or syringes?
  14. How much cord blood is collected?
  15. What is Graft Versus Host Disease (GVHD)?
  16. How are these stem cells used in medicine today?
  17. How will UCB stem cells be used in the future?
  18. What is the history of UCB stem cell transplantation?
  19. Which families choose to store their baby's UCB?
  20. When do I need to enroll with MiraCell to have my baby's UCB saved?
  21. What are the chances my family will need to use these UCB stem cells?
  22. What needs to be done if the stored UCB stem cells are needed?
  23. Is their a charge to retrieve the stored UCB stem cells?
  24. Who is responsible for informing the necessary people about the collection?
  25. How does MiraCell store my baby's stem cells, and is it considered a safe method of storage?
  26. How long can my baby's UCB stem cells be stored?
  27. How does MiraCell receive my baby's UCB and what happens with it next?
  28. What happens to the UCB during processing at MiraCell?
  29. Is MiraCell's laboratory registered, and do they have certification?
  30. Can Thalassemia be treated with Umbilical Cord Blood (UCB) Stem Cells?

1) WHAT IS UMBILICAL CORD BLOOD (UCB) BANKING?
UCB banking is a once in a lifetime opportunity that allows your family to save or bank UCB stem cells following your baby’s delivery. There are two basic types of umbilical cord blood banks, private banks and public banks. When you save or bank UCB with a private bank, the UCB stem cells are uniquely reserved for your family, and no one else has access to them. There are families who have an identified medical need for stem cell therapy and naturally request that their baby’s stem cells be privately banked. These families, with an identified need, may use these stem cells for their immediate and or possibly extended family member’s use. Private Banks are sometimes known as “family banks” and charge a fee for this service. Parents consider this private banking opportunity as a type of health insurance, or simply a sound biological investment providing comfort and confidence to their family. With private banking, your family retains the right to decide how and when these cells can be used; thus maintaining total control throughout their storage.

Public banks are usually government funded or subsidized, not-for-profit and registered with a National Registry. When UCB is donated to a public bank, the stem cells are not specifically reserved for your family’s needs or use. The UCB stem cells are made available for the general public’s use, or used in research. Between 60 to 70% of the donated UCB samples are rejected as they do not meet strict screening guidelines. Collections may be rejected or discarded for any of the following reasons: maternal infectious disease history; maternal travel outside of the US to certain countries; insufficient UCB unit volume; “at risk” behaviors, such as: illicit drug use, homosexual health history or a history of sexually transmitted disease; or tattoos (and some body piercings) received within 12 months of the collection. Each year thousands of people are diagnosed with diseases that can be treated with stem cell transplantation, and it is estimated that 70% of these people are unable to find a donor through the public registries. It is especially difficult for African Americans, Hispanics, Native Americans, as well as other minorities and ethnic groups to match with these unrelated donors. Some families feel that this makes an argument for public banking, while other families feel that this same information makes a more compelling argument for private banking. Only your family can make this important decision.
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2) WHAT IS UCB?
UCB is the blood that remains in the baby’s umbilical cord and placenta after the delivery. In most cases, this blood is typically discarded or possibly sold for research after the birth of the baby. This particular blood is quite unique in that it contains a large number of stem cells.
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3) WHAT ARE STEM CELLS?
A stem cell is a master cell, capable of dividing or reproducing into other types of cells: red blood cells, (which carry oxygen throughout your body); white blood cells, (which fight infection), and platelets, (which aid in blood clotting). These master cells are the building blocks of the blood and immune system.
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4) ARE STEM CELLS FOUND ONLY IN UCB?
UCB is only one of three sources of hematopoietic stem cells; the other two sources being bone marrow and peripheral blood. The stem cells found in cord blood have several significant advantages over the stem cells found in bone marrow and those that are found in peripheral blood. UCB contains 10 to 20% more stem cells than bone marrow. UCB stem cells are 8 to 10 times more proliferative (they increase more rapidly) than those from bone marrow. UCB stem cells have a greater chance of matching other family members because they are “immunologically immature”, or naļve, and they have a higher rate of engraftment. UCB stem cells are more “pure”, as they are cryopreserved shortly after birth and therefore do not experience “aging” or different viral/disease “exposure” as do more mature stem cells from peripheral blood or bone marrow (those generally collected from adults).
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5) IS CORD BLOOD COLLECTION RISKY OR PAINFUL?
Absolutely not! The cord blood collection is done after the baby’s delivery, and after the umbilical cord has been clamped and cut. The collection can be done after a vaginal or a C-Section delivery; and can be done with the placenta in utero (still inside the mother, attached to the uterine wall), or ex utero (placenta outside of the mother, no longer attached to the uterine wall). There is absolutely no pain or risk involved during the collection for the mother or baby. The umbilical cord and placenta actually have no sensation or feeling – much like hair or fingernails.
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6) WHAT MAKES UCB STEM CELLS SO UNIQUE ?
If collected and stored after birth, UCB stem cells are available when needed, (2 to 4 weeks for processing) versus an average 3 to 6 month search for matching bone marrow stem cells. This wait may be critical to a recipient’s survival. There is absolutely no pain or risk to anyone during the collection of UCB stem cells, versus that experienced during bone biopsy and general anesthesia when bone marrow stem cells are collected. UCB collection is also much less expensive because of these drastically different procurement procedures. It requires less frequent hospitalizations due to fewer post transfusion complications (Graft Versus Host Disease [GVHD], and a lower risk of infection, such as CMV, EBV, HIV, Hepatitis B, and possibly HHV-6), thereby providing for a higher quality of life. Other advantages that UCB stem cells have over bone marrow and peripheral stem cells are:

  • a higher rate of engraftment (acceptance by the body) in children. A smaller amount of UCB stem cells are needed than other sources of stem cells, as they contain a higher number of progenitor cells (CD34+ cells) and they are more proliferative (8 to 10 times).
  • greater tolerance of tissue mismatches; (less than perfect HLA match required; possibly as low as 3 or 4 to 6 HLA mismatch tolerated with UCB stem cells, as opposed to a 6 of 6 HLA match needed for bone marrow transplants).
  • a lower incidence and severity of acute and chronic GVHD.
  • provision of a 100% perfect match for the donating baby; at least a 25% or greater chance of matching a sibling, and potentially a match for parents, grandparents and other blood relatives!
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7) WHAT ARE THE BENEFITS OF UCB TRANSPLANTATION?

  • Easily obtained after delivery without any risks to mother or baby
  • Can be stored for personal use (private banking), or donated for others to use (public banking)
  • More accessible for ethnic minorities for whom bone marrow donors are often times difficult to locate
  • Infectious disease contamination is less of a problem
  • Less stringent HLA-matching required for transplantation use
  • Less GVHD and side effects after transplantation
  • Biological insurance in an inexpensive form
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8) WHO CAN USE THE UCB STEM CELLS?
If your family chooses to privately bank your baby’s UCB, you will have timely access to those stem cells. At present, there is no established centralized registry for publicly donated UCB units, thereby lengthening the search time necessary to find a suitable transplant match. Private UCB banking recognizes this search time and assures immediate availability of your baby’s stem cells. This ensures a 100% HLA (tissue) match for the donor baby; and at least a 25% chance for a sibling match, (as UCB stem cells need only between a 3 or 4 to 6 HLA match). There is even a potential use for parents, grandparents, or other blood relatives with an adequate HLA match. At the present time we do know that there are certain diseases that cannot be treated with one’s own stem cells. If your family chooses to have the stem cells publicly banked, these cells are made available to anyone in need and not “reserved” for your family’s possible future needs.
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9) HOW ARE STEM CELLS ADMINISTERED WHEN NEEDED?
Most commonly the stem cells are infused intravenously through a central catheter, much the same way IV fluids are administered. Most stem cell recipients (transplant recipients) will have a central line, or central catheter, already in place from their chemotherapy. Administration of the stem cells through this catheter is the transfusion, or transplantation of stem cells. Stem cells have also been delivered by direct injection into the “target” site; as done with a patient who had experienced a heart attack. The heart muscle was actually noted to generate healthy muscle cells after using this alternative method of administration. Although the direct injection method is much less commonly used at present, it may gain popularity as research and technology advance, as a smaller amount of stem cells are required for effectiveness.
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10) HOW DO THE UCB STEM CELLS WORK?
They actually work in the same fashion as bone marrow stem cells, but have some advantages as noted previously. Once the stem cells have been administered, these stem cells migrate into the bone marrow and begin producing new blood cells and supporting the weakened immune system. UCB stem cells are especially valuable when these systems have been damaged by radiation or chemotherapy.
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11) WHAT ARE THE DIFFERENT TYPES OF UCB STEM CELL TRANSPLANTS?
There are two basic types of stem cell transplants:

  • Autologous an autologous transplant uses your own individual stem cells that have been previously collected and banked. An example of this would be a child receiving their own UCB stem cells that had been collected after birth and stored with a private bank.
  • Allogeneic allogeneic stem cells for transplantation can be acquired from three different sources: a blood relative, or “related donor”; or an “unrelated donor”, such as stem cells donated publicly and registered with the National Marrow Donor Program (NMDP); or donated UCB from a public cord blood registry.
    • Syngeneic a syngeneic transplant is a form of allogeneic transplant and uses stem cells that have been collected from an identical twin.
    • Mini-transplantation a type of allogeneic transplantation, it is sometimes called the “mixed chimerism transplant”. These patients often display a “mixed” HLA type; known as chimerism. The goal of this new therapy is to give multiple mismatched units of UCB stem cells to obtain a high enough stem cell count to ensure rapid engraftment in an adult. The end goal is to produce a harmonious coexistence between the donor and the recipient’s immune systems. It is a relatively new transplant therapy and is being used to treat various high risk diseases.
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12) HOW IS CORD BLOOD COLLECTED ?
Immediately after delivery of your baby, your delivery team (usually led by your delivering physician or midwife) will collect the UCB that remains in the placenta and umbilical cord using MiraCell’s collection kit. After sterile preparation of a four inch segment of the umbilical cord, the collection needle is inserted into the vein of this prepared area. A general yield between 70 and 100 mls (approximately 5 to 7 tablespoons) is collected by gravity flow, with the entire process taking approximately 3 to 5 minutes. (Four 6ml vials of maternal blood will be drawn upon mother’s arrival to the delivery unit, usually with her regular hospital admission labs). Following the UCB collection, the bag is secured, labeled and transported back to MiraCell (along with maternal blood) for processing. There is no pain involved with the UCB collection procedure, as the umbilical cord has no sensation or feeling.
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13) DOES MIRACELL'S COLLECTION METHOD (KIT) USE THE BLOOD COLLECTION BAG OR SYRINGES?
With the collection process almost solely being handled by delivering physicians and midwives, MiraCell’s decision to exclusively use the collection bag method, rather than the syringe method, was one directed by our healthcare staff. MiraCell felt the issue of collection method of utmost importance, and therefore consulted with those professionals actually using these collection tools, for their professional preferences. Ease of use, and less chance of blood contamination with resulting infection, is the two most consistent reasons healthcare professionals preferred the collection bag. (The collection bag is a closed system, and reduces the number of times the blood must be transferred, both after collection, and again during processing). As a CLIA certified and pending AABB accredited laboratory, MiraCell is interested in meeting, if not exceeding, those standards and guidelines utilized by recognized industry leaders. The National Institute of Health and the International and American Red Cross are two such leaders utilizing the collection bag method.
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14) HOW MUCH CORD BLOOD IS COLLECTED?
Generally between 70 and 100 mls (5 to 7 tablespoons) is collected. The amount collected is dependent upon several contributing factors:

  • The available amount of blood remaining in the umbilical cord and placenta after the delivery. This amount can be affected by the birth order and/or multiple births, such as twins, triplets, etc… We know that there is more cord blood available with your first baby’s delivery than with subsequent deliveries, and that multiple births reduce the total amount of cord blood obtainable from each cord. It is also thought that the total volume of cord blood is greater when the collection is done with the placenta in utero, as opposed to ex utero.
  • The use of adequate collection supplies by the health care team.
  • The technique of the person performing the UCB collection.

MiraCell firmly believes that we can increase the amount of blood collected by positively impacting these last two areas (#2 and #3 above). Before your delivery, MiraCell provides clinical and educational training to any hospital or medical personnel using our collection kit. The end result is that the greatest possible amount of blood that could be collected will be collected for your family.
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15) WHAT IS GRAFT VERSUS HOST DISEASE (GVHD)?
This is one of the most common and severe (sometimes fatal) reactions following a transplant. GVHD may occur in either an acute or chronic form, and occurs when the donor’s white blood cells attack the recipient’s tissue because the donor’s lymphocytes recognize the tissues as foreign (if the “HLA” match is not perfect). The skin, liver and gastrointestinal tract are most susceptible to attack from the donor’s white cells. UCB stem cell transplants in children have a noticeably lower incidence of GVHD.
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16) HOW ARE THESE STEM CELLS USED IN MEDICINE TODAY?
Stem cell transplants are most commonly used in three different treatment modalities: 1) treatment of blood cancers, such as Lymphoma, Leukemia, Myeloma and Anemia; 2) treatment of solid tumor cancers, such as, Neuroblastoma, Breast and Lung; and 3) treatment of genetic disorders, such as, Sickle Cell Anemia and Thalassemia. When stem cells are used for the treatment of blood cancers, generally patients have been treated with chemotherapy and/or radiation to destroy their cancer cells. Stem cells are then given (or transplanted) to regenerate the patient’s blood and immune systems. Whether the bone marrow has been damaged by medical treatment such as, chemotherapy or radiation; or the disease itself, a stem cell transplant usually becomes necessary. Stem cells have been used in treatment therapy for 50 to 60 different cancers, genetic disorders and immune deficiencies. To date, approximately two-thirds of the UCB stem cell transplants have been for treatment of malignant conditions and the other one-third for a variety of genetic blood disorders. Some of the most familiar uses being for: Leukemia, Aplastic Anemia, Hodgkin’s Disease, Non-Hodgkin’s Lymphoma, Multiple Myeloma, Neuroblastoma, Fanconi’s Anemia, Lupus, and Severe Combined Immunodeficiency. Although cord blood has only most recently received greater media attention, its use instead of bone marrow transplants has been increasing steadily due to the documented advantages and demonstrated successes.
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17) HOW WILL UCB STEM CELLS BE USED IN THE FUTURE?
The uses for stem cells in different treatment therapies are increasing every day. In addition to the already documented 80 to 90 present uses for stem cells, researchers are anticipating their use in treatments for; diabetes, heart disease, stroke, and muscular dystrophy. Repair of spinal cord injuries, blood vessel growth, treatment of Alzheimer’s and Parkinson’s disease are other areas of anticipated use. As the causes of more diseases are discovered, it is projected by researchers that the uses for cord blood stem cell transplantation will undoubtedly increase. “Given the enormous promise of stem cells to the development of new therapies for the most devastating diseases, when a readily available source of stem cells is identified, it is not too unrealistic to say that this research will revolutionize the practice of medicine and improve the quality and length of life.” National Institutes of Health, May, 2000
NOTE: We are not referring to embryonic stem cells.
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18) WHAT IS THE HISTORY OF UCB STEM CELL TRANSPLANTATION?
In 1988, the first cord blood transplantation was performed in Paris, France on a five year old boy with Fanconi’s Syndrome, or Fanconi’s Anemia, using his sister’s UCB stem cells. To date he remains disease free and very healthy!

In 1989, the first cord blood stem cell transplant occurred in the United States, at the University of Cincinnati. In 1991 a transplant was performed on a child with chronic myelogenous leukemia. These two transplants were highly successful, thereby “setting the stage” for cord blood transplants in situations where bone marrow transplants had traditionally been used.

In 1992, the first private storage of a baby’s UCB occurred.

In 1993, the Umbilical Cord Blood Bank at the New York Blood Center was founded by Dr. Pablo Rubenstein. This is the largest public cord blood bank in the United States; with over 1,000 cord blood transplant units used to date.

In 1995, in the Lancet Report, Wagner and his colleagues studied cord blood transplants with “related recipients”. The results showed survival and engraftment rates similar to bone marrow transplants.

In 1997, in a NEJM report, Gluckman and colleagues published results of the overall survival rates at one year, of both related and unrelated cord blood transplant recipients. Survival rates were noted to be 63% for related donors and 29% for unrelated donors.

In 1998, the first ever autologous transplant of privately banked UCB stem cells occurred, when a family in Brazil with a history of cancer in a young son decided to bank their next child’s UCB. The baby developed Neuroblastoma and underwent a successful autologous stem cell transplant (her own stem cells).

In 2000, in a retrospective comparison, Roche and colleagues demonstrate results of lower acute and chronic GVHD in cord blood stem cell transplants as compared to bone marrow transplants.

In 2001, the first study of cord blood transplants in adults was published; reporting that 90% of the transplants engrafted. On 12/10/01 – the first autologous cord blood transplant from a private bank occurred in the US. Also in December of 2001, several clinical trials were underway to study the results of multiple mis-matched cord blood units in adults.

In 2003, over 3,000 cord blood transplants have been completed worldwide since 1988, with the majority of these being done in the last 2 to 3 years.

Into 2004, research indicates that unrelated UCB stem cell use in adult transplantations is a viable option for these patients and should continue to be studied.
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19) WHICH FAMILIES CHOOSE TO STORE THEIR BABY'S UCB?
Most families that choose to store their baby’s UCB have no family history or medical condition pre-disposing them to an immediate need. These families are preserving their baby’s cord blood for simple “peace of mind”, a type of biological insurance. A growing number of families are choosing UCB cryopreservation based on the increasing body of knowledge as well as recent research suggesting multiple areas of medicine that may use stem cells. In addition, minority families and families of mixed ethnicity are storing cord blood simply because it is more difficult for them to find a stem cell match, if ever needed. Families with in vitro pregnancies, and adopted babies are also making this valuable choice. MiraCell believes that preserving your baby’s cord blood is a good idea, period. If your delivering physician does not mention the possibility of collecting your baby’s UCB, (whether for private or public use); please do not hesitate to initiate the subject yourself! As a parent, MiraCell supports your family, and your position to be your baby’s best advocate.
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20) WHEN DO I NEED TO ENROLL WITH MIRACELL TO HAVE MY BABY'S UCB SAVED?
As soon as possibleis the best time to enroll with MiraCell. We suggest a minimum of 6 weeks prior to your delivery date, but it is never too late! You will receive a cord blood collection kit from us within 10 days of your enrollment completion. Many hospitals within the Kansas City Metro area have MiraCell collection kits available for emergent collections.
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21) WHAT ARE THE CHANCES MY FAMILY WILL NEED TO USE THESE UCB STEM CELLS?
Taking into consideration the fact that the science of stem cell therapy is expanding daily, and that the cause of most cancers are unknown, it is impossible to determine the exact odds of a specific family member needing a stem cell transplant. A study by F. Leonard Johnson, published in the Journal of Pediatric Hematology/Oncology, 1997, estimated the odds of a child needing to use their own (autologous) stem cells as that of 1:2,700; and the odds that a family member would need to use those stem cells at about 1:1,400. This study did not include consideration of adult usage (over the age of 21), the use of stem cells in mini-transplants for adults, or potential uses for stem cells in the future (such as diabetes, lupus, MS, rheumatoid arthritis, etc…). More and more uses for UCB stem cells are being discovered every year. However, there is no guarantee that stem cells will provide a cure or be an appropriate treatment for every medical need.
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22) WHAT NEEDS TO BE DONE IF THE STORED UCB STEM CELLS ARE NEEDED?
Just notify MiraCell at our toll free number (1-877-355-7836) if your stored stem cell unit is ever needed. A medical release form will need to be signed. MiraCell will then obtain the name and address of the hospital where this stem cell unit will be transported for use, as well as the transplantation physician’s information. Further detail concerning the immediate shipping will then be accomplished between MiraCell, the transplant physician and the receiving hospital.
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23) IS THERE A CHARGE TO RETRIEVE THE STORED UCB STEM CELLS?
There is no set or standard fee for the sample retrieval. The only fees will be those for lab testing, which will vary depending on the requests and requirements of the transplant physician; and those for shipping of the unit to the hospital where the actual stem cell transplant will occur. These fees may be billable to your insurance company, and all preparation, testing and shipping of the stem cell unit is done according to the most current industry standards.
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24) WHO IS RESPONSIBLE FOR INFORMING THE NECESSARY PEOPLE ABOUT THE COLLECTION?
You will be responsible for informing your physician or midwife of your decision to collect and bank your baby’s UCB, and that you have chosen MiraCell as your UCB bank. MiraCell will also contact your delivering physician or midwife, as well as your delivery hospital of choice. Before your delivery, MiraCell will endeavor to ensure that all health care staff is informed and comfortable with the UCB collection procedure, as well as the MiraCell collection kit, by offering education and inservicing to any healthcare professionals interested in gaining further knowledge about the collection process.
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25) HOW DOES MIRACELL STORE MY BABY'S STEM CELLS, AND IS IT CONSIDERED A SAFE METHOD OF STORAGE?
Your baby’s stem cells will be stored at MiraCell in the advanced cryopreservation BioArchive® System, made by ThermoGenesis® Corp.. The BioArchive system has the capability of freezing, placing, and retrieving stem cell samples within liquid nitrogen WITHOUT exposing the unit to detrimental transient warming events (TWE’s). (TWE’s can happen when standard cryogenic containers are accessed for new UCB unit placements or retrievals and these TWE’s are thought to reduce cell viability!) The BioArchive system will store your baby’s stem cells at a constant -196°C, as well as archive all storage data should this historical data information become necessary for retrieval one day (required for transplantation). The BioArchive® System is capable of storing 3,626 units of stem cells in 25 ml. cryogenic bags, in a liquid nitrogen environment after undergoing a controlled rate freezing process. An additional safety feature is that of the uninterruptible power source (UPS), which allows for completion of stem cell unit placement or retrieval, in the event of a power failure. By reducing the opportunity of human error, eliminating the possibility of stem cell unit misplacement, and increasing the consistency and safety of handling, MiraCell believes that the BEST cryogenic equipment available today is the BioArchive® System, by ThermoGenesis® Corp. The BioArchive® System is the cryogenic equipment used and preferred by two of the nations leading US public cord blood banks and many foreign countries as well.
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26) HOW LONG CAN MY BABY'S UCB STEM CELLS BE STORED ?
It is believed that stem cells can be successfully stored for a very long time in a cryopreserved state. The New York State Health Department Guidelines for cord blood banking states: “There is no evidence at present that cells stored at -196°C in an undisturbed manner lose either in-vitro determined viability or biologic activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen”. Ultimate length of cryopreservation storage time, continuing to yield a viable stem cell has not been determined. This is because stem cell cryopreservation is a newer science or procedure. We know for sure stem cells can be successfully cryopreserved for at least 15 years and continue to yield a viable / useful unit for transplantation; as 15 years ago is when this science of cryopreserving stem cells began!
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27) HOW DOES MIRACELL RECEIVE MY BABY'S UCB AND WHAT HAPPENS WITH IT NEXT?
You will call MiraCell within 2 hours after your delivery, and they will be responsible for activation of a courier to your hospital of delivery. A courier will come to your hospital room, or delivery floor (depending upon the hospital’s policy) to pick up the packaged blood products for immediate transport to MiraCell’s lab. Once your baby’s valuable UCB has been received at MiraCell, your family will be promptly notified. You will then know that the blood has arrived, and that processing has been initiated!
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28) WHAT HAPPENS TO THE UCB DURING PROCESSING AT MIRACELL?
The received blood is visually inspected, then weighed for the exact volume collected. By scanning the barcodes on the blood bag and maternal specimen labels, MiraCell’s blood bank laboratory will immediately match the received cord blood and maternal blood specimen information with your enrollment information previously entered into the database. This process ensures that laboratory results, storage information and client database information are securely matched. MiraCell has implemented the processing protocol from the New York Cord Blood Bank for Reduction of Red Cells and Plasma from Placenta Blood.

The baby’s UCB undergoes the following testing: fungal and bacterial cultures (aerobic and anaerobic), cell viability, TNC (total nucleated cell count), CD34+, ABO and Rh. If parents desire, MiraCell will send a copy of the following results to the baby’s doctor: volume collected, the TNC (this is most important for a successful engraftment process), and the CD34+ cell count (tells the concentration of stem cells collected, and can also be an important indicator of successful engraftment).

The mother’s blood undergoes testing for: Hepatitis B Surface antigen and antibody (core), HIV I & II antibody and Nucleic Acid Testing, Hepatitis C by antibody and Nucleic Acid Testing, CMV and HTLV I & II by antibody, Syphilis serology, blood group and type (ABO & Rh) with screen for atypical antibodies.

The cord blood cells are processed and separated, sterilely transferred to a specially designed 25 ml blood bag, and then cryopreserved by adding DMSO (this protects the cells during cryopreservation). The 25 ml blood bag of protected stem cells is then sealed in an additional protective cryogenic plastic over wrap and placed in the BioArchive® System for long term storage.
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29) IS MIRACELL'S LABORATORY REGISTERED, AND DO THEY HAVE CERTIFICATION?
Absolutely! MiraCell is registered with the Food and Drug Administration (FDA) and operates within the confines of a Laboratory certified by Clinical Laboratory Improvement Amendments (CLIA), and utilizes state of the art equipment for processing and storing umbilical cord blood (UCB) stem cells. MiraCell has been trained according to, and has implemented the processing protocol from the New York Cord Blood Center for Reduction of Red Cells and Plasma from Placental Blood*. MiraCell is registered with the American Association of Blood Banks (AABB) as an institutional member and will commence with the AABB laboratory accreditation process later in 2004. Although AABB accreditation is strictly voluntary, MiraCell acknowledges the important role the AABB fulfills by setting standards for the blood banking industry.
 * Clinical training provided by ThermoGenesis Corp.
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30) CAN THALASSEMIA BE TREATED WITH UMBILICAL CORD BLOOD (UCB) STEM CELLS?
Thalassemia is a rare and complex disease mainly affecting those of Greek or Italian decent. Thalassemia is considered a nonmalignant disease, and an inherited red cell (erythrocyte) abnormality that CAN be, and has been, successfully treated with Umbilical Cord Blood (UCB) Stem Cells. Thalassemia is a genetic form of anemia in which there is an abnormality of the globin portion of the hemoglobin molecule. Those individuals affected by Thalassemia cannot synthesize hemoglobin properly, and they produce small, pale, short-lived red blood cells. Thalassemia is not just one disease, but rather a complexity of genetic or inherited disorders all of which involve the underproduction of hemoglobin (the molecule in red blood cells that carries oxygen).
There are three types of Beta Thalassemia:

  • Beta Thalassemia Major - first described in 1925 by the pediatrician Thomas Benton Cooley, Beta Thalassemia Major is also often called "Cooley's Anemia".1 This is the most severe form of the Beta Thalassemia's. Children with Beta Thalassemia Major inherit one gene for the disorder from each of their parents. Infants with Beta Thalassemia Major seem entirely normal at birth, with the symptoms of the disorder surfacing within a few months. Once symptoms surface, the Thalassemia becomes progressively more severe, leading to: failure to thrive (grow), easy fatigue ability, pallor, bouts of fever (secondary to infections) and diarrhea. The treatment for Beta Thalassemia Major has been based solely on repeated blood transfusions and chelation therapy (to reduce iron overload); and has been helpful, but not curative. Umbilical Cord Blood (UCB) stem cells have changed this Thallasemia treatment option to a cure.
  • Thallasemia Intermedia - a variation of Beta Thalassemia Major, characterized by an intermediate degree of severity. These patients may have severe anemia, but generally don't require regular blood transfusions.
  • Thalassemia Minor - is sometimes called Thalassemia trait, as it is the carrier trait for Beta Thalassemia. Those who have this variation of Thalassemia have only one Thalassemia gene and are essentially normal.
More and more families that have either an affected family member that could directly benefit from an Umbilical Cord Blood (UCB) stem cell transplant, or a family member that simply carries the Thallasemia trait and could possibly benefit in the future by opting to collect and store their baby's Umbilical Cord Blood (UCB) stem cells. "It simply gives the family a chance to store the cord blood for potential future use. Cord Blood Center staff believe that this is an important consideration, especially since cord blood units may be used in the absence of a perfect HLA match."2
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