Cord Blood : Past, Present and Future

1. Cord Blood : Past, Present and Future Presented By: Mary C. Wiegel Program Manager / Educator ITxM Clinical Services Dan Berger Cord Blood Program

2. About Cord Blood • 2005 – C.W. Bill Young Transplantation Program, the Stem Cell Therapeutic and Research Act of 2005 created the National Cord Blood Inventory (NCBI) with the goal of increasing the national supply of publicly donated cord blood units

3. States with Cord Blood Legislation

4. Bipartisan Legislation Promoting Life-Saving Medical Advances Clears Senate The Stem Cell Therapeutic and Research Reauthorization Act of 2010 (S. 3751), unanimously approved by the Senate today, reauthorizes the original 2005 act and extends the C.W. Bill Young Cell Transplantation and National Cord Blood Inventory (NCBI) programs through Fiscal Year 2015.

5. ACOG Committee Opinion# 399. February 2008 • Recommendations (Information to Patient) • balanced and accurate information on advantages and disadvantages of public vs. private • Remote chance of autologous unit being used of 1 in 2700 individuals • Disclosure that demographic data will be maintained, maternal infectious disease and genetic testing, ultimate outcome of poor quality units • Provider not obligated to obtain consent for private banking • Collection should not alter routine delivery practices • Disclose any financial and conflict of interest for for-profit UCBB

6. Cord Blood Donation comes to Western Pennsylvania • October 8, 2007, the creation of the Dan Berger Cord Blood Program was announced at Magee-Womens Hospital of UPMC. • Named for the late Dan Berger, a prominent Pittsburgh attorney and humanitarian who underwent a successful unrelated stem cell transplant to overcome cancer, but then tragically died of a heart attack in 2006

7. Cord Blood Program • To educate all parents-to-be about their cord blood options: Private Banking Donate to a Public Bank Research Throw away as medical waste • Hope that all parents-to-be will make an educated decision to save / donate • Expand the program so that all expectant parents know about their options and can make a difference

8. Principles of the Cord Blood Program • To collect from an ethnically diverse donor pool • To bank large volume units to maximize clinical usefulness • To have units of the highest quality • To support research in the area of cord blood banking and transplantation

9. Why Start a Cord Blood Program? • Umbilical cords and placental tissue are routinely discarded as medical waste • Stem cells from cords have been used to treat more than 70 diseases • Stem Cell and Bone Marrow transplants account for more than 10,000 transplants worldwide (NMDP) • Easier to match stem cells from cord blood than bone marrow: Three Sources for stem cells: Bone Marrow Peripheral Blood Umbilical Cord Blood / Placental Blood

10. Stem Cells • Embryonic Stem Cells • Derived from four to five day old embryos • Adult Stem Cells • Undifferentiated cells found among differentiated cells in a tissue or organ

11. Embryonic Stem Cells Human Embryonic Stem Cells • Obtained from donated embryos that have developed from eggs fertilized in vitro (in the lab) • Potentially unlimited capacity to replenish themselves and are pluripotent, meaning that they can differentiate into any cell type found in the adult body. • Embryonic stem cell therapies have been proposed for regenerative medicine and tissue replacement after injury or disease.

12. Cord Blood Stem Cells • Cord blood contains embryonic-like stem cells. • Cord blood stem cell is not quite as primitive as the controversial embryonic stem cells, which can give rise to any tissue type of the body. • CB cells are more versatile than adult stem cells such as those found in bone marrow.

13. Adult Stem Cells • An adult stem cell is an undifferentiated cell found in a tissue or organ. • Produces more stem cells and can also give rise to specialized cell types of the tissue or organ they are located in. • The main job of an adult stem cell is to maintain and repair the tissue in which it is found. • When compared to embryonic and cord blood stem cell, adult stem cells are believed to be more limited in the type of cells that they can generate.

14. Cord Blood Options • Private Banking -- “Family Banking” • Public Banking – “Donation” • Research • Throw away

15. Private Banking (Fee-Based Companies) • Over 29 Private banks in the U.S. • Pay initial collection and processing fee: Ranges between $1500 to $2500 • Annual storage fee: ranges from $100 to $150 • Each company has different payment plans and discounts. Contact to discuss costs • Cord Blood stem cells survive after freezing for up to 15 years • ACOG Committee Opinion; “Parents should not be sold this service without a realistic assessment of their likelihood of return on investment”

16. Public Donation (NO COST) • Donate to a public bank, can benefit anyone who needs a match • Greater Access by the general public • There are approximately 40 diseases that are utilizing cord blood stem cells in their treatments • In regards to the NMDP, National Marrow Donor Program, a baby’s donated cord blood can assist anyone in the nation / world in need of a stem cell transplant. • Cord Blood stem cells survive after freezing for up to 15 years

17. Research (No Cost) • There are multiple research projects looking for treatments to certain diseases. • Some Hospitals have a research facility associated with them to offer this option to their patients • Public donation banks offer units to be utilized in research projects

18. Throw away as medical waste • One option everyone is trying to eliminate • Don’t care which option you choose, just choose one • Don’t let something so vital get thrown away as garbage when it could help someone

19. What gets thrown away in the bucket

20. Cord blood Collection and Processes • For private banking, anyone is eligible to store their own baby’s cord blood. • For donation to a public bank: Must be 18 years of age or older. Delivering a single birth. Can not donate with multiple births. This is a regulation from the NMDP (National Marrow Donor Program). In general, Good Health. • No change in obstetrical delivery and processes • Only in uncomplicated delivery ; no risk to mother or infant

21. Cord Blood Collection • Once you have made your decision, whether private or public, you must obtain your kit (private) or forms / paperwork (donation) 4 weeks before your due date. • You will keep your kit at room temperature and pack your kit (private) or forms / paperwork (donation) with your clothes to go to the hospital / facility. • If you have decided to donate your baby’s cord blood to the public bank, you will fill out the paperwork that will be sent to you before you are admitted to the hospital. • If you have decided to privately bank, you will make arrangements for the cord blood to be picked up from the company at the hospital. Usually, a courier is notified. • Once admitted, let the nurses know in Labor & Delivery (L&D), that you are donating or banking your baby’s cord blood. • 3 maternal samples are draw prior to deliver for infectious testing.

22. Cord Blood Collection (pg. 2) • The delivery stays the same. The cord blood is collected immediately after baby’s birth. The baby is delivered and after the umbilical cord is clamped / cut and the baby taken way for weighing and such, the cord blood is collected at this time. It is collected outside your body, so you will feel nothing • The moment after delivery is the only opportunity to harvest a newborn’s stem cells. • Since blood is taken from the cord only after it has been clamped / cut, there is no risk to the baby or mother. • Can be collected regardless if a woman delivers naturally or by Cesarean section.

24. 1st Cord Blood Transplant : October 6, 1988

26. More experience • Higher cell dose • Low risk of genetic disease transmission • Immune reconstitution • Donor recall is possible • Readily available • Less GVHD • Fewer HLA restrictions • Low viral transmission • No donor risk

27. Cord Blood Transplantation

28. Cord Blood Transfusion

29. Advantages of Cord Blood • Biologically, a greater degree of human leukocyte antigen mismatch between the donor and recipient is tolerated by patients, allowing more patients, including those from diverse racial and ethnic background, to receive a cord blood transplant • Relevant to African Americans • The incidence of acute and chronic graft versus host disease is decreased with UCBU • Cord blood is stored and readily available for those needing transplantation.

30. Advantages of Cord blood (pg. 2) • Hematopoietic progenitor (stem) cells from cord blood have advantages over bone marrow • Unlimited supply • Ethnic diversity easier to achieve • Painless collection • Higher proliferative capacity • Lower rate of acute graft vs. host disease (a greater HLA mismatch is better tolerated) • No donor attrition as with bone marrow

31. Indications for transplantation • Malignant Hematological Diseases • Acute leukemia: Lymphoblastic or myelogenous • Hodgkin’s lymphoma and non-Hodgkin’s lymphoma • Chronic myelogenous leukemia • Nonmalignant / Hereditary Hematological • Sickle cell anemia and thalassemia • Fanconi’ Anemia • Chronic granulomatous disease • Severe congenital neutropenia

32. Emerging Treatments of Cord blood

33. Statistics and data • For those who need a Stem cell transplant: 30% will have a sibling (family) match 70% will need an unrelated donor • By Privately storing, your child has a 1 : 2700 chance of even utilizing their own cord blood. ACOGstates that number can be larger. • These stem cells are from the umbilical cord blood and are NOT embryonic stem cells (that are controversial). • In the Catholic News Service, Pope Francis I endorses stem cell research and therapy utilizing stem cells harvested from adults and umbilical cord blood.

34. Total Growth of the Be The Match Registry® 2009 Adult Donors Cord Blood Units

35. Growth of Cord Blood Units accessible through Be The Match Registry® 2009

36. Diversity of Cord Blood Units on the Be The Match Registry® 2009

37. NMDP Transplants by Cell SourcePediatric Recipients (Age Younger Than 18 Years)

38. NMDP Transplants by Cell SourceAdult Recipients (Age 18 Years and Older)

39. NMDP Transplants for Minority Patients by Cell Source

40. Role of Cord Blood in NMDP Transplants

41. Role of Cord Blood in NMDP Transplants by Patient Race

45. NMDP Transplants Distribution of Cell Source

46. Thank you for attending the Cord Blood Program • Any questions, please contact: Mary C. Wiegel Program Manager / Educator – Western PA ITxM Clinical Services Dan Berger Cord Blood Program 412-209-7479 mwiegel@itxm.org Thank you to the following individuals for their assistance regarding the slides: NMDP (National Marrow Donor Program) Dr. Rakesh K. Goyal (Children’s Hospital of UPMC – Pgh) Dr. Haywood L. Brown (Duke University)