Asma Sultan Alolama, MD

1. Private Cord Blood Banking Should it be allowed? Asma Sultan Alolama, M.D Asma Sultan Alolama, MD

2. History: • In 1974, Kundtzon found HC in CB • In 1982, Nakahata found that CB contain more HC than BM • In 1983, Toles proved that Hematopoietic progenitor cells were available in CB • In 1988, the First CB Stem Cell transplantation was done for a child with Fanconi’s Anemia • In 1992, Publo Rubinstein established First Public Cord Blood Bank, NY “National Cord Blood Program”

3. What is UCB? • It’s the blood remaining in the Umbilical cord & placenta after cutting the UC; considered a waste

4. At Birth After the delivery of the placenta Before the delivery of the placenta

5. Both Methods are comparable in terms of : -total blood volume -CD 34 + count -Total Nucleated Cell count • The major issues in obtaining high quality units for transplantation are: -Maximizing the volume of blood collected -Avoiding microbial contamination -Avoiding undue delays that could result in clotting of the specimen

6. Place 25 ml CB in quarantine overwrap & inser in canister Remove most of RBC/plasma & isolate SC into 20 ml autoxpress device & add 5 ml DMSO Insert unit into controlled rate freezing & initiated automatic controlled freezing Archive the unit into bio archive system

7. Unrelated UCB is a useful alternative HSCT for patients without suitably matched & readily available related or unrelated stem cell donors. • Currently > 450,000 CB grafts are available in > 50 CB banks. • It has been estimated that > 20,000 UCB transplantation have been performed worldwide. • >2,000 CB transplants are done worldwide/yr

8. CB Advantage: Disadvantage: • Rapid availability • Absence of risk for the donor • Decreased incidence of aGVHD • Less stringent HLA matching • Relatively low cell dose, particularly for adult & large size children • Unavailability of donor for later DLI if needed

9. Types of CB banking: • Public • For family use: 1-when a sibling of the expected child has a disease than can be successfully treated with HSCT Or 2- The Parent of the expected child has a disease that can be successfully treated with HSCT & there are shred HLA-antigens between the parents • For private use, in case a need arise in the future

10. A stored CB in a public bank is at least 100 times more likely to be released for transplantation than a unit that is privately stored. • The probability of using one’s own CB is very small, probably as low as 0.04% (1:2500) to 0.0005% (1:200,000) in the first 20 yrs of life • Yet the number of privately stored units exceeds those in public banks by > 3-folds & continues to grow. • Worldwide, there are approx 134 private banks

11. Recommendation for HLA & Cell dose: • CB with 6/6 or 5/6 HLA match • Malignant disorders: • Nucleated cell dose: -at freezing, min 2.5-3.0 X 10 7/kg - at thawing, 2.0-2.5 X 10 7/kg • CD34+ cell dose: at freezing or at thawing aprox 1.2-1.7 X 10 5/kg • Non-Malignant disorders: Same

12. CB unit with 4/6 HLA mismatch: • Malignant disorders: • Nucleated cell dose; -at freezing, min cell dose 3.5 X 10 7/kg - at thawing, min 3.0 X 10 7/kg • CD34 + cell dose; at freezing or after thawing, approx >1.7 X10 5/kg • Non-Malignant disorders: • Nucleated cell dose; at freezing, min cell dose of 4-5 X10 7/kg, at thawing, min 3.5 X10 7/kg • CD 34+ cell dose; at freezing or thawing; > 1.7 X10 5/kg

13. Concerns regarding storage of CB for future Autologous use include: • Low probability of clinical need 1:2500- 1: 200,000 (0.04%-0.0005%) • Quality & Viability: The standards for public CB banking & private CB banking may differ in terms of maternal eligibility & nucleated cell count requirement & these factors may influence the oveall quality of the stored CB. • Latent Disease: the abnormal or diseased cells that cause the disease later in life may be present in the patient’s preserved CB • Lack of GVL effect

14. Public donation of CB is recommended by: • ASBMT • American College of Obstetric & Gynecologists (ACOG) • American Academy of Pediatrics (AAP)

15. Store it for Family use because the baby’s sibling has a disease that can be successfully treated by CB transplant or a parent (with shared Ag) has a disease that can be treated by CB transplant is Recommended by: • ASBMT • ACOG • AAP

16. Store it for private use in the future in case a need arises is NOT recommended by: • ASBMT • ACOG • AAP

17. Private CB banking is banned in • Italy • France • KSA • The European Union position states “the legitimacy of commercial CB banks for autologous use should be questioned as they sell a service that has presently no real use regarding therapeutic option”

18. Why then the private CB banks are on the rise? • The reason for widespread private banking include: • Parental interest in giving their children “biological insurance” in case a disease develops in future yrs & can be treated by ASCT. • Aggressive marketing by banks offering private collection & storage of CB. • The economics of CB banking have enabled a rapid expansion of private banking.

19. A public bank recovers costs only when the CB unit is shipped for transplantation, whereas a private bank receives immediate income when the CBU is collected & ongoing annual income for maintenance of the stored unit.

20. Take home message: • Encourage parents to donate their cord blood for public use, • Recommend CB for family use only if a sibling or parent have a disease that can be treated with HSCT • Discourage parents from private banking: this requires public education to counteract the marketing of the private banks

21. Work on accreditation from the start • Establish registry • Most importantly establish your Transplant unit before building your CB bank.