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

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 Before the delivery of the placenta After 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. Remove most of RBC/plasma & isolate SC into 20 ml autoxpress device & add 5 ml DMSO Place 25 ml CB in quarantine overwrap & inser in canister 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: 1. 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.  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.  The reason for widespread private banking include: a) Parental interest in giving their children “biological insurance” in case a disease develops in future yrs & can be treated by ASCT. b) Aggressive marketing by banks offering private collection & storage of CB. c) 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.

22. Thank you