Asma Sultan Alolama, MD

Private Cord Blood Banking Should it be allowed?

Asma Sultan Alolama, M.D

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”

What is UCB? It’s the blood remaining in the Umbilical

cord & placenta after cutting the UC; considered a waste

At Birth

Before the delivery of the placenta

After the delivery of the placenta

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

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

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

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

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 HSCTOr2- The Parent of the expected child has a disease that can be successfully treated with HSCT & there are shred HLA-antigens between the parentsFor private use, in case a need arise in the future

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

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

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

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

Public donation of CB is recommended by:

ASBMT American College of Obstetric &

Gynecologists (ACOG) American Academy of Pediatrics (AAP)

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

Store it for private use in the future in case a need arises is NOT recommended by:

ASBMT ACOG AAP

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”

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.

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.

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

Work on accreditation from the start Establish registry Most importantly establish your

Transplant unit before building your CB bank.