Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program (2005) / Chapter Skim
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4 Umbilical Cord Blood Banks and Banking
4 Umbilical Cord Blood Banks and Banking
Pages 75-105
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From page 75... ...
Yet the rules are not standardized and a more consistently applied set of regulations would benefit both the cord blood banks and end users. Finally, existing cord blood collections lack sufficient ethnic and racial diversity to ensure adequate probability of finding HLA-matched units for some ethnic and racial groups, which is a particularly important barrier to the fundamental goal of unimpeded access to needed treatment.
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From page 76... ...
For the purposes of this report, the committee has classified cord blood banks into three main categories. Public banks store unrelated cord blood units that are philanthropically donated for transplantation or research purposes.
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From page 77... ...
77 consent Center Recipient Thawing Search initiated Transplantation Transplant of typing data -up Collection follow Confirmatory Request received Shipping added transplantation. database Unit to and banking, results HLA Typing Freezing Infectious disease test bank collection, Bank the registers at blood bank of Mother with arrives testing cord Extraction, labeling, counting Unit Review maternal history of Infectious disease process the count in Consent weight TNC and step order components information Center Collection Major Indicates alternative Indicates 4-1 Collection FIGURE
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From page 78... ...
a family members) Option 2: philanthropic Unit will be saved for No fee donation potential use by the general public Option 3: research Procurement directed to an No fee to family but some donation institution researching the research organizations are properties of umbilical cord charged blood units Option 4: directed Collection to serve a Usually offered by the donationb patient in need, usually a transplant centers no cost sibling or other family to the family; also offered member by some public and private banks; transplant centers may be charged to procure the unit a If there is a history of a genetic disease or condition or a malignancy within the family, it is possible that insurance will cover these costs.
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From page 79... ...
Further, as the obstetricians are not reimbursed by the public banking system the way they are with many private banks, it is also important that they fully "buy in" to the advantages of the public system. STATUS OF CURRENT BANKS: RESULTS OF A SURVEY The committee identified 40 cord blood banks in the United States (see Appendix C)
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From page 80... ...
Louis Cord Blood Bank, >40,000 units; the National Cord Blood Program of the New York Blood Center, 29,525 units; the American Red Cross Cord Blood Program, 18,680 units; Lifebank USA, 17,228 units; the Carolinas Cord Blood Bank, 17,000 units; Cryobanks International, Inc., 15,429 units; and StemCyte International Cord Blood Bank and Cord Blood Family Trust, 13,566 units. Collection Processes All but three of the cord blood banks indicated that obstetricians are among those who perform the cord blood collection.
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From page 81... ...
with the exceptions of ITxM Cord Blood services, the Sibling Donor Cord Blood Program, and StemCyte International Cord Blood Banks and Cord Blood Family Trust. The most popular anticoagulant and cryoprotectant agents were citratephosphate-dextrose (CPD)
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From page 82... ...
Collection of Cord Blood Units Cord blood can be collected from the placenta at two different times. It can be collected after delivery of the baby but before the placenta has been delivered, or it can be collected in a separate room after the placenta has been delivered.
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From page 83... ...
In addition, it is very important that the accrediting organization contact those currently in the practice of both collecting and storing cord blood in order to ensure that the standards are both reasonable and effective. Recommendation 4.2: Uniform standards for the collection of cord blood units without alteration of safe obstetrical practice should be established by the Cord Blood Accrediting Organization suggested in Recommendation 4.1 and should be required of all banks participating in the National Cord Blood Stem Cell Bank Program.
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From page 84... ...
Storage Cryopreservation5 is the standard practice for long-term storage of cord blood units for transplantation. Engraftment of stem cells from cord blood has been shown to be successful from cryopreserved units that were subsequently thawed by careful, specific procedures (Galmes et al., 1995, 1999; Rubinstein et al., 1995; Rubinstein, 2001, 2004; Timeus et al., 2003)
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From page 85... ...
(2002) have attempted to further simplify the process of short-term storage of cord blood units by using supercooling instead of freezing the units in liquid nitrogen.
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From page 86... ...
For this reason, standards should be consistent, scientifically validated, and designed with the input of current cord blood bankers and cord blood experts. Recommendation 4.3: Uniform quality assurance standards and crite ria should be established by the proposed Cord Blood Accrediting Organization for the collection, processing, and storage of cord blood, and adherence to these standards should be required of all banks par ticipating in the National Cord Blood Stem Cell Bank Program.
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From page 87... ...
In four of the five areas studied, cord blood banks recruited a lower percentage of minorities (in comparison with the census data for the corresponding collection hospitals)
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From page 88... ...
age. 7 No match of ×10 218 cord years 3.0 candidates 20 of Urgent than dose 1,367 ansplanttr match 6/6 5/6 4/6 cell more Cord 94 447 608 patients minimum a unrelated ansplanttr for cord and orf No cord blood units or match 42 match w w cord blood Candidates marro marro cord match No umbilical 4/6 5,467 donor 52 6/6 5/6 Cord 0 0 10 50,000 versus with urgent candidates E
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From page 89... ...
ansplanttr of 7 ×10 years Urgent 3.0 20 match of 6/6 5/6 4/6 683 candidates than dose Cord 155 365 149 less cell unrelated ansplanttr patients cord for minimum orf a No cord match 34 match or blood and w w cord units marro Candidates marro No match blood 5/6 4/6 2,733 6/6 umbilical donor 700 cord Cord 7 331 327 versus 50,000 urgent candidates E marrow with Non cord bone 2,050 ansplanttr No 4 match of scenario Appendix 8/8 match the See w No in match selection w 594 high-resolution marro match for (2005)
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From page 90... ...
Cord blood banks have been able to recruit a diverse donor population, but it is not fully consistent with the census data on the racial and ethnic
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From page 91... ...
Organizations such as NYBC have attempted to make this process easier by implementing programs that facilitate the use of cord blood and increase the referrals for transplantation. Cord blood banks rely on the use of these units, as reimbursement comes with the clinical transplantation of a cord blood unit and not with the donation.
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From page 92... ...
The FDA proposal contains several exceptions involving minimally manipulated cells, including cells that are harvested for autologous or reproductive use but that are not processed and stored for commercial use, such as for the directed donation of cord blood units or ova for infertility (FDA, 2004b)
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From page 93... ...
the role of the CD34+ cell count in the selection of cord blood units, and 3. other measures of quality that should be considered (BRMAC, 2003)
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From page 94... ...
Recommendation 4.4: The Food and Drug Administration should move promptly to establish a system of licensure of cord blood units intended for clinical transplantation. As an interim measure until a licensure process is established, all banks participating in the National Cord Blood Stem Cell Bank Program should operate under an investi gational new drug application.
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From page 95... ...
Under these laws, a hospital "shall allow a pregnant patient to arrange for the donation of the blood extracted from the umbilical cord of the patient's newborn child to a certified7 public cord blood bank" (State of Illinois, 2004; State of Maryland, 2004a, 2004b)
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From page 96... ...
ACCREDITATION American Association of Blood Banks (AABB) AABB first included standards relating to HPCs and bone marrow in 1991 as part of the 14th edition of Standards for Blood Banks and Transfusion Services (Section Q)
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From page 97... ...
FACT inspection teams always include a team leader, a physician trained in stem cell transplantation, and professional experts in the areas of stem cell collection and laboratory practices. The inspection team assesses the compliance of a facility with the standards and reports back to an
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From page 98... ...
The FACT/NetCord collaboration was intended to ensure consistently high- quality cord blood units for transplantation not only in the United States but also internationally. FACT/NetCord recognizes that global standardization of cord blood banking will facilitate the availability of quality cord blood units for a greater number of U.S.
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From page 99... ...
They apply to all activities related to donor screening, collection, processing, release, and transplantation of bone marrow, peripheral blood, and cord blood progenitor cells facilitated through the NMDP network of banks and transplant centers. Recommended Direction In contrast to adult marrow and peripheral blood donors, who can be examined immediately prior to harvest, the umbilical cord blood donor is not available for additional testing.
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From page 100... ...
Cord Blood Bank Cord blood units are transferred from the collection site to the cord blood bank where they are processed, tested, and cryopreserved for longterm storage until they are retrieved for transplantation. Each step in this process must be performed properly to ensure a satisfactory outcome for 8Though if the patient does manage to survive in the short-term without engraftment, subsequent transplants or autologous recovery may ensure long-term survival.
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From page 101... ...
The IND annual report should be shared with the accrediting agency and oversight board. Transplant Facility Transplant centers that receive cord blood units from the proposed national program should be accredited and should adhere to standards.
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From page 102... ...
Collection centers, banks, and transplant centers should maintain their accreditation and should report the required data to continue to participate in the National Cord Blood Stem Cell Bank Program. The accrediting agency should have a policy in place to detect facilities that become noncompliant in the interim between inspections.
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From page 103... ...
Although the committee did not want to explicitly address the differences between the two systems of banking or the merits of one over the other, there was no question that individuals storing units with private banks should be assured of the quality of the banks. For this reason, all quality standards adopted by the proposed National Cord Blood Stem Cell Bank Program should apply to both public and private cord blood banks.
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From page 104... ...
Presentation by WJ Hartzler at the Workshop of the Institute of Medicine Committee on Establishing a National Cord Blood Stem Cell Bank Program, June 2, Washington, DC. Florida State Legislature.
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From page 105... ...
2004. Cord blood units collected at a remote site: A collaborative endeavor to collect umbilical cord blood through the Hawaii Cord Blood Bank and store the units at the Puget Sound Blood Center.
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