Page 1708 - Hematology_ Basic Principles and Practice ( PDFDrive )

1518 Part IX Cell-Based Therapies

Choice of Hematopoietic Stem Cell Product for Transplantation Evaluation of the Allogeneic or Syngeneic Marrow or Peripheral Blood
Stem Cell Donor
Virtually all patients undergoing autologous hematopoietic stem cell
(HSC) transplantation will have peripheral blood stem cells (PBSCs) Hematopoietic stem cell (HSC) transplantation involves the infusion
as the source of HSC, based on the following advantages: ease of of a “blood product”, and allogeneic and syngeneic donors must
collection, greater quantities of HSCs (resulting in faster hematologic be evaluated for risks for disease transmission as per the current
recovery and shorter and less costly hospital stays), and potentially criteria for blood or tissue donation (“donor eligibility”). Exemptions
lower risks for tumor cell contamination of the graft. from criteria that specifically address the risk for disease transmission
The allogeneic donor has a wider range of options, including marrow, are permissible, if the risks of excluding an otherwise appropriate
PBSCs, or umbilical cord blood (UCB) products from human leuko- donor outweigh the risks for disease transmission to the transplant
cyte antigen-compatible or partially compatible related or unrelated recipient, who may not have an alternate donor. Informed consent must
donors. The transplant recipient may request a source of cells, but be obtained for the evaluation and collection procedures. Informed
the donor has the right to decide about the method of donation. PBSC consent also must be specifically obtained for the release of protected
products have the greatest quantity of HSCs and will result in faster donor health information to the transplant recipient, allowing proper
hematologic recovery compared with marrow or UCB transplants. In informed consent for the transplant to be obtained. Minors and donors
some reports, PBSC transplantation resulted in a survival advantage. not competent to provide consent must be represented by a third party
However, PBSC transplantation is also associated with a higher risk not involved in the care of the recipient. Ideally, similar courtesy will be
for difficult-to-control chronic graft-versus-host disease (GVHD) and provided to the adult competent donor.
may not be appropriate for use in patients who would not benefit Donors must also be evaluated for health issues that would increase
from a robust graft-versus-leukemia effect, such as those treated for the risks resulting from the collection procedures (“donor suitability”).
nonmalignant disease. UCB has the advantage of being immediately For marrow donors, this includes the risks of anesthesia and harvesting
available, reducing the time to transplantation. Targeted collection in the prone position; for PBSC donors, evaluation should include the
of UCB products from ethnic populations not well represented in risks of mobilization medications and apheresis, including the need for
the various donor registries will facilitate treatment of ethnic minority venous catheter placement.
patients. The relative immature immunity of the cord blood donors The donor collection facility’s standard operating procedures for
allows the use of human leukocyte antigen-mismatched products evaluation of HSC donors must meet the Foundation for the Accredi-
without an undue increase in GVHD risk. Infusion of two cord blood tation of Cellular Therapy/Joint Accreditation Committee or AABB
units may achieve a greater graft-versus-tumor effect (this concept standards and United States Food and Drug Administration (or other
has not been proven), even though one unit will be rejected. The regulatory agency) regulations, and include policies and procedures
much smaller quantity of HSCs in the cord blood product results in for the following:
slower hematologic recovery, and the adult patient, in particular, may • Education of donor, including education regarding procedures,
be at greater risk for posttransplant infection because of the relative risks and alternatives, and possible request for future donations;
immature immune system of the donor. • Medical history, including special attention to history of
autoimmune disorders, arthritis, cardiac and vascular disease,
and history of cancer;
• History of high-risk behaviors, such as recent tattoos, body
(“donor suitability”) and the risks for transmission of disease from the piercing, sexual practices, and travel;
donor to the recipient (“donor eligibility”). The same general health • Physical examination, including vein assessment (PBSC donors)
criteria apply to both bone marrow and PBSC donors. Patients and oral examination (marrow donors undergoing inhalational
undergoing autologous HSC collection and transplantation are not anesthesia);
at risk for transmitting disease to themselves, and determination of • Laboratory studies, including verification human leukocyte
antigen typing, ABO typing, complete blood count, chemistry
donor eligibility is not medically required or economically justifiable, panel, infectious disease panel, urinalysis, ECG, CXR;
but these patients must be evaluated for their suitability for the col- • Consent for the collection procedures and the release of
lection procedures. All allogeneic and syngeneic HSC donors must be protected health information to the stem cell recipient;
evaluated for donor eligibility, as well as suitability, using the same • Documentation of both donor eligibility and suitability before
criteria currently applied to blood or other tissue donors, including a initiation of the transplant conditioning regimen.
targeted history regarding behaviors exposing the donor to infection,
recent or concurrent illnesses, and medication use. 22–26 This evaluation
of the allogeneic donor suitability and eligibility must be clearly docu-
mented in the donor medical record, with appropriate additional underlying health problems. Pediatric donors present different chal-
documentation of donor eligibility placed in the intended recipient’s lenges, based on the smaller size and varying ages (and ability to
medical record before initiation of the transplant conditioning cooperate) of the donors (see box on Evaluation of the Allogeneic or
regimen. Older donors have a greater probability of comorbid medical Syngeneic Marrow or Peripheral Blood Stem Cell Donor).
conditions, which will increase the risks of the collection procedures, Use of a donor who does not meet eligibility criteria and who
and the risks to the allogeneic donor with underlying health problems poses a risk for transmission of disease requires appropriate informed
must be fully considered before subjecting the donor to HSC collec- consent both from the donor (for disclosure of this confidential
tion. Published standards describe evaluation of the donor for the risk health information to the recipient and for counseling of the recipi-
of the donation process, as well as the risk for transmission of disease ent) and from the recipient (for use of the stem cell product). The
to the recipient. 22–24,26 Evaluation by appropriate consultants may potential conflict of interest between protecting donor confidentiality
be required before autologous or allogeneic donor approval is final- and patient needs must be recognized by the personnel caring for
ized. Procedures involving donors with acute infectious illnesses each person, and preferably, the donor and patient should be repre-
should be delayed, if at all possible, because of the risk for disease sented by different physicians. 29
transmission. Genetic disorders, such as hemoglobinopathies, will be
transmitted to the recipient as a direct consequence of stem cell
engraftment. Cancer can be transmitted, as illustrated by the transmis- Determination of Suitability for Bone Marrow Donation
sion of donor leukemia not detected during initial evaluation of the
27
donor, and donors previously treated for cancer should be evaluated Anesthesia and blood loss present the greatest risks for serious com-
for the probability of recurrent disease that could be transferred to the plications to the bone marrow donor. Most marrow harvesting is
28
immunocompromised recipient. Collection of PBSCs is generally performed under general anesthesia, which requires intubation for
an outpatient procedure conducted in the clinic setting. In contrast, control of the airway for a surgical procedure being performed on a
marrow harvesting has the luxury of the intensive support capability prone patient. Regional (spinal or epidural) anesthesia may not be
of the operating room. PBSC collection, therefore, should never be effectively established, so patients and donors who express a prefer-
viewed as a safer alternative to marrow harvesting for the donor with ence for this form of anesthesia must be counseled about the potential