Ninth Circuit Approves Compensation for Bone Marrow Stem Cell Donation

Yesterday, the Ninth Circuit correctly approved compensation for donors of hematopoietic stem cells if taken from peripheral blood, instead of directly from the marrow in our bones.

Hematopoietic stem cells can differentiate into all types of blood cells, including: red blood cells, platelets, and white blood cells (T-cells, B-cells, macrophages, etc.). These stem cells are used to treat patients with cancers such as leukemia, lymphoma, and myeloma; where the patient’s own bone marrow is malignant and one, often last-ditch, treatment is for it be destroyed and then replaced by a donor’s healthy cells.

Finding a suitable donor is complicated by the fact that the donor must be HLA-matched (human leukocyte antigen). Unlike blood donations, in which there are only a handful of blood types (A, B, O, AB; and +/- for each) and one universal donor type (O-), HLA is highly polymorphic and an individual HLA locus can exhibit hundreds, or over a thousand, different alleles. This makes it particularly difficult for any mixed-race groups (including African Americans) to find a suitable match. Without a very high degree of matching, the bone marrow transplant would result not merely in rejection, but serious graft-versus-host disease and potentially kill the recipient. The NYTimes reports that around 3,000 people die each year because they cannot find a proper donor.

Previously, the National Organ Transplant Act of 1984 prohibited buying or selling of any “human organ… or subpart thereof” including bone marrow, kidney, liver, cornea, skin, etc. At the time, the method for collecting bone marrow (“aspiration”) was painful and risky–a long needle punctured the donor’s hip and extracted bone marrow tissue directly from the central cavity of the hip bone. Now, the primary means of collecting hematopoietic stem cells is from your circulating peripheral blood, through a process called “apheresis”. Several days before donation, the donor is injected with a stimulating factor (GCSF) to encourage additional migration of stem cells into the blood. A needle is inserted into a vein, the blood goes into a machine which filters out the desired stem cells, and the rest is replaced back into your body. Not only is the process very low-risk, the body will completely replace the circulating stem cells within 3-6 weeks, and in the meantime the donor still has the vast majority of blood cell production occurring in her bones. Critically, apheresis is also used in blood banks for plasma and platelet donation, which can be compensated under NOTA (along with donation of whole blood, which logically contains some hematopoietic stem cells; or packed red blood cells). Unlike aspiration, apheresis involves little pain, does not require anesthesia, and does not result in a hospital stay for the donor, yet results in better outcomes for the recipients.

From a legal standpoint, there is little difference between the circulating hematopoietic stem cells and any of your other blood cells–they are found in the same place, removed in the same manner, and will be quickly and easily replenished by the donor’s body. The only biological difference is that the cells are at different stages of maturation with different bodily functions, and the only therapeutic difference is the type of disease that can be treated by each type. Thus, the plaintiffs put forward an Equal Protection argument that there was no rational basis for this distinction between mature blood cells and circulating stem cells. And while there is no practical difference between a circulating stem cell and a circulating blood cell, there is a difference between cells and marrow. Peripheral stem cells are not “marrow” inside bones or subparts, just as red blood cells are distinct from red marrow–which is also the source of hematopoietic stem cells. Though the Ninth Circuit narrowed their ruling to distinguishing on the different degrees of pain and coercion of the two types of donation (i.e. policy grounds), they also looked to biological differences between circulating cells and origin tissue, and biological similarities between the stem cells and mature blood cells. Notwithstanding the complaints of the Justice Department, the law must adapt with new scientific discoveries and new medical technology.

Since these stem cells are definitionally regenerative and can be collected with little risk or injury, this ruling is far closer to compensation for plasma donation than creating a market for kidneys or liver lobes. There is one more important difference that mitigates the coercive effect. The donation of a kidney can be a desperate, poorly-considered affair, conceived in times of grave financial distress. If you donate for cash on hand, there may be a limited window to change your mind. Bone marrow (or bone stem cell) donation is very different. Over 7 million people are already in national donor registries (myself included), and contact is rare and delayed; whereas if you agree to donate a healthy kidney, there is little chance it will be refused. This is because HLA-matching is much less important for preventing organ rejection (due to effective immunosuppressive drugs) but more important when trying to prevent graft-versus-host disease (when donor immune cells are attacking the recipient’s “foreign” body). Thus financial awards upon donation will likely not occur for some time, if the donation occurs at all, so there is ample time to reconsider, and a reduced financial incentive for signing up.