Agency Proposes Calling Stem Cells 'Organs'
WASHINGTON (CN) - The Health Resources and Services Administration has proposed to expand the definition of "human organ" in its National Organ and Transplant Act regulations to include "hematopoietic stem cells in peripheral blood." The agency has requested comments on the change.
Hematopoietic stem cells (HSCs) form new blood in the bone marrow, and are also in the circulatory system in small quantities, according to the HRSA, a division of the Department of Health and Human Services. HSCs are what is transferred in a "bone marrow transplant," the proposal says.
Traditionally HSCs have been collected by inserting a needle through the bone, into the marrow, and extracting the blood-forming cells, according to the proposal. The cells are then separated, isolated, and transferred to the recipient.
A new technique called "peripheral blood stem cell aphresis" involves giving a donor medications that stimulate the production of HSCs and their mobilization into the blood stream, allowing collection using a needle in one of the donor's veins, according to the HRSA.
The relative ease with which a person may donate, using the new technique, and the more stringent matching needed for a successful transplant make exploitation of those in medical need of HSC transplantation more likely than for "solid organ transplantation," the action says. It notes that dangers include turning HSCs into commodities; coercion and exploitation; and the likelihood of disease transmission resulting from paid donations.
Congress banned offering compensation to organ donors with the National Organ Transplant Act (NOTA) in 1984 to thwart exploitation of organ recipients. The act provides a $50,000 fine and up to a five-year prison term for people involved in trafficking human organs. The act was amended in 1988 to broaden the term "organ" to include any "subpart thereof," which includes bone marrow, and established the Bone Marrow Donor Registry. The registry was later renamed the C.W. Bill Young Cell Transplantation Program. Enacted in 2005 and reinstituted in 2010, the statute defines "bone marrow" as "the cells found in adult bone marrow and peripheral blood," according to the action.
A 2009 lawsuit challenged the criminal ban on offering compensation to marrow donors.
Doreen Flynn of Lewiston, Maine, who has three children with Fanconia anemia, teamed up with the Institute for Justice, a civil liberties law firm based in Arlington, Va., to fight the ban.
"NOTA's criminal ban violates equal protection because it arbitrarily treats renewable bone marrow like nonrenewable solid organs instead of like other renewable or inexhaustible cells - such as blood - for which compensated donation is legal," the institute said in a press release.
The district court found multiple bases for the prohibition, according to the action, but in 2012, a Ninth Circuit panel held there was "no constitutional question since the aphresis method of marrow harvesting was not covered by the statutory prohibition on the transfer of organs for 'valuable consideration,'" the agency explained.
The court did recognize, however, that "the HHS Secretary had regulatory authority to define peripheral blood stem cells as organs. The effect of exercising this authority through this proposed amendment is to clarify that HSCs are covered by the prohibition on transfers of human organs for valuable consideration found in NOTA [regulations]," regardless of the method of their collection.
Comments are due by Dec. 2.