e-Brochure

View videos from the Ethics of Cell Therapy Conference.

The Ethics of Cellular Therapy Conference in June 2008 explored the interface of cell therapy treatments and the regulatory and ethical framework in which they exist. The Duke University Translational Research Institute hosted the conference which featured experts on the therapies followed by comment and discussion that led us through the issues that should be considered with each kind of therapy described in this conference. The screening or intervention discussions were followed in each case by a review of the specific ethical considerations that attend the decisions of the patients and their families, the care givers, and the community at large.

Background

Cellular therapies differ from drug or radiation therapies in that a donor is involved in the process. This may be the patient, in which case the condition of the patient and the possible harm that may be done by the cellular collection must be considered in light of possible benefit or harm that may follow. If the donor is other than the patient, the amount of harm that may come to the donor must be considered with the knowledge that the donor will receive no benefit from the donation. The behavior of cells is also not necessarily as predictable as that of drugs- creating the potential for increased or unpredictable risk, particularly in first in man studies.

Along with the ethical considerations of the cell therapy in general the question of screening to find specific cases of individuals who may benefit from the intervention if tested and found early in life provide special challenges. The conference will include experts on screening infants at birth as well as pre-natal screening issues in families where risk has already been established. Under what circumstances is it allowable to do this screening, and what should the patients/families be told concerning this screening? What are the benefits and risks for early intervention in these cases?

The cellular therapy, particularly bone marrow transplantation, usually is given after preparation with chemo/radio therapy and puts the patient at risk for infections and toxicity complications from these preparative therapies. In the case of allogeneic bone marrow transplantation there is a risk of graft versus host disease where the graft itself attacks the host, the patient in this case. Balancing these risks is the possibility of amelioration or cure of their disease, which is rapidly fatal if untreated in most cases. The more complicated ethical case is the one where the disease is morbid, but other treatments exist, such as severe autoimmune conditions and hemoglobinopathies. Transplantation may provide long-term treatment, but comes with a considerable up-front risk.

Cancer vaccines as well as immune recovery vaccines usually include augmentation of the immune response in enriched, cultured cell fractions where the manipulation of the cells is intended to target and intensify the response. The materials used for this purpose may be virus fragments, tumor fragments, or other genetic modification of the cells during culture. Each of these elements give the hope of benefit balanced against the attendant risks associated with each.