Techno-borne Organs: Medical, Legal, and Policy Concerns

Abstract

Techno-borne organs (TBO) are promising organ-repair strategies in a broad spectrum of terminal diseases. Their benefit/risk ratio is debated in medical, legal, and religious circles. An attempt was made to elucidate risks and advantages in implication of the TBO. Findings suggest that the TBO, created from either autologous, syngenic or isogenic cells, is an auspicious frontier that eliminates risks associated to the traditional transplantation of the donor organs: incompatibility, transplant failure, long waiting lists, health insurance constraints, fraud, conspiracy, and increasing number of lawsuits. On the other hand, the TBO emerge with specific disadvantages. Medical risks are associated with the cell-scaffold interactions, TBO’s sterility and the potential to replicate in vivo. New parametric standards are necessary to determine the TBO transplant’s success or failure. Regulatory issues include the Coordinating Committee’s current federal oversight limited for the commercial products. Rejoining of the NSF and NIH to the Coordination Committee would help expand the regulations to assess scientific novelty and upstream. Potential legal issues may include TBO patentability (matter, process, nonobviousness, novelty), patient’s substantive due process rights of bodily integrity and TBO ownership under the 14th Amendment, advance directives for autopsy of a TBO carrier, and the extent of publishing an invention - a shared property between the scientist and the patient.