Bladders Built in the Lab

Our Review Summary

This story discusses a small observational study of 7 patients who underwent transplantation of a reconstructed man-made bladder. The organ was constructed in a laboratory and the patients' cells were added to the inner and outer layer of the bladder. Cells then attached themselves to the new bladder and it was sutured into the defective bladder, along with a blood-rich tissue to nurture the new organ. The results of this small observational study were published in the British medical journal, The Lancet, though the reporter here chose to focus on anecdotal evidence from one person who underwent the procedure. Surgeons and experts in the field of tissue regeneration are quoted, and they talk positively about the reconstructed bladder and the possibility of other man-made organs; however, there is no quantitative data provided on outcomes of patients who undergo this very new organ transplantation. Reconstructed bladders are not yet approved for commercial purposes, as FDA standards for approval of tissue-based products are similar to those for drugs or medical devices. There is discussion that conventional surgery–intestinal tissue used to reconstruct a bladder– "threatens further health complications". These complications are briefly discussed, and include clogging of the bladder with intestinal mucus or formation of kidney stones, yet there is no mention of potential health problems after surgery for a reconstructed organ, or the possibility of a patient rejecting this organ. This is still a very new procedure and there is not much long-term data on health outcomes from humans with reconstructed bladders. This study is very small (9 recruited, 7 had the transplant), and so results would not be generalizable to a larger population. The cost of the surgery was free to patients in this experimental group. There is no estimate of what the reconstructed bladder procedure might cost outside a clinical trial, however, the reporter made an attempt to get this information from the company that made the bladders for this study, but the company declined to respond. There is no mention of sources' potential conflict of interest or sources of funding for this study. The cost may be free to the patients currently undergoing the transplantation, but someone is paying for the research and surgeons� efforts.