Tissue-engineered autologous urethras for patients who need reconstruction: an observational study.
Level 4 - case-series / case-control
Prospective single-arm case series of 5 patients without a control group.
PubMed 21388673 · doi:10.1016/S0140-6736(10)62354-9
What was done
Five boys (median age 11 years, range 10–14) with complex urethral defects underwent reconstruction using autologous tissue-engineered urethras. Muscle and epithelial cells were harvested via biopsy, expanded, and seeded onto tubularised polyglycolic acid:poly(lactide-co-glycolide acid) scaffolds before surgical implantation. Patients were followed for up to 72 months with International Continence Society questionnaires, urine analyses, flow measurements, cystourethroscopy, cystourethrography, and serial endoscopic biopsies at 3, 12, and 36 months.
What was found
Over a median follow-up of 71 months (range 36–76), the median final maximum urinary flow rate was 27.1 mL/s (range 16–28). Serial radiographic and endoscopic assessments showed maintenance of wide urethral calibres without strictures. Urethral biopsies showed development of normal-appearing architecture by 3 months post-implantation, with AE1/AE3, α-actin, desmin, and myosin antibodies confirming epithelial and muscle lineages in all cultures.
Why it matters
This study provides long-term proof-of-concept for up to 6 years that autologous cell-seeded bioresorbable scaffolds can structurally and functionally replace damaged urethral segments without recurrent strictures.
Limits
The study is an uncontrolled case series with a very small sample size (n = 5). All participants were pediatric males, limiting generalizability to adult patients, female anatomy, or broader etiologies of urethral damage.
Cited by
- supports Anthony Atala has engineered organs including the bladder, urethra, and esophagus, as well as full-thickness skin for transplantation using stem cells.