Wake Forest University Health Sciences
In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy
The cells are expanded in vitro and seeded on scaffold and matured - The final Tissue Engineered Vagina (TEV) is implanted into the native vaginal site
Inclusion Criteria: * Diagnosed with congenital Mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic MRI * Females between the ages of 15 and 45 years * Patients with stable medical comorbidities * Patients that are willing to comply with all study instructions and are willing to return for study follow-up visits Exclusion Criteria: * Patients with a history of surgery in the target area more recent than the last 6 months * Patients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture…
biologic Tissue Engineered Vagina (TEV), which provides an epithelial layer for the luminal aspect and a smooth muscle layer for protecting the openness of the hollow tube, mimicking the cellular orientation and architecture of the vagina. Autologous cells isolated from vagina/vulva remnants offset any potential for immunological rejection.
Arctuva estimate
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