Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Wake Forest University Health Sciences
Summary
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
Description
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
Eligibility
- Age range
- 15–45 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- Biologicalbiologic vaginal-construct implantation
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.
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina