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
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
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 result
Patients with a history of keloid scarring
Patients who are currently taking anti-platelet medications or blood thinners
Single group
biologic vaginal-construct implantation
Biological/Vaccinebiologic 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.
Number of Serious Adverse Events
bleeding, pain, visceral injury, vaginal scarring, contraction, or infection
Quality of Life Scores
The Quality of Life Scores (QOLS) is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 - the higher score indicates the higher quality of life
Quality of Life Scores
The Quality of Life Scores (QOLS) is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 - the higher score indicates the higher quality of life
Change in Quality of life Female Sexual Function Index (FSFI) Scores
The Female Sexual Function Index (FSFI) is a multidimensional measure of female sexual functioning with 19 items that have ordinal, Likert- type response formats and are scored from 0 (or 1) to 5. The scoring algorithm sums items on each domain/sub-scale and then scales the sums so that each subscale has a maximum score of 6 - The FSFI is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain - Higher scores indicate better functioning
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