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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
RECRUITINGNumber of Serious Adverse Events
bleeding, pain, visceral injury, vaginal scarring, contraction, or infection
Time frame: Month 36
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
Time frame: Baseline
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
Time frame: Month 36
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
Time frame: Month 3, Month 6, Month 12, and Month 36
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