Congenital Mullerian Duct Anomaly
Conditions
Keywords
Vaginal Abnormality
Brief 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
Detailed 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
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Ten women, ages 15-45 years, meeting criteria will undergo vaginal/vulva biopsy and biologic vaginal-construct implantation.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
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 result * Patients with a history of keloid scarring * Patients who are currently taking anti-platelet medications or blood thinners * Patients with a history of clotting disorder * Patients with autoimmune disease or immune disorder * Patients requiring concomitant use of or treatment with immunosuppressive agents * Patients with a history of systemic conditions, including but not limited to HIV, thrombocytopenia, uncontrolled diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study * Patients with evidence or diagnosis of any primary coagulation disorder (including concomitant anticoagulation therapy at enrollment) * Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study * Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease) * Patients who are current tobacco users * Patients with alcohol/drug abuse problems * Patients with any systemic disease * Patients with any psychiatric disorders * Inability to participate in all necessary study activities due to physical or mental limitations. * Any circumstance in which the investigator deems participation in the study is not in the subject's best interest * The following vital sign cut-off values, laboratory cut-off values and ECG reading will be monitored as the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Adverse Events | Month 36 | bleeding, pain, visceral injury, vaginal scarring, contraction, or infection |
| Quality of Life Scores | Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life Female Sexual Function Index (FSFI) Scores | Month 3, Month 6, Month 12, and Month 36 | 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 |
Countries
United States
Contacts
Primary ContactMary-Clare Day, RN
Outcome results
None listed