Actively Recruiting
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Led by Wake Forest University Health Sciences · Updated on 2025-10-14
10
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with congenital Mullerian duct anomaly including absence or partial loss of the vagina confirmed by pelvic MRI
- Female between 15 and 45 years of age
- Stable medical conditions
- Willing to follow study instructions and attend follow-up visits
You will not qualify if you...
- Surgery in the vaginal area within the past 6 months
- Active vaginal or urinary infection confirmed by exam or culture
- History of keloid scarring
- Currently taking anti-platelet or blood thinning medications
- History of clotting disorders
- Autoimmune or immune disorders
- Use of immunosuppressive agents
- Systemic conditions like HIV, thrombocytopenia, uncontrolled diabetes, chronic liver disease
- Any primary coagulation disorder or anticoagulation therapy at enrollment
- Participation in another investigational study within 30 days
- Neurological disorders such as multiple sclerosis or Parkinson's disease
- Current tobacco use
- Alcohol or drug abuse problems
- Any systemic or psychiatric disease
- Physical or mental limitations preventing study participation
- Investigator judgment deeming participation unsafe
- Vital signs or lab values outside specified safe ranges at biopsy and implant visits, including abnormal blood pressure, pulse, respiratory rate, temperature, liver enzymes, bilirubin, kidney function, HbA1C, hemoglobin, platelets, and oxygen saturation
- Rescreening possible if exclusion due to vital signs or labs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
M
Mary-Clare Day, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here