Implanting a tissue-engineered vagina for women with vaginal aplasia
Official title: Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Run by Wake Forest University Health Sciences · NCT05675722 · Data updated 2026-11-12
This study is testing a new way to create and implant a tissue-engineered vagina for women who were born without one, to help restore normal vaginal function.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years to 45 Years |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT05675722 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 15 to 45 with a confirmed diagnosis of congenital Mullerian duct anomaly and stable medical conditions.
✕Probably not a fit
Patients with recent surgeries in the target area, active infections, or certain systemic conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 clinical trial focuses on women diagnosed with congenital Mullerian duct anomalies, specifically those with absent or partially obliterated vaginas. The study involves isolating smooth muscle and epithelial cells from the patient's own biopsy, expanding these cells in vitro, and then seeding them onto a scaffold to create a tissue-engineered vagina. This engineered construct is then implanted into the patient's native vaginal site to restore vaginal function.
Why it matters
Potential benefit: If successful, this approach could provide a functional vaginal construct for patients with congenital vaginal abnormalities, significantly improving their quality of life.
How similar studies have gone: While this approach is innovative, similar studies involving tissue engineering for reconstructive purposes have shown promise, but this specific application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 exclusion criteria in the biopsy visit and again before the implantation surgery BP systolic \>160 or \<90 millimeters of mercury (mmHg) or diastolic \>100 or\<60 millimeters of mercury (mmHg) Pulse \<60 or \>105bpm Respiratory Rate \< 9 and \>20 Temp \> 100.4 degrees Fahrenheit Liver enzymes \>2 times the upper limit of normal (ULN) Abnormal bilirubin unless subject has Gilbert's glomerular filtration rate (eGFR) \< 60 mL/min/ 1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) HbA1C \> 8% Hb \<10 mg/dL Platelet Count \<100,000 O2 saturation \<95% * If a vital sign or lab value results in exclusion, the subject could be rescreened later
Where it's running
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Catherine Matthews, MD — Wake Forest University Health Sciences
- Study coordinator: Mary-Clare Day, RN
- Email: mday@wakehealth.edu
- Phone: 336.713.1343
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.