Congenital Mullerian Duct AnomalyPhase 1TEVNCT05675722
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
A Phase 1 study testing biologic vaginal-construct implantation in people with Congenital Mullerian Duct Anomaly, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Congenital Mullerian Duct Anomaly
- What is being tested?
- biologic vaginal-construct implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Mary-Clare Day, RN, 336-713-1343, mday@wakehealth.edu
About this study
Official title: Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
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
Read the 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
- Conditions
- Congenital Mullerian Duct Anomaly
- Being tested
- biologic vaginal-construct implantation
- Keywords
- Vaginal Abnormality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic vaginal-construct implantationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| autologous vaginal construct for patients with vaginal aplasia | Experimental | Biologic vaginal construct, surgically implanted into native vaginal site Receives: Biological: biologic vaginal-construct implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events
bleeding, pain, visceral injury, vaginal scarring, contraction, or infection
Measured: 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
Measured: 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
Measured: Month 36
Secondary outcomes (1)
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
Measured: Month 3, Month 6, Month 12, and Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jun 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Mullerian Duct AnomalyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ten women, ages 15-45 years, meeting criteria will undergo vaginal/vulva biopsy and biologic vaginal-construct implantation.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Matthews, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675722
- Sponsor's protocol ID
- IRB00091486
- Acronym
- TEV
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
- ClinicalTrials.gov ID
- NCT05675722
- Acronym / sponsor ID
- TEV / IRB00091486
- Conditions
- Congenital Mullerian Duct Anomaly
- Keywords
- Vaginal Abnormality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ten women, ages 15-45 years, meeting criteria will undergo vaginal/vulva biopsy and biologic vaginal-construct implantation.
| Arm | Type | Receives |
|---|---|---|
| autologous vaginal construct for patients with vaginal aplasia | Experimental | Biological: biologic vaginal-construct implantationBiologic vaginal construct, surgically implanted into native vaginal site |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic vaginal-construct implantationbiologic 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. | Biological | autologous vaginal construct for patients with vaginal aplasia |
Primary outcome
Number of Serious Adverse Events
Time frame: Month 36
bleeding, pain, visceral injury, vaginal scarring, contraction, or infection
Quality of Life Scores
Time frame: 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
Quality of Life Scores
Time frame: Month 36
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
1 secondary outcome
Change in Quality of life Female Sexual Function Index (FSFI) Scores
Time frame: Month 3, Month 6, Month 12, and Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Matthews, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing biologic vaginal-construct implantation in people with Congenital Mullerian Duct Anomaly, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary-Clare Day, RN (336.713.1343, mday@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events (time frame: Month 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.