Recruiting
Phase 1

Vaginal Construct

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05675722

Conditions

Congenital Mullerian Duct Anomaly

Eligibility Criteria

Sex: Female

Age: 15 - 45

Healthy Volunteers: Not accepted

Interventions

biologic vaginal-construct implantation

Study Details

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

Conditions

Congenital Mullerian Duct Anomaly

Study ID

NCT05675722

Start date

Jun 1, 2023

Status verified date

Oct, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: autologous vaginal construct for patients with vaginal aplasia

Biologic vaginal construct, surgically implanted into native vaginal site

Interventions

biologic 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.

Primary outcome measure

  • Number of Serious Adverse Events [ Time Frame: Month 36 ]
  • Quality of Life Scores [ Time Frame: Baseline ]
  • Quality of Life Scores [ Time Frame: Month 36 ]

Central Contacts and Locations

Central contacts

Mary-Clare Day, RN

336.713.1343mday@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Mary-Clare Day, RN

336-713-1343mday@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Vaginal Abnormality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-10-14.