Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

NCT ID: NCT05675722

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2029-12-31

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

Conditions

Congenital Mullerian Duct Anomaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous vaginal construct for patients with vaginal aplasia

Biologic vaginal construct, surgically implanted into native vaginal site

Group Type: EXPERIMENTAL

biologic vaginal-construct implantation

Intervention Type: BIOLOGICAL

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.

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.

Intervention Type: BIOLOGICAL

Eligibility 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
• If a vital sign or lab value results in exclusion, the subject could be rescreened later

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary-Clare Day, RN

Role: CONTACT

mday@wakehealth.edu

336.713.1343

Facility Contacts

Mary-Clare Day, RN

Role: primary

mday@wakehealth.edu

336-713-1343

Other Identifiers

IRB00091486

Identifier Type: -

Identifier Source: org_study_id