Biologic Implant for Vaginal Aplasia

(TEV Trial)

Overseen By Mary-Clare Day, RN

Age: < 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Wake Forest University Health Sciences

Must not be taking: Anti-platelets, Blood thinners, Immunosuppressants, others

Disqualifiers: Autoimmune, HIV, Diabetes, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Baseline

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking anti-platelet medications, blood thinners, or immunosuppressive agents. It's best to discuss your current medications with the trial team.

What is the purpose of this trial?

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

Research Team

Catherine Matthews, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for females aged 15-45 with a rare condition where part or all of the vagina is missing, confirmed by MRI. They must be able to follow study rules and attend follow-up visits. Excluded are those with neurological disorders, tobacco use, active infections in the vaginal area, history of severe scarring or blood disorders, on certain medications like blood thinners or immunosuppressants, recent other clinical trials participation, substance abuse issues, clotting disorders or vital signs outside set ranges.

Inclusion Criteria

I am a woman aged between 15 and 45.

Patients with stable medical comorbidities

I am willing to follow all study rules and come back for follow-up visits.

Exclusion Criteria

Patients with autoimmune disease or immune disorder

I currently have an infection in my vaginal or urinary area.

Patients with a history of keloid scarring

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Vulvar/vaginal Smooth muscle cells and Epithelial Cells are isolated, expanded, and seeded on a scaffold to create a Tissue Engineered Vagina, which is then surgically implanted

Baseline

Follow-up

Participants are monitored for safety and effectiveness, including quality of life and sexual function assessments

36 months

Assessments at Month 3, Month 6, Month 12, and Month 36

Treatment Details

Interventions

• Biologic Vaginal-Construct Implantation

Trial Overview The trial tests implantation of a biological vaginal construct made from patients' own cells. It's a Phase 1 study at one location where smooth muscle and epithelial cells taken from the patient are used to create this personalized treatment for women lacking vaginal tissue due to congenital anomalies.

Participant Groups

Group I: autologous vaginal construct for patients with vaginal aplasia Experimental Treatment 1 Intervention

Biologic vaginal construct, surgically implanted into native vaginal site

Biologic Vaginal-Construct Implantation is already approved in United States for the following indications:

Approved in United States as Biologic Vaginal-Construct Implantation for:

• Vaginal aplasia

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+