NCT05675722

Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2023-01-09
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study