Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Conditions

• Congenital Mullerian Duct Anomaly

Eligibility Criteria

Sex

FEMALE

Age

15 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• biologic vaginal-construct implantation — 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.

Study Details

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

Key Dates

Start date

Jun 1, 2023

Status verified

Oct 2025

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: autologous vaginal construct for patients with vaginal aplasia
  Biologic vaginal construct, surgically implanted into native vaginal site

Primary Outcome Measure

Number of Serious Adverse Events [ Time Frame: Month 36 ]

Central Contacts

• Mary-Clare Day, RN
  336.713.1343
  [email protected]

Locations (1)

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