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

Wake Forest University Health Sciences1 site in 1 country10 target enrollmentJune 1, 2023

ConditionsCongenital Mullerian Duct Anomaly

Interventionsbiologic vaginal-construct implantation

Drugsbiologic vaginal-construct implantation

Overview

Phase: Phase 1
Intervention: biologic vaginal-construct implantation
Conditions: Congenital Mullerian Duct Anomaly
Sponsor: Wake Forest University Health Sciences
Enrollment: 10
Locations: 1
Primary Endpoint: Quality of Life Scores
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 1, 2023

End Date

December 1, 2029

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Wake Forest University Health Sciences

Responsible Party

Sponsor

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

Arms & Interventions

autologous vaginal construct for patients with vaginal aplasia

Biologic vaginal construct, surgically implanted into native vaginal site

Intervention: biologic vaginal-construct implantation

Outcomes

Primary Outcomes

Quality of Life Scores

Time Frame: Month 36

The Quality of Life Scores (QOLS) is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 - the higher score indicates the higher quality of life

Number of Serious Adverse Events

Time Frame: Month 36

bleeding, pain, visceral injury, vaginal scarring, contraction, or infection