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Biologic Implant

Biologic Implant for Vaginal Aplasia (TEV Trial)

Phase 1
Recruiting
Led By Catherine Matthews, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, month 6, month 12, and month 36
Awards & highlights

Summary

This trial tests using a patient's own cells to treat vulvar/vaginal conditions. It isolates special cells from a biopsy to create a tailored treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with surgical procedures such as infection risk at the site of implantation, reaction to anesthesia during surgery and possible complications related to cell transplantation like immune rejection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, month 6, month 12, and month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, month 6, month 12, and month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Serious Adverse Events
Quality of Life Scores
Secondary outcome measures
Change in Quality of life Female Sexual Function Index (FSFI) Scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: autologous vaginal construct for patients with vaginal aplasiaExperimental Treatment1 Intervention
Biologic vaginal construct, surgically implanted into native vaginal site

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,922 Total Patients Enrolled
Catherine Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
663 Total Patients Enrolled

Media Library

Biologic Vaginal-Construct Implantation (Biologic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05675722 — Phase 1
Congenital Mullerian Duct Anomaly Research Study Groups: autologous vaginal construct for patients with vaginal aplasia
Congenital Mullerian Duct Anomaly Clinical Trial 2023: Biologic Vaginal-Construct Implantation Highlights & Side Effects. Trial Name: NCT05675722 — Phase 1
Biologic Vaginal-Construct Implantation (Biologic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675722 — Phase 1
~7 spots leftby Dec 2028
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