Implantation Of Vaginal Construct For Patients With Vaginal Aplasia (TEV)

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

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

Study Overview

• Status: Recruiting
• Conditions: Congenital Mullerian Duct Anomaly
• Intervention / Treatment: Biological: biologic vaginal-construct implantation

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mary-Clare Day, RN; Phone Number: 336.713.1343; Email: mday@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Mary-Clare Day, RN; Phone Number: 336-713-1343; Email: mday@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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
• Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
• Patients who are current tobacco users
• Patients with alcohol/drug abuse problems
• Patients with any systemic disease
• Patients with any psychiatric disorders
• Inability to participate in all necessary study activities due to physical or mental limitations.
• Any circumstance in which the investigator deems participation in the study is not in the subject's best interest
• The following vital sign cut-off values, laboratory cut-off values and ECG reading will be monitored as the exclusion criteria in the biopsy visit and again before the implantation surgery BP systolic >160 or <90 millimeters of mercury (mmHg) or diastolic >100 or<60 millimeters of mercury (mmHg) Pulse <60 or >105bpm Respiratory Rate < 9 and >20 Temp > 100.4 degrees Fahrenheit Liver enzymes >2 times the upper limit of normal (ULN) Abnormal bilirubin unless subject has Gilbert's glomerular filtration rate (eGFR) < 60 mL/min/ 1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) HbA1C > 8% Hb <10 mg/dL Platelet Count <100,000 O2 saturation <95%
• If a vital sign or lab value results in exclusion, the subject could be rescreened later

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autologous vaginal construct for patients with vaginal aplasia; Biologic vaginal construct, surgically implanted into native vaginal site	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events	bleeding, pain, visceral injury, vaginal scarring, contraction, or infection	Month 36
Quality of Life Scores	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	Baseline
Quality of Life Scores	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	Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of life Female Sexual Function Index (FSFI) Scores	The Female Sexual Function Index (FSFI) is a multidimensional measure of female sexual functioning with 19 items that have ordinal, Likert- type response formats and are scored from 0 (or 1) to 5. The scoring algorithm sums items on each domain/sub-scale and then scales the sums so that each subscale has a maximum score of 6 - The FSFI is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain - Higher scores indicate better functioning	Month 3, Month 6, Month 12, and Month 36

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Catherine Matthews, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: December 29, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Vaginal Abnormality
• Other Study ID Numbers: IRB00091486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No