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Recruiting NCT05675722

Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Phase I Interventional Congenital Mullerian Duct Anomaly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biologic vaginal-construct implantation.
Who it may be relevant to
Registry conditions: Congenital Mullerian Duct Anomaly. Basic parameters: 15 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Number of Serious Adverse Events [Time frame: Month 36]
  • Quality of Life Scores [Time frame: Baseline]
  • Quality of Life Scores [Time frame: Month 36]
Secondary outcome measures (1)
  • Change in Quality of life Female Sexual Function Index (FSFI) Scores [Time frame: Month 3, Month 6, Month 12, and Month 36]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT05675722 · IRB00091486

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗