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

Wake Forest University (WFU)

Status and phase

Enrolling

Phase 1

Conditions

Congenital Mullerian Duct Anomaly

Treatments

Biological: biologic vaginal-construct implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT05675722

IRB00091486

Details and patient eligibility

About

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

Full 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

Enrollment

10 estimated patients

Sex

Female

Ages

15 to 45 years old

Volunteers

No Healthy Volunteers

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