NCT05675722PHASE1Recruiting
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Wake Forest University Health Sciences
Start Date
6/1/2023
Completion Date
12/1/2029
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
Eligibility Criteria
Age Range: 15 years to 45 years
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
Interventions
BIOLOGICAL
biologic vaginal-construct implantation
Conditions
Congenital Mullerian Duct Anomaly
Locations
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States