Clinical trial NCT05675722: Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Official title: Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Congenital Mullerian Duct Anomaly
Keywords: Vaginal Abnormality
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten women, ages 15-45 years, meeting criteria will undergo vaginal/vulva biopsy and biologic vaginal-construct implantation.
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: Month 36
measure: Quality of Life Scores
timeFrame: Baseline
measure: Quality of Life Scores
timeFrame: Month 36
Secondary outcomes:
measure: Change in Quality of life Female Sexual Function Index (FSFI) Scores
timeFrame: Month 3, Month 6, Month 12, and Month 36
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Catherine Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: