Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Recruiting now · Phase 1

Conditions studied: Congenital Mullerian Duct Anomaly

In brief

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

Key facts

Study ID

NCT05675722

Run by

Wake Forest University Health Sciences

People needed

10

Starts

2023-06-01

Expected to finish

2029-12-01

Last updated by the study team

2025-10-14

Who can join

Age: 15 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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