Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
Recruiting
Phase 1
Interventional Study
Congenital Mullerian Duct Anomaly
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 15 – 45
- Sex
- Female
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Wake Forest University Health Sciences · Other
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About This Trial
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
Trial Locations
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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…
Contacts