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Biologic Implant for Vaginal Aplasia (TEV Trial)
TEV Trial Summary
This trial tests using a patient's own cells to treat vulvar/vaginal conditions. It isolates special cells from a biopsy to create a tailored treatment.
TEV Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEV Trial Design
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Who is running the clinical trial?
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- I currently have an infection in my vaginal or urinary area.I am currently on blood thinners or anti-platelet medications.I cannot do all study activities because of my health or mental condition.I have a neurological disorder like multiple sclerosis or Parkinson's disease.I am currently using or need immunosuppressive medication.I have a blood clotting disorder or am on blood thinners.I had surgery in the area being studied less than 6 months ago.I am a woman aged between 15 and 45.I am willing to follow all study rules and come back for follow-up visits.I have a condition that affects my whole body.I have a history of blood clots.I have a birth defect of my reproductive system confirmed by an MRI.
- Group 1: autologous vaginal construct for patients with vaginal aplasia
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this experiment soliciting participants who are octogenarian or older?
"As outlined in the enrollment requirements, participants must be aged 15-45 years old to qualify for this medical trial."
Are any slots available for enrollment in this experiment?
"Clinicaltrials.gov indicates that this medical trial, which was initially posted on March 1st 2023 and last modified on December 29th 2022, is not presently enrolling participants. Nevertheless, there are still a number of other trials looking for candidates."
How efficacious is autologous vaginal construct for individuals with vaginal aplasia?
"Our team at Power believes that the safety of autologous vaginal construct for patients with vaginal aplasia is minimal, awarding it a score of 1. This rating reflects its status as being in Phase 1 trials, where there are limited studies supporting both efficacy and security."
Do I meet the requirements for admission to this medical experiment?
"The clinical trial seeks 10 female recruits, aged 15-45 years old and diagnosed with congenital Mullerian duct anomaly. To meet the inclusion criteria, individuals must have a confirmed diagnosis of this condition via pelvic MRI scan, stable comorbidities, as well as an agreement to comply with all study instructions and return for follow up visits."
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