Biologic Implant for Vaginal Aplasia

(TEV Trial)

Overseen By Mary-Clare Day, RN

Age: < 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Wake Forest University Health Sciences

Must not be taking: Anti-platelets, Blood thinners, Immunosuppressants, others

Disqualifiers: Autoimmune, HIV, Diabetes, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Baseline

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for women diagnosed with vaginal aplasia, a condition where the vagina is absent or underdeveloped. The study involves implanting a biologic construct made from the patient's own cells to create or reconstruct vaginal tissue. Known as Biologic Vaginal-Construct Implantation, this procedure is primarily for women confirmed to have this condition through an MRI scan. Participants should not have had recent surgeries in the area or have certain medical issues like infections or clotting disorders. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking anti-platelet medications, blood thinners, or immunosuppressive agents. It's best to discuss your current medications with the trial team.

What prior data suggests that this biologic implant is safe for vaginal aplasia?

Research shows that the biologic vaginal-construct implantation, made from a patient’s own cells, is still being tested for safety in this trial. Although specific safety results from this study are not yet available, related research may provide insight.

In similar procedures, using a patient's own cells for reconstruction has generally been safe and well-tolerated. For instance, studies on other types of vaginal reconstructions using a person’s own tissue have shown safety, with patients reporting good sexual function and appearance.

However, since this trial is in its early stages, the main focus is on safety. Researchers are beginning to observe how the treatment works in people and are closely monitoring for any side effects, such as unexpected symptoms or reactions.

In summary, while specific safety data for this treatment is not yet available, past research on similar procedures suggests it could be safe. However, this trial remains in the early testing phase. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the biologic vaginal-construct implantation because it offers a new approach for treating vaginal aplasia. Unlike the standard treatments, which often involve surgical creation of a neovagina using tissue grafts or dilation techniques, this method uses a biologic implant derived from the patient's own cells. This personalized approach aims to enhance tissue integration and reduce the risk of rejection, potentially leading to more natural and sustainable outcomes. Additionally, the use of a biologic construct could simplify the recovery process and improve overall patient comfort and satisfaction.

What evidence suggests that the Biologic Vaginal-Construct Implantation might be an effective treatment for vaginal aplasia?

Research has shown that biologic implants could offer a promising treatment for vaginal aplasia, a condition where the vagina does not develop properly. In this trial, participants will receive an autologous vaginal construct, using the patient's own cells to help prevent implant rejection. Studies on patients with similar conditions have found that these engineered vaginal tissues can successfully integrate with the body and remain healthy. Specifically, a previous study with patients who have Mayer-Rokitansky-Küster-Hauser syndrome demonstrated that these tissue-engineered vaginal organs functioned well and persisted in the body, offering hope for those with vaginal aplasia. ^{2 6 7 8 9}

Who Is on the Research Team?

Catherine Matthews, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for females aged 15-45 with a rare condition where part or all of the vagina is missing, confirmed by MRI. They must be able to follow study rules and attend follow-up visits. Excluded are those with neurological disorders, tobacco use, active infections in the vaginal area, history of severe scarring or blood disorders, on certain medications like blood thinners or immunosuppressants, recent other clinical trials participation, substance abuse issues, clotting disorders or vital signs outside set ranges.

Inclusion Criteria

I am a woman aged between 15 and 45.

Patients with stable medical comorbidities

I am willing to follow all study rules and come back for follow-up visits.

Exclusion Criteria

Patients with autoimmune disease or immune disorder

I currently have an infection in my vaginal or urinary area.

Patients with a history of keloid scarring

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Vulvar/vaginal Smooth muscle cells and Epithelial Cells are isolated, expanded, and seeded on a scaffold to create a Tissue Engineered Vagina, which is then surgically implanted

Baseline

Follow-up

Participants are monitored for safety and effectiveness, including quality of life and sexual function assessments

36 months

Assessments at Month 3, Month 6, Month 12, and Month 36

What Are the Treatments Tested in This Trial?

Interventions

• Biologic Vaginal-Construct Implantation

Trial Overview The trial tests implantation of a biological vaginal construct made from patients' own cells. It's a Phase 1 study at one location where smooth muscle and epithelial cells taken from the patient are used to create this personalized treatment for women lacking vaginal tissue due to congenital anomalies.

How Is the Trial Designed?

Group I: autologous vaginal construct for patients with vaginal aplasia Experimental Treatment 1 Intervention

Biologic vaginal construct, surgically implanted into native vaginal site

Biologic Vaginal-Construct Implantation is already approved in United States for the following indications:

Approved in United States as Biologic Vaginal-Construct Implantation for:

• Vaginal aplasia

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. withpower.com withpower.com/trial/phase-1-congenital-mullerian-duct-anomaly-2-2023-95ebf

Biologic Implant for Vaginal Aplasia (TEV Trial) It's a Phase 1 study at one location where smooth muscle and epithelial cells taken from the patient are used to create this personalized treatment for women ...

2. clinicaltrial.be clinicaltrial.be/en/details/187893?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Implantation Of Vaginal Construct For Patients With Vagin... Autologous cells isolated from vagina/vulva remnants offset any potential for immunological rejection. Primary outcomes. 1. Number of Serious ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24726478/

Tissue-engineered autologous vaginal organs in patients We assessed the use of engineered vaginal organs in four patients with vaginal aplasia caused by Mayer-Rokitansky-Küster-Hauser syndrome (MRKHS).

4. ctv.veeva.com ctv.veeva.com/study/implantation-of-vaginal-construct-for-patients-with-vaginal-aplasia

Implantation Of Vaginal Construct For Patients With Vaginal ... In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1931524416301530

Novel three-dimensional autologous tissue-engineered ... These vaginal grafts could survive to in vivo implantation, maintain tissue maturity, and integrate into host tissues. Smooth muscle and endothelial cells can ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05675722

NCT05675722 | Implantation Of Vaginal Construct For Patients ... Interventional Model Description: Ten women, ages 15-45 years, meeting criteria will undergo vaginal/vulva biopsy and biologic vaginal-construct implantation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10643009/

Long term sexual outcomes of Mayer Rokitansky Küster ... The Uncu-modified Davydov procedure has been demonstrated to be a safe and effective treatment option with high female sexual function index scores for ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465014014216

Autologous In Vitro Cultured Vaginal Tissue for ... The modified Abbè-McIndoe technique with autologous vaginal tissue appears to be safe and feasible. This technique allows normal and satisfying sexual ...

9. researchgate.net researchgate.net/publication/350140773_XCM_Biologic_Tissue_Matrix_xenograft_and_autologous_micromucosa_graft_for_vaginal_reconstruction_in_Mayer-Rokitansky-Kuster-Hauser_syndrome

(PDF) XCM Biologic Tissue Matrix xenograft and ... In our case, we found this procedure to be safe and effective, resulting in satisfactory sexual function and good cosmetic results, without ...