RECRUITING

Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Conditions

Congenital Mullerian Duct Anomaly Vaginal Abnormality

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Quick Facts

Study Start:2023-06-01

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05675722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mary-Clare Day, RN

CONTACT

336.713.1343

mday@wakehealth.edu

Principal Investigator

Catherine Matthews, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Catherine Matthews, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01

Study Completion Date2028-12

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

Vaginal Abnormality

Additional Relevant MeSH Terms

Congenital Mullerian Duct Anomaly