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Идёт набор NCT05675722

Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

Фаза I С лечением Congenital Mullerian Duct Anomaly

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: biologic vaginal-construct implantation.
Кому может быть актуально
Состояния в реестре: Congenital Mullerian Duct Anomaly. Базовые параметры: 15 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

The cells are expanded in vitro and seeded on scaffold and matured - The final Tissue Engineered Vagina (TEV) is implanted into the native vaginal site

Вмешательства

  • Биопрепарат biologic vaginal-construct implantation
    biologic Tissue Engineered Vagina (TEV), which provides an epithelial layer for the luminal aspect and a smooth muscle layer for protecting the openness of the hollow tube, mimicking the cellular orientation and architecture of the vagina. Autologous cells isolated from vagina/vulva remnants offset any potential for immunological rejection.

Первичные конечные точки

  • Number of Serious Adverse Events [Срок оценки: Month 36]
  • Quality of Life Scores [Срок оценки: Baseline]
  • Quality of Life Scores [Срок оценки: Month 36]
Вторичные конечные точки (1)
  • Change in Quality of life Female Sexual Function Index (FSFI) Scores [Срок оценки: Month 3, Month 6, Month 12, and Month 36]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT05675722 · IRB00091486

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗