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Идёт набор NCT05396456

Autologous Muscle Fiber Fragment Injections

Без фазы С лечением Fecal Incontinence

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: Muscle Fiber Fragment (MFF) Injections.
Кому может быть актуально
Состояния в реестре: Fecal Incontinence. Базовые параметры: от 18 лет · Все.
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
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Официальное название

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

Обзор

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Подробное описание

The Study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. It is anticipated that these fiber fragments would integrate into the host vascular and neural network.

Вмешательства

  • Процедура Muscle Fiber Fragment (MFF) Injections
    The participant will be treated with an injection of muscle fiber fragments into the external anal sphincter at 3, 6, 9 and 12 o'clock using a 21-gauge needle to a depth of 1-2 cm from the external skin using equal amounts in each quadrant.

Первичные конечные точки

  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [Срок оценки: Month 3]
  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [Срок оценки: Month 6]
  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [Срок оценки: Month 12]
Вторичные конечные точки (5)
  • Change in Fecal Incontinence Quality of Life (FI-QOL) scores [Срок оценки: baseline, Months 3 and 12]
  • Anorectal Manometry (ARM) Pressure scores [Срок оценки: baseline, Months 3 and 12]
  • Internal Anal sphincter (IAS) Pressure scores [Срок оценки: baseline, Months 3 and 12]
  • Rectal Anal Inhibitory Reflex (RAIR) Pressure scores [Срок оценки: baseline, Months 3 and 12]
  • Fecal Incontinence Severity Index (FISI) scores [Срок оценки: baseline, Months 3 and 12]

Критерии участия

Критерии включения

  • 18 years of age
  • participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period
  • participants must score >10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)
  • participants must have had symptoms for at least 12 months
  • participants who have failed standard medical and surgical treatments for FI
  • participant will undergo anorectal manometry (ARM) testing
  • participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees
  • women of childbearing potential must use acceptable contraceptives during this study

Критерии исключения

  • participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage
  • participants with pre-existing ano-rectal pain of any cause
  • participants with incontinence of flatus only
  • chronic watery diarrhea which is the primary cause for fecal incontinence
  • acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)
  • presence of anorectal tumors
  • active proctitis or inflammatory bowel disease
  • previous injection of internal anal sphincter (IAS) with bulking agents
  • participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment
  • participants with a defined bleeding disorder diagnosed and treated by a hematologist
  • other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids
  • participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction
  • women who are pregnant, breastfeeding, or have had a child within the last year
  • participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr >1.5 mg/dl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C > 8 mg/dl)
  • participants with anemia (hemoglobin <10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 times normal) or increased bilirubin >1.5mg/dl
  • participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2
  • rectal prolapse
  • vaginal prolapse beyond the hymen
  • unable to understand informed consent information even with provision of a medical translator

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: NCT05396456 · IRB00085606

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗