Tissue Therapy of Transsphincteric Anal Fistula
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: ADRC injection, ADRC001 injection.
- Кому может быть актуально
- Состояния в реестре: Anal Fistula. 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
- Дания
- 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
Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
Обзор
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Подробное описание
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.
Вмешательства
- Препарат ADRC injection
Allocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection. - Препарат ADRC001 injection
Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
Первичные конечные точки
- Healing rate (percentage) [Срок оценки: at 6 and 12 months follow-up]
Вторичные конечные точки (7)
- QoL [Срок оценки: at12 months follow-up.]
- Fecal Incontinence [Срок оценки: at12 months follow-up.]
- Risk factors for recurrence of fistula. [Срок оценки: at12 months follow-up.]
- Radiological healing. [Срок оценки: at12 months follow-up.]
- Treatment efficacy. [Срок оценки: at12 months follow-up.]
- Cellular composition [Срок оценки: at 3 months follow-up.]
- Transplantation-related alloantibodies [Срок оценки: at12 months follow-up.]
Критерии участия
Inclusion criterion:
Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:
- able to communicate with Danish language
- able to provide informed consent
- having address in the region of southern Denmark during the study
Критерии исключения
- Signs of suppuration/cavitation around the fistula
- Simple or low anal fistula, which can be treated by simple surgical incision
- Ano-vaginal and recto-vaginal fistula
- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- Inflammatory Bowel Disease
- Immunosuppression (due to clinical condition or medical therapy)
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
- Allergy against the antibiotics: Penicillin and streptomycin.
- Coagulopathy
- Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
- Verified syphilis, HIV, or hepatitis on screening test
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Odense University Hospital — Odense
Идентификаторы
NCT: NCT06303752 · 260-2021-NQ · 2022-502659-73